Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma

In brief

RATIONALE: 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 more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy and radiation therapy with an autologous stem cell transplant, using peripheral stem cells or bone marrow from the patient, may allow more chemotherapy to be given so that more cancer cells are killed. Giving combination chemotherapy together with radiation therapy before an autologous stem cell transplant may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well combination chemotherapy and radiation therapy work in treating patients who are undergoing an autologous stem cell transplant for relapsed or refractory Hodgkin's lymphoma.

Key facts

Study ID

NCT00255723

Run by

Memorial Sloan Kettering Cancer Center

People needed

98

Starts

2004-04-01

Expected to finish

2012-07-01

Last updated by the study team

2016-02-01

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic diagnosis of Classical Hodgkin's Lymphoma. Lymphocyte predominant histology will be excluded.
• Primary refractory or relapsed disease proven by biopsy or fine needle aspiration (cytology) of an involved site
• Failure of doxorubicin or nitrogen mustard containing front-line therapy
• 18F-fluorodeoxyglucose-PET scan demonstrating PET avid disease
• Cardiac ejection fraction of greater than 45%, measured since last chemotherapy.
• Adjusted diffusing capacity of greater than 50% on pulmonary function testing, measured since last chemotherapy
• Serum creatinine < than or = to 1.5 mg/dl; if creatinine >1.5 mg/dl then the measured 12- or 24-hour creatinine clearance must be >60 ml/minute.
• ANC>1000/μl and Platelets>50,000/μl
• Total bilirubin < than or = to 2.0 mg/dl in the absence of a history of Gilbert's disease.
• Females of childbearing age must be on an acceptable form of birth control.
• Age between 18 and 72
• HIV I and II negative.
• Patients or their guardians must be capable of providing informed consent.

You may not qualify if…

• Histology for Lymphocyte predominant subtype Hodgkin's Lymphoma
• Prior treatment with carboplatin, cisplatin, ifosfamide, gemcitabine, or vinorelbine
• Hepatitis B surface antigen positive.
• Known pregnancy or breast-feeding.
• Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, will preclude administering chemotherapy safely.
• History of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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