Viewing Study NCT00002488



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Last Modification Date: 2024-10-26 @ 9:03 AM
Study NCT ID: NCT00002488
Status: UNKNOWN
Last Update Posted: 2013-09-17
First Post: 1999-11-01

Brief Title: Combination Chemotherapy in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkins Lymphoma Who Have Not Responded to Anthracycline-Containing Combination Chemotherapy
Sponsor: Ottawa Regional Cancer Centre
Organization: National Cancer Institute NCI

Study Overview

Official Title: INTENSIFICATION WITH HIGH DOSE CYCLOPHOSPHAMIDE ETOPOSIDE AND CISPLATIN FOR INTERMEDIATE OR HIGH GRADE LYMPHOMA PATIENTS WHO FAILED PRIMARY COMBINATION CHEMOTHERAPY
Status: UNKNOWN
Status Verified Date: 2000-04
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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-Hodgkins lymphoma who have relapsed following or are resistant to anthracycline-containing primary combination chemotherapy
Detailed Description: OBJECTIVES I Determine the efficacy of high-dose cyclophosphamideetoposidecisplatin in patients with intermediate- or high-grade non-Hodgkins lymphoma who have failed primary combination chemotherapy but still respond to conventional-dose DHAP dexamethasonecytarabinecisplatin 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-V92-0013 None None None
CAN-OTT-9106 None None None