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Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial

Phase 1
18 Years
Not Enrolling
Lymphoma, Sarcoma

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Trial Information

Hexamethylamine and VP-16 an Oral Regimin for HIV Malignancies: A Phase I/II Trial

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.

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Lawrence P. Leichman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Albany Medical College


United States: Federal Government

Study ID:

DS 95-05



Start Date:

July 1996

Completion Date:

Related Keywords:

  • Lymphoma
  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • AIDS-related peripheral/systemic lymphoma
  • Lymphoma
  • Sarcoma



Roswell Park Cancer Institute Buffalo, New York  14263