Adult Hodgkin's Lymphoma |
|
|
Clinical Trial: Combination Chemotherapy in Treating Patients With Intermediate- or High-Grade Non-Hodgkin's Lymphoma Who Have Not Responded to Anthracycline-Containing Combination Chemotherapy
This study is no longer recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| recurrent adult lymphoblastic lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent grade III follicular large cell lymphoma recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma | Drug: cisplatin Drug: cyclophosphamide Drug: etoposide | Phase II |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Intensification with High-Dose CTX/VP-16/CDDP in Patients with Intermediate- or High-Grade non-Hodgkin's Lymphoma Who Have Failed Primary Anthracycline-Containing Combination Chemotherapy
Study start: December 1991
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.
PROTOCOL 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
Ages Eligible for Study: 18 Years - 64 Years
Criteria
PROTOCOL ENTRY 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
--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
--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
Location Information
Canada, Ontario
Ottawa Regional Cancer Center - General Division, Ottawa, Ontario, K1H 8L6, Canada
Ottawa Regional Cancer Centre - Civic Campus, Ottawa, Ontario, K1Y 4K7, Canada
Jonathan C. Yau, Study Chair, Ottawa Regional Cancer Centre
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: August 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002488
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Not Signed In -


