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

NCT00024024 | Completed Phase 1

• 4 other identifiers: NCI-2012-02410AMC-024CPMC-IRB-13985CDR0000068885
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

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.

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcoma; recurrent Kaposi sarcoma

Study Arms (1)

Arm I

EXPERIMENTAL

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

Interventions

rebimastat DRUG

Arm I

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 18224669 RESULT

MeSH Terms

Conditions

Sarcoma; AIDS-related Kaposi sarcoma; Sarcoma, Kaposi

Interventions

N-((2S)-2-mercapto-1-oxo-4-(3,4,4- trimethyl-2,5-dioxo-1-imidazolidinyl)butyl)-L-leucyl-N,3- dimethyl-L-Valinamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neoplasms, Vascular Tissue

Study Officials

• Jamie Hayden Von Roenn, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: August 5, 2003
• Study Start: August 1, 2001
• Primary Completion: August 1, 2003
• Last Updated: February 11, 2013

Record last verified: 2008-04

Locations

US (3)