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Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
Not Recruiting
Trial ID: NCT00025259
Purpose
This randomized phase III trial is studying different chemotherapy regimens given with or
without radiation therapy to compare how well they work in treating children with newly
diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer
cells from dividing so they stop growing or die. Giving the drugs in different combinations
may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells.
It is not yet known if chemotherapy is more effective with or without additional chemotherapy
and/or radiation therapy in treating Hodgkin's disease.
Official Title
A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all
histologies) are eligible for this protocol if they meet the following clinical stage
guidelines:
- All Stage IB regardless of bulk disease
- All Stage IIB regardless of bulk disease
- Stage IA only with bulk disease
- Stage IIA only with bulk disease
- All Stage IAE, IIAE regardless of bulk disease
- All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease
- All Stage IVA, IVAE regardless of bulk disease
- May not be staged by laparotomy alone
- Surgically staged patients must also have presurgical staging
- Bilirubin no greater than 1.5 times normal
- SGOT or SGPT less than 2.5 times normal
- Creatinine no greater than 1.5 times normal
- Creatinine clearance greater than 40 mL/min
- Radioisotope glomerular filtration rate greater than 70 mL/min
- Shortening fraction at least 27% by echocardiogram
- Ejection fraction at least 50% by MUGA
- No pathologic prolongation of QTc interval on 12-lead electrocardiogram
- FEV_1/FVC greater than 60% by pulmonary function test
- Pulse oximetry greater than 94%
- No evidence of dyspnea at rest
- No exercise intolerance
- Adequate venous access
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior chemotherapy
- At least 1 month since prior corticosteroids except prednisone for respiratory
distress
- No prior radiotherapy
Intervention(s):
biological: bleomycin sulfate
biological: filgrastim
drug: cisplatin
drug: cyclophosphamide
drug: cytarabine
drug: dexamethasone
drug: doxorubicin hydrochloride
drug: etoposide
drug: prednisone
radiation: Involved-Field Radiation Therapy
drug: Vincristine Sulfate Liposome
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535