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.

Sponsored by: Ottawa Regional Cancer Centre
Information provided by: National Cancer Institute (NCI)

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

Further Study Details: 

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

Study chairs or principal investigators

Jonathan C. Yau,  Study Chair,  Ottawa Regional Cancer Centre   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000077375; CAN-OTT-9106; NCI-V92-0013
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 9, 2005

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