Clinical trial NCT00002488: Combination Chemotherapy in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma Who Have Not Responded to Anthracycline-Containing Combination Chemotherapy
Official title: INTENSIFICATION WITH HIGH DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN FOR INTERMEDIATE OR HIGH GRADE LYMPHOMA PATIENTS WHO FAILED PRIMARY COMBINATION CHEMOTHERAPY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lymphoma
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-08-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide, etoposide, and cisplatin in treating patients with intermediate or high-grade non-Hodgkin's lymphoma who have relapsed following or are resistant to anthracycline-containing primary combination chemotherapy.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Center - General Division
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre - Civic Campus
state: Ontario
Study officials:
affiliation: Ottawa Regional Cancer Centre
name: Jonathan C. Yau, MD
role: STUDY_CHAIR
References: