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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma

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



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

For Condition: AIDS-related small noncleaved cell lymphoma,AIDS-related immunoblastic large cell lymphoma,AIDS-related diffuse small cleaved cell lymphoma,AIDS-related diffuse mixed cell lymphoma,AIDS-related lymphoblastic lymphoma,AIDS-related diffuse large cell lymphoma
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ScotRemick,  Study Chair,  Ireland Cancer Center

Uganda Cancer Institute *Recruiting*
Kampala,  , 
Uganda
Recruiting Edward  Katongole-Mbidde 256 41 540410

Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Nalini  Janakiraman 313-876-3820

Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Gwen  Nichols 212-305-5705

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106-5065
United States
Recruiting Scot  Remick 216-844-1196

University of Nairobi College of Health Sciences *Recruiting*
Nairobi,  , 
Kenya
Recruiting Walter  Mwanda 254 2 222080


Additional Information:
Study ID Numbers:
  CDR0000258098;  CWRU-2498,CWRU-029828J,NCI-G02-2126
Study Start Date: 
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049439

Other Aids-Related Diffuse Small Cleaved Cell Lymphoma Studies:
1. Combination Chemotherapy and Rituximab in Treating Patients With HIV-Associated Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma or High-Risk Stage I Non-Hodgkin's Lymphoma

2. Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma

3. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Previously Untreated HIV-Associated Non-Hodgkin's Lymphoma

4. Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma

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

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