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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024024
First received: September 13, 2001
Last updated: February 8, 2013
Last verified: April 2008
History of Changes
  Purpose
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.

Condition Intervention Phase
Sarcoma Drug: rebimastat Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Trial Of BMS-275291 In Patients With HIV-Related Kaposi's Sarcoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):
Enrollment: 59
Study Start Date: August 2001
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024024

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Jamie Hayden Von Roenn, MD Robert H. Lurie Cancer Center
  More Information

Publications:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00024024     History of Changes
Other Study ID Numbers: NCI-2012-02410
AMC-024
CPMC-IRB-13985
CDR0000068885 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: September 13, 2001
Last Updated: February 8, 2013

Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma
recurrent Kaposi sarcoma

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
 Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on September 19, 2017