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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049439
• Other study ID #: CWRU2498
• Secondary ID: P30CA043703CWRU-
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2002
• Last updated: June 9, 2010
• Start date: March 1998
• Est. completion date: February 2008

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2008
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of acquired immune deficiency syndrome

• Histologically confirmed stage I, II, III, or IV intermediate- or high-grade non-Hodgkin's lymphoma

• B-cell, T-cell, or indeterminate immunologic phenotype

• Measurable or evaluable disease

• No clinical, radiographic, or cytological evidence of CNS parenchymal, vitreal, or leptomeningeal involvement by lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

• 18 and over (in the United States)

• 16 and over (in Africa)

Performance status

• ECOG 0-3

Life expectancy

• At least 6 weeks

Hematopoietic

• WBC at least 1,500/mm3

• Platelet count at least 50,000/mm3

Hepatic

• Bilirubin no greater than 3.0 mg/dL

Renal

• Creatinine no greater than 3.0 mg/dL

Other

• Concurrent active infection for which patient is receiving treatment allowed provided clinical status is stable

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for lymphoma

Endocrine therapy

• Not specified

Radiotherapy

• Prior radiotherapy for stage I or II disease allowed provided there is documentation of disease progression

Surgery

• Not specified

Other

• Concurrent antiretroviral therapy (except zidovudine) allowed

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

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.
• etoposide
Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
• 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.
• 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.

Locations

Country	Name	City	State
Kenya	University of Nairobi College of Health Sciences	Nairobi
Uganda	Uganda Cancer Institute	Kampala
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Kenya,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease response		Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.	No
Secondary	Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory		days 1 and 2 of courses 1 and 2 and on day 84	No