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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rebimastat
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Washington University School of Medicine
  • Herbert Irving Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00024024
Brief Title
BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma
Official Title
A Phase I-II Trial Of BMS-275291 In Patients With HIV-Related Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
rebimastat

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Hayden Von Roenn, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18224669
Citation
Brinker BT, Krown SE, Lee JY, Cesarman E, Chadburn A, Kaplan LD, Henry DH, Von Roenn JH. Phase 1/2 trial of BMS-275291 in patients with human immunodeficiency virus-related Kaposi sarcoma: a multicenter trial of the AIDS Malignancy Consortium. Cancer. 2008 Mar 1;112(5):1083-8. doi: 10.1002/cncr.23108.
Results Reference
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BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma

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