Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors



Status:Completed
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 21
Updated:8/31/2018
Start Date:November 5, 2007
End Date:June 30, 2018

Use our guide to learn which trials are right for you!

Treatment of Recurrent or Resistant Pediatric Malignant Germ Cell Tumors With Paclitaxel, Ifosfamide and Carboplatin

This phase II trial is studying how well giving combination chemotherapy works in treating
young patients with recurrent or resistant malignant germ cell tumors. Drugs used in
chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PRIMARY OBJECTIVES:

I. Determine the response rate in pediatric patients with recurrent or resistant malignant
germ cell tumors (GCT) treated with paclitaxel, ifosfamide, and carboplatin.

SECONDARY OBJECTIVES:

I. Determine the toxicity of this regimen in these patients. II. To Collect tissue for the
tumor bank that will aid in the identification of the biological characteristics of recurrent
GCT.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and
ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim
(G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment
repeats every 21 days for 2 courses in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

Inclusion Criteria:

- Histologically confirmed (at original diagnosis) extracranial germ cell tumor (GCT)
containing 1 of the following malignant elements:

- Yolk sac tumor (endodermal sinus tumor)

- Choriocarcinoma

- Embryonal carcinoma

- Meets 1 of the following disease criteria:

- Recurrent malignant disease

- Chemotherapy-resistant disease

- Relapsed disease

- Disease refractory to conventional therapy

- Measurable disease

- Must have received a prior first-line chemotherapy regimen that included cisplatin

- Patients with tumor marker (AFP and/or BHCG) elevation alone or bone scan findings
alone are not eligible*

- Patients with immature teratoma (any grade), germinoma, sex-cord stromal tumors, or
recurrent GCT previously treated with surgery alone are not eligible

- Karnofsky performance status (PS) 50-100% (age > 16 years) OR Lansky PS 50-100% (age ≤
16 years) OR ECOG PS 0-2

- Life expectancy ≥ 8 weeks

- Absolute neutrophil count ≥ 750/mm³

- Platelet count ≥ 75,000/mm³ (transfusion independent)

- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
creatinine normal based on age/gender, as defined by the following:

- ≤ 0.4 mg/dL (1 month to < 6 months of age)

- ≤ 0.5 mg/dL (6 months to < 1 year of age)

- ≤ 0.6 mg/dL (1 to < 2 years of age)

- ≤ 0.8 mg/dL (2 to < 6 years of age)

- ≤ 1.0 mg/dL (6 to < 10 years of age)

- ≤ 1.2 mg/dL (10 to < 13 years of age)

- ≤ 1.4 mg/dL (13 to ≥ 16 years of age) (female)

- ≤ 1.5 mg/dL (13 to < 16 years of age) (male)

- ≤ 1.7 mg/dL (≥ 16 years of age) (male)

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

- ALT < 2.5 times ULN for age

- Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by gated
radionuclide study

- No dyspnea at rest

- No exercise intolerance

- Pulse oximetry > 94% (if there is clinical indication for determination)

- Patients with seizure disorder are eligible provided they are on non-enzyme inducing
anticonvulsants and seizures are well controlled

- No CNS toxicity > grade 2

- No active graft-versus-host disease

- No allergy to Cremophor EL or castor oil

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other concurrent chemotherapy or immunomodulating agents

- Recovered from prior chemotherapy, immunotherapy, or radiotherapy

- At least 1 week since prior growth factors (2 weeks for pegfilgrastim)

- At least 1 week since prior biologic therapy

- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea)

- At least 2 weeks since prior local palliative radiotherapy (i.e., small port)

- At least 6 months since prior craniospinal radiotherapy or radiotherapy to ≥ 50% of
pelvis

- At least 6 weeks since other prior substantial bone marrow radiotherapy

- At least 6 months since prior allogeneic stem cell transplantation

- Concurrent radiotherapy to localized painful lesions allowed provided at least 1
measurable lesion is not irradiated
We found this trial at
86
sites
Honolulu, Hawaii 96813
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
9981 S Healthpark Dr # 465
Fort Myers, Florida 33908
239-343-5000
Lee Memorial Health System Our origins can be traced to the Fall of 1916 when...
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
?
mi
from
Hartford, CT
Click here to add this to my saved trials
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
4015 22nd Place
Lubbock, Texas 79410
806-725-0000
Covenant Children's Hospital Every child is different. And when they're sick or injured, they deserve...
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
?
mi
from
Memphis, TN
Click here to add this to my saved trials
601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
(309) 624-4945
Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...
?
mi
from
Peoria, IL
Click here to add this to my saved trials
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Methodist Children's Hospital of South Texas Methodist Children
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
?
mi
from
Wilmington, DE
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
?
mi
from
Boston, MA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
3110 MacCorkle Avenue Southeast
Charleston, West Virginia 25304
?
mi
from
Charleston, WV
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60614
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Univ of Illinois A major research university in the heart of one of the world's...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Dayton, Ohio 45404
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
9333 Imperial Highway
Downey, California 90242
?
mi
from
Downey, CA
Click here to add this to my saved trials
801 Broadway North
Fargo, North Dakota 58122
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Farmington, Connecticut 06030
?
mi
from
Farmington, CT
Click here to add this to my saved trials
801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
?
mi
from
Hershey, PA
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
New Orleans, Louisiana 70118
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Oak Lawn, Illinois 60453
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
703 Main Street
Paterson, New Jersey 07503
973.754.2000
Saint Joseph's Regional Medical Center Rich in history, St. Joseph's Healthcare System has evolved from...
?
mi
from
Paterson, NJ
Click here to add this to my saved trials
Pensacola, Florida 32504
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Perth, Western Australia
?
mi
from
Perth,
Click here to add this to my saved trials
Roanoke, Virginia 24014
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
99 Beauvoir Avenue
Summit, New Jersey 07902
(908) 522-2000
Overlook Hospital Atlantic Health System
?
mi
from
Summit, NJ
Click here to add this to my saved trials
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
?
mi
from
Washington,
Click here to add this to my saved trials
901 45th St
West Palm Beach, Florida 33407
(561) 844-6300
Saint Mary's Hospital Our team of dedicated physicians, nurses and staff offer a broad spectrum...
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials