Status:
COMPLETED
Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
OBJECTIVES: Primary * Determine whether event-free survival of patients with low to high-intermediate risk, relapsed or refractory Hodgkin's lymphoma can be improved when treated with cytoreductive ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00255723
Start Date
April 1 2004
End Date
July 1 2012
Last Update
February 1 2016
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065