Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma
Status: | Recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any - 21 |
Updated: | 1/9/2019 |
Start Date: | June 5, 2009 |
End Date: | December 2021 |
Contact: | Monika Metzger, MD |
Email: | referralinfo@stjude.org |
Phone: | 866-278-5833 |
Reduced Duration Stanford V Chemotherapy With or Without Low-Dose Tailored-Field Radiation Therapy For Favorable Risk Pediatric Hodgkin Lymphoma
This phase II trial is studying how well combination chemotherapy with or without radiation
therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in
chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride,
vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving
more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy
uses high-energy x-rays to kill cancer cells for those patients that still had residual
cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may
kill more cancer cells and allow doctors to save the part of the body where the cancer
started.
therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in
chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride,
vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving
more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy
uses high-energy x-rays to kill cancer cells for those patients that still had residual
cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may
kill more cancer cells and allow doctors to save the part of the body where the cancer
started.
Patients receive doxorubicin hydrochloride intravenously (IV) and vinblastine IV on day 1 of
weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5; vincristine
sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on day 1 of weeks
3 and 7; and prednisone orally (PO) three times daily every other day for 8 weeks. Two to 3
weeks after all chemotherapy is given, patients not achieving a complete response undergo
radiation therapy to individual nodal sites (tailored fields).
PRIMARY OBJECTIVES:
1. To increase the complete response rate of favorable risk patients (excluding all patients
with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at
least 20% compared to favorable risk patients on HOD 99 after 8 weeks vincristine,
doxorubicin hydrochloride, methotrexate and prednisone (VAMP).
SECONDARY OBJECTIVES:
1. To estimate the disease failure rate within the radiation fields.
2. To examine patterns of treatment failure for children treated with low dose tailored
field radiation therapy.
3. To describe acute hematologic and infectious toxicities as they relate to transfusion
requirements, growth factor support, episodes of febrile neutropenia, and
hospitalizations, according to the National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) version 3.0.
4. To compare the survival distributions (event-free and overall) and cumulative incidence
of local failure and toxicities of favorable risk patients treated with 8 weeks of
Stanford V chemotherapy and low-dose tailored-field radiation to those on the favorable
risk group of the HOD 99 study that received VAMP and low-dose involved-field radiation.
5. To compare the survival distributions between patients that will not be prescribed
radiotherapy after 8 weeks Stanford V and those patients on HOD 99 that did not receive
radiotherapy after VAMP.
6. To estimate the event-free survival distributions of favorable risk patients treated
with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy
plus low dose tailored field radiation.
weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5; vincristine
sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on day 1 of weeks
3 and 7; and prednisone orally (PO) three times daily every other day for 8 weeks. Two to 3
weeks after all chemotherapy is given, patients not achieving a complete response undergo
radiation therapy to individual nodal sites (tailored fields).
PRIMARY OBJECTIVES:
1. To increase the complete response rate of favorable risk patients (excluding all patients
with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at
least 20% compared to favorable risk patients on HOD 99 after 8 weeks vincristine,
doxorubicin hydrochloride, methotrexate and prednisone (VAMP).
SECONDARY OBJECTIVES:
1. To estimate the disease failure rate within the radiation fields.
2. To examine patterns of treatment failure for children treated with low dose tailored
field radiation therapy.
3. To describe acute hematologic and infectious toxicities as they relate to transfusion
requirements, growth factor support, episodes of febrile neutropenia, and
hospitalizations, according to the National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) version 3.0.
4. To compare the survival distributions (event-free and overall) and cumulative incidence
of local failure and toxicities of favorable risk patients treated with 8 weeks of
Stanford V chemotherapy and low-dose tailored-field radiation to those on the favorable
risk group of the HOD 99 study that received VAMP and low-dose involved-field radiation.
5. To compare the survival distributions between patients that will not be prescribed
radiotherapy after 8 weeks Stanford V and those patients on HOD 99 that did not receive
radiotherapy after VAMP.
6. To estimate the event-free survival distributions of favorable risk patients treated
with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy
plus low dose tailored field radiation.
Inclusion Criteria:
- Histologically confirmed, previously untreated Hodgkin lymphoma.
- Age: Participants must be 21 years of age or younger
- Stage must be classified as one of the following:
Ann Arbor stage IA or IIA with:
- Non-bulky mediastinal disease (< 33% mediastinal to thoracic ratio on CXR)
- < 3 nodal regions involved on the same side of the diaphragm
- No "E" lesion
- Female patients who are post-menarchal must have a negative pregnancy test. Patients
of reproductive potential must agree to use an effective contraceptive method.
- Signed informed consent
- If re-evaluation of a patient's disease shows intermediate risk features, the patient
will be removed from the HOD08.
Exclusion Criteria:
- Intermediate or High risk disease, defined as Stage IB, any III or IV or IA/IIA with
"E" lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy
We found this trial at
7
sites
100 Campus Drive
Scarborough, Maine 04074
Scarborough, Maine 04074
Principal Investigator: Eric Larsen, MD
Phone: 207-396-7565
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262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Monika Metzger, MD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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3020 Childrens way
San Diego, California 92123
San Diego, California 92123
(858) 576-1700
Principal Investigator: Dennis Kuo, MD
Phone: 858-966-5811
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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55 Fruit St
Boston, Massachusetts 02114
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Alison Friedmann, MD
Phone: 617-726-2737
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, Massachusetts 02115
Principal Investigator: Amy Billett, MD
Phone: 617-632-5640
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Palo Alto, California 94304
Principal Investigator: Michael Link, MD
Phone: 650-495-8815
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555 University Avenue
Toronto, Ontario M5G 1X8
Toronto, Ontario M5G 1X8
Principal Investigator: Angela Punnett, MD
Phone: 416-813-5934
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