Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Lymphoma, Leukemia |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 1 - 31 |
Updated: | 1/1/2014 |
Start Date: | March 2009 |
A Phase II Pilot Trial of Bortezomib (PS-341, Velcade®, IND #58,443) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
This phase II trial is studying the side effects of giving bortezomib together with
combination chemotherapy and to see how well it works in treating young patients with
relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the
growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in
chemotherapy work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Giving bortezomib together with combination
chemotherapy may kill more cancer cells.
combination chemotherapy and to see how well it works in treating young patients with
relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the
growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in
chemotherapy work in different ways to stop the growth of cancer cells, either by killing
the cells or by stopping them from dividing. Giving bortezomib together with combination
chemotherapy may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To estimate the toxicity, second complete response (CR2) rate at the end of Block 1
therapy, and 4-month event-free survival (EFS) for pediatric and young adult patients with
relapsed acute lymphoblastic leukemia (ALL) treated with bortezomib in combination with
intensive re-Induction chemotherapy.
II. To evaluate bortezomib pharmacokinetics (PK) in patients receiving the combination
regimen.
SECONDARY OBJECTIVES:
I. To assess minimal residual disease (MRD) in bone marrow following completion of each
therapy block.
II. To assess the feasibility of measuring leukemia initiating cells (LIC) in patient
samples before and after chemotherapy.
III. To discover biologic pathways associated with response and drug resistance using gene
and protein expression profiles at baseline and following initial exposure to chemotherapy.
IV. To determine if bortezomib inhibits lymphoblast NF-kappa-B activity in leukemia
patients.
OUTLINE:
REINDUCTION BLOCK 1: Patients receive cytarabine intrathecally (IT) on day 1; vincristine
sulfate IV on days 1, 8, 15, and 22; doxorubicin hydrochloride IV over 15 minutes on day 1;
oral prednisone twice daily on days 1-29; bortezomib IV on days 1, 4, 8, and 11; and
pegaspargase intramuscularly (IM) on days 2, 8, 15, and 22. Patients with central nervous
system (CNS)-negative disease (CNS1 or CNS2) also receive methotrexate IT on days 15 and 29;
patients with CNS-positive disease (CNS3) receive triple intrathecal therapy (TIT)
comprising methotrexate, hydrocortisone, and cytarabine IT on days 8, 15, 22, and 29. After
completion of reinduction block 1, patients with ALL and M2 or M3 bone marrow proceed
directly to reinduction block 2. Patients with ALL and M1 bone marrow or lymphoblastic
lymphoma proceed to reinduction block 2 after blood counts recover. Patients with persistent
cerebral spinal fluid (CSF) blasts after 6 doses of TIT or patients with progressive
lymphoblastic lymphoma are removed from the study.
REINDUCTION BLOCK 2: Patients receive etoposide phosphate IV over 1-2 hours on days 1-5;
cyclophosphamide IV over 1 hour on days 1-5; bortezomib IV on days 1, 4, and 8; filgrastim
(G-CSF) subcutaneously (SC) or IV daily beginning on day 6 and continuing until blood counts
recover*; high-dose methotrexate IV on day 22; and leucovorin calcium orally or IV every 6
hours on days 23 and 24. Patients with CNS-negative disease also receive methotrexate IT on
days 1 and 22; patients with CNS-positive disease receive TIT on days 1 and 22. After
completion of reinduction block 2, patients proceed to reinduction block 3 immediately or
when blood counts recover. Patients with disease progression are removed from the study.
NOTE: *Patients do not receive G-CSF on day 8.
REINDUCTION BLOCK 3: Patients receive cytarabine IV over 3 hours twice daily on days 1, 2,
8, and 9; L-asparaginase IM on days 2 and 9; and G-CSF SC or IV daily beginning on day 10
and continuing until blood counts recover.
After completion of study treatment, patients are followed every 6 months for 3 years and
then annually for 2 years.
I. To estimate the toxicity, second complete response (CR2) rate at the end of Block 1
therapy, and 4-month event-free survival (EFS) for pediatric and young adult patients with
relapsed acute lymphoblastic leukemia (ALL) treated with bortezomib in combination with
intensive re-Induction chemotherapy.
II. To evaluate bortezomib pharmacokinetics (PK) in patients receiving the combination
regimen.
SECONDARY OBJECTIVES:
I. To assess minimal residual disease (MRD) in bone marrow following completion of each
therapy block.
II. To assess the feasibility of measuring leukemia initiating cells (LIC) in patient
samples before and after chemotherapy.
III. To discover biologic pathways associated with response and drug resistance using gene
and protein expression profiles at baseline and following initial exposure to chemotherapy.
IV. To determine if bortezomib inhibits lymphoblast NF-kappa-B activity in leukemia
patients.
