BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma

February 8, 2013 updated by: National Cancer Institute (NCI)

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

Phase I/II trial to study the effectiveness of BMS-275291 in treating patients who have HIV-related Kaposi's sarcoma. Drugs such as BMS-275291 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

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 sarcoma.

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 750/mm3
  • Platelet count at least 75,000/mm3
  • Hemoglobin at least 8 g/dL

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance greater than 60 mL/min

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Other:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
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.
Drug: rebimastat

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

August 4, 2003

First Posted (Estimate)

August 5, 2003

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02410
  • AMC-024
  • CPMC-IRB-13985
  • CDR0000068885 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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