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A Phase I-II Trial Of BMS-275291 In Patients With HIV-Related Kaposi's Sarcoma

Phase 1/Phase 2
16 Years
Not Enrolling

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Trial Information

A Phase I-II Trial Of BMS-275291 In Patients With HIV-Related Kaposi's Sarcoma


I. Determine whether the change in percent of apoptotic cells on tumor biopsies before and
after treatment with BMS-275291 is a valid endpoint in patients with HIV-related Kaposi's

II. Determine the safety and tolerability of this drug in these patients. III. Determine the
antitumor effects of this drug in these patients. IV. Determine the effect of this drug on
overall quality of life and tumor-specific symptoms in these patients.

V. Determine the effect of this drug on CD4 and CD8 cell counts and percentages and HIV
viral load in these patients.

VI. Determine the effect of this drug on human herpes virus-8 (HHV-8) viral load and
correlate HHV-8 viral burden, tumor stage, and prognosis in these patients.

VII. Determine the peak plasma concentration of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral BMS-275291 1-2 times daily. Treatment repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of BMS-275291 until the recommended phase II
dose (RPTD) is determined. The RPTD is the dose at which no more than 1 of 6 patients
experiences dose-limiting toxicity and more than 1 of 6 patients experiences clinical
response or at least 5 of 6 patients demonstrate biologic activity. An additional 29
patients are treated at the RPTD.

Quality of life is assessed on day 15 of the first course and then every 28 days thereafter.

Patients are followed for at least 1 month.

Inclusion Criteria


- Histologically confirmed Kaposi's sarcoma (KS) with serologically documented HIV

- No symptomatic visceral KS requiring cytotoxic therapy unless refractory to or
intolerant of all currently approved agents for visceral KS

- At least 5 measurable lesions

- No prior local therapy to any indicator lesion unless clear progression has
taken place since treatment



- 16 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 3 months


- Absolute neutrophil count at least 750/mm3

- Platelet count at least 75,000/mm3

- Hemoglobin at least 8 g/dL


- Bilirubin no greater than 1.0 times upper limit of normal (ULN) (no greater than 3.5
mg/dL if secondary to indinavir therapy provided direct bilirubin normal)

- AST and ALT no greater than 3 times ULN


- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance greater than 60 mL/min


- No acute, active opportunistic infection within the past 14 days except oral thrush
or genital herpes

- No other serious medical illness within the past 14 days

- No other malignancy requiring cytotoxic therapy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study


Biologic therapy:

- At least 3 weeks since prior biologic therapy for KS and recovered


- At least 3 weeks since prior chemotherapy for KS and recovered

- No concurrent systemic chemotherapy for KS

Endocrine therapy:

- No concurrent corticosteroids except replacement doses


- At least 3 weeks since prior radiotherapy for KS and recovered


- All antiretroviral therapy must be at a stable dose for at least the past 4 weeks and
during treatment

- At least 3 weeks since prior local therapy for KS and recovered

- At least 3 weeks since prior investigational therapy for KS and recovered

- At least 14 days since prior acute treatment of infections other than thrush and
genital herpes

- Recovered from toxic effects of any other prior KS treatment

- No other concurrent investigational drugs except investigational new drug
(IND)-available antiretroviral agents

- No other concurrent KS-specific treatment

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jamie Hayden Von Roenn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2001

Completion Date:

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • Sarcoma



Washington University School of Medicine Saint Louis, Missouri  63110
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Herbert Irving Comprehensive Cancer Center New York, New York  10032