OUTLINE:
REINDUCTION BLOCK 1: Patients receive cytarabine intrathecally (IT) on day 1; vincristine
sulfate IV on days 1, 8, 15, and 22; doxorubicin hydrochloride IV over 15 minutes on day 1;
oral prednisone twice daily on days 1-29; bortezomib IV on days 1, 4, 8, and 11; and
pegaspargase intramuscularly (IM) on days 2, 8, 15, and 22. Patients with central nervous
system (CNS)-negative disease (CNS1 or CNS2) also receive methotrexate IT on days 15 and 29;
patients with CNS-positive disease (CNS3) receive triple intrathecal therapy (TIT)
comprising methotrexate, hydrocortisone, and cytarabine IT on days 8, 15, 22, and 29. After
completion of reinduction block 1, patients with ALL and M2 or M3 bone marrow proceed
directly to reinduction block 2. Patients with ALL and M1 bone marrow or lymphoblastic
lymphoma proceed to reinduction block 2 after blood counts recover. Patients with persistent
cerebral spinal fluid (CSF) blasts after 6 doses of TIT or patients with progressive
lymphoblastic lymphoma are removed from the study.
REINDUCTION BLOCK 2: Patients receive etoposide phosphate IV over 1-2 hours on days 1-5;
cyclophosphamide IV over 1 hour on days 1-5; bortezomib IV on days 1, 4, and 8; filgrastim
(G-CSF) subcutaneously (SC) or IV daily beginning on day 6 and continuing until blood counts
recover*; high-dose methotrexate IV on day 22; and leucovorin calcium orally or IV every 6
hours on days 23 and 24. Patients with CNS-negative disease also receive methotrexate IT on
days 1 and 22; patients with CNS-positive disease receive TIT on days 1 and 22. After
completion of reinduction block 2, patients proceed to reinduction block 3 immediately or
when blood counts recover. Patients with disease progression are removed from the study.
NOTE: *Patients do not receive G-CSF on day 8.
REINDUCTION BLOCK 3: Patients receive cytarabine IV over 3 hours twice daily on days 1, 2,
8, and 9; L-asparaginase IM on days 2 and 9; and G-CSF SC or IV daily beginning on day 10
and continuing until blood counts recover.
After completion of study treatment, patients are followed every 6 months for 3 years and
then annually for 2 years.
Inclusion Criteria:
- Diagnosis of 1 of the following:
- Pre-B acute lymphoblastic leukemia (ALL) in first early (< 36 months from
diagnosis) isolated bone marrow or combined bone marrow/extramedullary relapse
as documented by histology and immunophenotyping
- T-cell ALL in first isolated bone marrow or combined relapse as documented by
histology and immunophenotyping
- T-cell lymphoblastic lymphoma in first relapse as documented by histology
- Measurable disease as documented by clinical, radiographic, or histologic
criteria
- Relapsed or refractory to conventional therapy
- No Philadelphia chromosome-positive (Ph+) ALL unless refractory to ≥ 1 tyrosine
kinase inhibitor therapy
- Patients who are unable to tolerate tyrosine kinase inhibitor therapy due to
toxicity are eligible
- No mature B-cell ALL (i.e., sIg positive and kappa or lambda restricted positivity)
with French-American-British Cooperative Group (FAB) L3 morphology and/or myc
translocation
- No known optic nerve and/or retinal involvement
- Patients presenting with visual disturbances should have an ophthalmological
exam and, if indicated, a magnetic resonance imaging (MRI) to determine optic
nerve or retinal involvement
- No extramedullary disease (i.e., isolated CNS disease or isolated testicular disease)
- No concurrent genetic syndrome (e.g., Down syndrome, Fanconi anemia, Kostmann
syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome)
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and
Lansky for patients ≤ 16 years of age
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
maximum serum creatinine based on age/gender as follows:
- 0.4 mg/dL (for patients 1 to 5 months of age)
- 0.5 mg/dL (for patients 6 to 11 months of age)
- 0.6 mg/dL (for patients 1 year of age)
- 0.8 mg/dL (for patients 2 to 5 years of age)
- 1 mg/dL (for patients 6 to 9 years of age)
- 1.2 mg/dL (for patients 10 to 12 years of age)
- 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age)
- 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age)
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- Serum glutamate pyruvate transaminase (SPGT) (alanine aminotransferase [ALT]) < 3
times ULN for age (unless elevation due to leukemia infiltration)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated
radionuclide study
- Pulse oximetry ≥ 94% at sea level (> 90% if at high altitude)
- No evidence of dyspnea at rest or exercise intolerance
- No evidence of acute pulmonary infiltrates on chest radiograph
- No known allergy to doxorubicin, cytarabine, etoposide, etoposide phosphate, boron,
mannitol, or bortezomib
- No CNS toxicity > grade 2
- Seizure disorder allowed provided patient is on anticonvulsants (e.g.,
benzodiazepines or gabapentin) and it is well controlled
- Able to receive asparaginase (i.e., no prior severe pancreatitis, stroke, or other
toxicity)
- Patients who initially receive asparaginase but discontinue drug due to toxicity
are eligible
- Patients with prior allergies to pegaspargase that are clinically significant
are eligible provided Erwinia L-asparaginase can be substituted
- Patients who relapse on therapy other than standard ALL maintenance therapy must have
fully recovered from the acute toxic effects of all prior chemotherapy,
immunotherapy, or radiotherapy prior to entering this study
- At least 14 days since the completion of cytotoxic therapy with the exception of
hydroxyurea, which is permitted up to 24 hours prior to the start of protocol
therapy
- At least 7 days since the completion of therapy with a biologic agent or donor
lymphocyte infusions (DLI); for agents that have known adverse events occurring
beyond 7 days after administration, this period must be extended beyond the time
during which adverse events are known to occur
- Stem cell transplant or rescue: no evidence of active graft-vs-host disease
(GVHD) and ≥ 4 months must have elapsed; must not be receiving GVHD prophylaxis
- No prior cumulative anthracycline exposure > 400 mg/m²
- No prior bortezomib or other proteasome inhibitors
- No prior reinduction attempts or treatment for prior extramedullary relapse
- Patients with primary induction failure are not eligible
- No concurrent anticonvulsants known to activate the cytochrome p450 system (e.g.,
phenytoin, carbamazepine, and phenobarbital)
