Overview
Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Bone marrow transplantation may allow doctors to give higher doses of radiation therapy and chemotherapy and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of high-dose etoposide and cyclophosphamide plus total-body irradiation followed by bone marrow transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
St. Luke's Medical CenterTreatments:
BB 1101
Cisplatin
Cyclophosphamide
Cytarabine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Etoposide
Etoposide phosphate
Criteria
DISEASE CHARACTERISTICS: Histologically proven or unequivocal radiologic evidence ofnon-Hodgkin's lymphoma that has relapsed or is refractory after first-line chemotherapy
Unequivocal radiologic evidence of relapse defined as the presence of enlarged (at least 2
cm diameter) lymph nodes by CT scan or lymphangiogram Biopsy of accessible lymph nodes to
confirm relapse encouraged Low-, intermediate-, or high-grade disease Normal bilateral bone
marrow biopsy at time of bone marrow collection required (cellularity at least 20% and no
histologic evidence of tumor) History of marrow involvement allowed if present marrow is
histologically normal No disease progression in a previously irradiated site A new
classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The
terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of
"low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former
terminology.
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: CALGB 0-2 Karnofsky 70-100%
Life expectancy: More than 2 months Hematopoietic: Neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3 times normal SGOT and
SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal Hepatitis B
surface antigen negative Renal: Creatinine normal Creatinine clearance at least 60 mL/min
Cardiovascular: Cardiac ejection fraction normal by MUGA scan No uncontrolled or severe
cardiovascular disease, including the following: Myocardial infarction within the past 6
months Congestive heart failure Symptomatic angina (despite optimal medical management)
Life-threatening arrhythmia or hypertension Pulmonary: Pulmonary function tests (DLCO and
spirometry) greater than 60% predicted Other: HIV negative No serious organ dysfunction
(unless caused by lymphoma) No active bacterial, viral, or fungal infection No active
peptic ulcer disease No uncontrolled diabetes mellitus No other malignancy except
curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin
cancer No other serious medical or psychiatric illness that would preclude study Not
pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Prior nitrosourea allowed if cumulative dose no more than 600 mg/m2 Prior
bleomycin allowed if cumulative dose no more than 300 units/m2 Prior doxorubicin allowed if
cumulative dose no more than 450 mg/m2 No prior high-dose etoposide (more than 1,800 mg/m2)
No prior high-dose cyclophosphamide (more than 100 mg/kg) No chemotherapy within 4 weeks
(no melphalan, nitrosourea, or mitomycin within 6 weeks) prior to bone marrow collection No
prior salvage therapy Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics No prior radiotherapy to liver or lung Prior other radiotherapy allowed if
doses do not exceed the following limits: 1,400 cGy to the mediastinum 1,400 cGy to the
whole abdomen 4,000 cGy to the CNS Surgery: Not specified