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

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

cisplatin

cyclophosphamide

etoposide

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ottawa Regional Cancer Center - General Division
Ottawa Regional Cancer Centre - Civic Campus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002488

First Posted

November 1, 1999

Last Updated

September 16, 2013

Sponsor

Ottawa Regional Cancer Centre

1. Study Identification

Unique Protocol Identification Number

NCT00002488

Brief Title

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

2. Study Status

Record Verification Date

April 2000

Overall Recruitment Status

Unknown status

Study Start Date

December 1991 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Ottawa Regional Cancer Centre

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

etoposide

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan C. Yau, MD

Organizational Affiliation

Ottawa Regional Cancer Centre

Official's Role

Study Chair

Facility Information:

Facility Name

Ottawa Regional Cancer Center - General Division

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Ottawa Regional Cancer Centre - Civic Campus

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4K7

Country

Canada

Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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