- Concurrent benzodiazepines or gabapentin allowed
- No concurrent corticosteroids (including steroids as antiemetics) except as treatment
or prophylaxis for anaphylactic reactions OR treatment for pulmonary toxicity
- No other concurrent anticancer chemotherapy or immunomodulating agents
- Patients who relapse while receiving standard ALL maintenance chemotherapy will not
be required to have a waiting period before entry onto this study
We found this trial at
157
sites
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Children's Hospital of Alabama Children
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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Medical City Dallas Hospital If you have concerns for your health, that of a family...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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Lee Memorial Health System Our origins can be traced to the Fall of 1916 when...
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
616.391.9000
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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Greenville Hospital Cancer Center Greenville Health System (GHS) is a public not-for-profit academic healthcare delivery...
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Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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Covenant Children's Hospital Every child is different. And when they're sick or injured, they deserve...
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9300 Valley Children's Pl
Madera, California 93720
Madera, California 93720
(559) 353-3000
Children's Hospital Central California The Children's Hospital Central California is a not-for-profit, state-of-the-art children’s hospital...
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1475 N.W. 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
305-243-1000
University of Miami Miller School of Medicine-Sylvester Cancer Center Sylvester Comprehensive Cancer Center integrates all...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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747 52nd St
Oakland, California 94609
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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The Florida Hospital Florida Hospital is one of the country’s largest not-for-profit health care providers...
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1717 South Orange Avenue # 100
Orlando, Florida 32806
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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1400 South Orange Avenue
Orlando, Florida 32806
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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280 W MacArthur Blvd,
Sacramento, California 94611
Sacramento, California 94611
(510) 752-1000
Kaiser Permanente Medical Center - Oakland The East Bay area, home of the flagship Oakland...
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All Children's Hospital All Children's Hospital provides expert pediatric care for children and families from...
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7700 Floyd Curl Dr
San Antonio, Texas 78229
San Antonio, Texas 78229
(210) 575-7000
Methodist Children's Hospital of South Texas Methodist Children
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Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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750 East Adams Street
Syracuse, New York 13210
Syracuse, New York 13210
(315) 464-5540
State University of New York - Upstate Medical University SUNY Upstate Medical University in Syracuse,...
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Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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C S Mott Children's Hospital Behind the doors of C.S. Mott Children's Hospital there exist...
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Mission Hospitals Mission Hospital, the flagship hospital of Mission Health, has been committed to improving...
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Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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3110 MacCorkle Ave. S.E.
Charleston, West Virginia 25304
Charleston, West Virginia 25304
304-347-1206
West Virginia University Health Sciences Center - Charleston The West Virginia University Robert C. Byrd...
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Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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5841 S Maryland Ave
Chicago, Illinois 60637
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Univ of Illinois A major research university in the heart of one of the world's...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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University Of Missouri-Columbia The University of Missouri was founded in 1839 in Columbia, Mo., as...
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Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Dayton Children's - Dayton We have more than 290,000 reasons to make sure the care...
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Denver, Colorado 80218
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Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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4760 Sunset Blvd
Downey, California 90027
Downey, California 90027
(323) 783-6151
Southern California Permanente Medical Group We
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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900 West Faris Rd.
Greenville, South Carolina 29605
Greenville, South Carolina 29605
(864)455-8898
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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1005 Joe DiMaggio Drive
Hollywood, Florida 33021
Hollywood, Florida 33021
954-265-JDCH (5324)
Memorial Healthcare System - Joe DiMaggio Children's Hospital Since its inception in 1953, Memorial Healthcare...
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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2001 W 86th St
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
(317) 338-2345
Saint Vincent Hospital and Health Services At St.Vincent Indianapolis, everything we do begins with a...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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