Combination Chemotherapy in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's Lymphoma Who Have Not Responded to Anthracycline-Containing Combination Chemotherapy

Lymphoma Clinical Trial

Official title:

INTENSIFICATION WITH HIGH DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN FOR INTERMEDIATE OR HIGH GRADE LYMPHOMA PATIENTS WHO FAILED PRIMARY COMBINATION CHEMOTHERAPY

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002488
• Other study ID #: CDR0000077375
• Secondary ID: CAN-OTT-9106NCI-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 16, 2013
• Start date: December 1991

Study information

• Verified date: April 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• cisplatin

• cyclophosphamide

• etoposide

Locations

Country	Name	City	State
Canada	Ottawa Regional Cancer Center - General Division	Ottawa	Ontario
Canada	Ottawa Regional Cancer Centre - Civic Campus	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Regional Cancer Centre

Country where clinical trial is conducted

Canada,