INTENSIFICATION WITH HIGH DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN FOR INTERMEDIATE OR HIGH GRADE LYMPHOMA PATIENTS WHO FAILED PRIMARY COMBINATION CHEMOTHERAPY
18 Years
64 Years
Both
Lymphoma
Trial Information
INTENSIFICATION WITH HIGH DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN FOR INTERMEDIATE OR HIGH GRADE LYMPHOMA PATIENTS WHO FAILED PRIMARY COMBINATION CHEMOTHERAPY
OBJECTIVES: I. Determine the efficacy of high-dose cyclophosphamide/etoposide/cisplatin in
patients with intermediate- or high-grade non-Hodgkin's lymphoma who have failed primary
combination chemotherapy but still respond to conventional-dose DHAP
(dexamethasone/cytarabine/cisplatin) and are not candidates for bone marrow transplantation.
II. Determine the toxicity of the intensification chemotherapy regimen in this group of
patients.
OUTLINE: Nonrandomized study. 3-Drug Combination Chemotherapy. CVP: Cyclophosphamide, CTX,
NSC-26271; Etoposide, VP-16, NSC-141540; Cisplatin, CDDP, NSC-119875.
PROJECTED ACCRUAL: If at least 1 CR is seen in the first 6 patients, an estimated maximum of
20 patients will be enrolled. If 3 or more of the first 10 patients (or 25% of the study
population thereafter) die within the first 35 days of treatment from causes unrelated to
tumor progression, the study will be terminated.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intermediate- or high-grade non-
Hodgkin's lymphoma of the following histologies: Follicular, predominantly large cell
Diffuse small cleaved cell Diffuse mixed, small and large cell Diffuse large cell Large
cell, immunoblastic Lymphoblastic Small noncleaved cell Disease has relapsed following or
is resistant to primary anthracycline-containing combination chemotherapy Objective
response to salvage DHAP chemotherapy required Ineligible for bone marrow transplantation
PATIENT CHARACTERISTICS: Age: 18 to 64 Performance status: Zubrod 0 or 1 Hematopoietic:
ANC at least 1,500 Platelets at least 140,000 Hb at least 10 g/dl Hepatic: Bilirubin less
than 1.5 mg/dl (26 micromoles/liter) SGOT less than 4 x normal Renal: Creatinine less than
1.5 mg/dl (133 micromoles/liter) Cardiovascular: LVEF greater than 50% No life-threatening
arrhythmia by EKG No uncontrolled hypertension Pulmonary: FEV, FVC, and DLCO greater than
50% of predicted Other: No uncontrolled diabetes No other uncontrolled medical condition
No history of second malignancy except: Nonmelanomatous skin cancer Carcinoma in situ
Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior
anthracycline-containing combination chemotherapy required Prior salvage DHAP chemotherapy
required Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Jonathan C. Yau, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ottawa Regional Cancer Centre
Authority:
United States: Federal Government
Study ID:
CDR0000077375
NCT ID:
NCT00002488
Start Date:
December 1991
Completion Date:
Related Keywords:
- Lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
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