Altretamine and Etoposide in Treating Patients With HIV-Related Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma; Sarcoma
Intervention: altretamine (Drug); etoposide (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Roswell Park Cancer Institute Official(s) and/or principal investigator(s):
Lawrence P. Leichman, MD, Study Chair, Affiliation: Cancer Center of Albany Medical Center
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.
Clinical Details
Official title: Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial
Study design: Treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 1996
Last updated: May 23, 2008
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