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BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Sarcoma | Drug: rebimastat | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I-II Trial Of BMS-275291 In Patients With HIV-Related Kaposi's Sarcoma |
| 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00024024
| 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 | |
| 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 June 23, 2017