NCT00049439

Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma

Dose-Modified Oral Combination Chemotherapy In Patients With Aids-Related Non-Hodgkin's Lymphoma In The United States And Africa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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 combining lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients who have AIDS-related non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	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.
DRUG	cyclophosphamide	Oral cyclophosphamide on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
DRUG	etoposide	Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
DRUG	lomustine	Oral lomustine on day 1 (course 1 only). Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
DRUG	procarbazine hydrochloride	Oral procarbazine on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

Timeline

• Start date: 1998-03-01
• Primary completion: 2005-10-01
• Completion: 2008-02-01
• First posted: 2003-01-27
• Last updated: 2010-06-11

Locations

4 sites across 3 countries: United States, Kenya, Uganda