Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00049439|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 11, 2010
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 combining lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients who have AIDS-related non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: filgrastim Drug: cyclophosphamide Drug: etoposide Drug: lomustine Drug: procarbazine hydrochloride||Phase 2|
- Determine the objective response rate, response duration, and survival of patients with AIDS-related non-Hodgkin's lymphoma treated with lomustine, etoposide, cyclophosphamide, and procarbazine.
- Determine the feasibility of this regimen in these patients.
- Determine the clinical toxicity of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
- Determine the impact of this regimen on the underlying HIV infection in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral lomustine on day 1 (course 1 only), oral etoposide on days 1-3, and oral cyclophosphamide and oral procarbazine on days 22-26. Patients may also receive filgrastim (G-CSF) subcutaneously on days 5-21 and 28-42. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on days 1 and 22 of each course, at day 84, and then every 3 months for 1 year.
Patients are followed at day 84 and then every 3 months.
PROJECTED ACCRUAL: A total of 66 patients (22 in the United States and 44 in Africa) will be accrued for this study within 3-4 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa|
|Study Start Date :||March 1998|
|Actual Primary Completion Date :||October 2005|
|Actual Study Completion Date :||February 2008|
- Disease response [ Time Frame: Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. ]
- Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory [ Time Frame: days 1 and 2 of courses 1 and 2 and on day 84 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049439
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|University of Nairobi College of Health Sciences|
|Uganda Cancer Institute|
|Study Chair:||Scot C. Remick, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|