Clinical trial · Interventional
BMS-275291 in Treating Patients With HIV-Related Kaposi's Sarcoma
A Phase I-II Trial Of BMS-275291 In Patients With HIV-Related Kaposi's Sarcoma
NCT00024024CI-TRIAL-00009397completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rebimastat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- 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.
- interventionNames
- Drug: rebimastat
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBrinker 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