Altretamine and Etoposide in Treating Patients With HIV-Related Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00002936
First received: November 1, 1999
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Sarcoma
Drug: altretamine
Drug: etoposide
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: July 1996
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002936

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Lawrence P. Leichman, MD Albany Medical College
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002936     History of Changes
Other Study ID Numbers: DS 95-05, RPCI-DS-95-05, NCI-G97-1165
Study First Received: November 1, 1999
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Roswell Park Cancer Institute:
AIDS-related Kaposi sarcoma
recurrent Kaposi sarcoma
AIDS-related peripheral/systemic lymphoma

Additional relevant MeSH terms:
Lymphoma
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Etoposide
Etoposide phosphate
Altretamine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014