Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 1, 1999
February 1, 2013
July 1996
January 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002936 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Altretamine and Etoposide in Treating Patients With HIV-Related Cancer
Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Lymphoma
  • Sarcoma
  • Drug: altretamine
  • Drug: etoposide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
January 2007   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002936
DS 95-05, RPCI-DS-95-05, NCI-G97-1165
Not Provided
Not Provided
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Lawrence P. Leichman, MD Albany Medical College
Roswell Park Cancer Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP