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Altretamine and Etoposide in Treating Patients With HIV-Related Cancer

Primary Purpose

Lymphoma, Sarcoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
altretamine
etoposide
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma, AIDS-related peripheral/systemic lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 1, 2013
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002936
Brief Title
Altretamine and Etoposide in Treating Patients With HIV-Related Cancer
Official Title
Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Sarcoma
Keywords
AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma, AIDS-related peripheral/systemic lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
altretamine
Intervention Type
Drug
Intervention Name(s)
etoposide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence P. Leichman, MD
Organizational Affiliation
Albany Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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Altretamine and Etoposide in Treating Patients With HIV-Related Cancer

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