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Altretamine and Etoposide in Treating Patients With HIV-Related Cancer



Altretamine and Etoposide in Treating Patients With HIV-Related Cancer

For Condition: epidemic Kaposi's sarcoma,recurrent Kaposi's sarcoma,AIDS-related peripheral/systemic lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Roswell Park Cancer Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of altretamine plus etoposide in treating patients with HIV -related cancer.
Details: OBJECTIVES: I. Determine toxic effects of repeated courses of altretamine plus etoposide at the maximum tolerated dose (MTD). II. Assess the response duration and time to progression at the MTD in the treatment of HIV malignancies. III. Assess the efficacy of the combination on the immune systems of these individuals. IV. Assess the effect of the combination on the quality of life in these individuals. PROTOCOL OUTLINE: Patients are treated with altretamine (HMM) and etoposide for 2 weeks followed by 2 weeks of rest. This cycle is repeated for a minimum of 2 and a maximum of 6 cycles if there is no progression of disease. Patients who are in complete remission receive an additional 2 cycles (total of 8 cycles). There are different cohorts consisting of 4 patients each in which toxic effects will be evaluated with escalating doses of this combination. The MTD is defined as the dose level immediately below that at which half of the patients experience dose-limiting toxicity. Patients are followed for relapse and survival. PROJECTED ACCRUAL: 20 patients will be accrued in 2 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA --Disease Characteristics-- - Documented HIV antibody positive - Histologically confirmed, by biopsy, non-Hodgkin's lymphoma that is in complete remission or stable/partial remission for a minimal period of one month AND/OR Histologically confirmed, by biopsy, Kaposi's sarcoma without stable disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Patients with concurrent antiretroviral therapy should be on a stable dose of that therapy for at least one month prior to entry; No concurrent cytotoxic chemotherapy - Endocrine therapy: No concurrent hormone therapy - Radiotherapy: No concurrent radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Hematopoietic: Absolute neutrophil count at least 500/mm3; Platelet count greater than 25,000/mm3 (unless secondary to lymphoma) - Hepatic: Transaminases less than 5 times upper limit of normal AND Bilirubin less than 2.0, unless secondary to lymphoma - Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min; Dose reduction of 21% if creatinine clearance 10-50 mL/min; Dose reduction of 50% if creatinine clearance less than 10 mL/min - Cardiovascular: No active cardiac arrhythmia or angina - Pulmonary: Must exclude Pneumocystis carinii pneumonia if there is any suspicion of infection - Other: No uncontrolled infections; Not pregnant or nursing; Adequate contraception for fertile patients
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
LawrenceLeichman,  Study Chair,  Roswell Park Cancer Institute

Roswell Park Cancer Institute
Buffalo,  New York,  14263-0001
United States
 


Additional Information:
Study ID Numbers:  CDR0000065373;  RPCI-DS-95-05,NCI-G97-1165
Study Start Date: July 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002936

Other Aids-Related Peripheral/systemic Lymphoma Studies:
1. Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection

2. Flavopiridol in Treating Patients With HIV-Related Kaposi's Sarcoma

3. Altretamine and Etoposide in Treating Patients With HIV-Related Cancer

4. BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma

5. Paclitaxel in Treating Patients With AIDS-Related Kaposi's Sarcoma

Related Studies:

Other AIDS-related peripheral/systemic lymphoma Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials

Altretamine and Etoposide in Treating Patients With HIV-Related Cancer
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