CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
imatinib mesylatedrug
Likely dose
Imatinib mesylate 400 mg orally once dailyAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed Kaposi's sarcoma involving skin, lymph nodes, oral cavity, GI tract (asymptomatic/minimally symptomatic), or lungs (asymptomatic/minimally symptomatic, not requiring systemic cytotoxic therapy)
  • ✓Serological documentation of HIV infection by ELISA, Western Blot, or federally approved HIV test
  • ✓At least 5 measurable, non-irradiated, cutaneous indicator lesions with 3 lesions ≥5×5 mm accessible for 4 mm punch biopsy
  • ✓Age 18 years or older
Key exclusion· 8
  • ✕Prior imatinib mesylate treatment
  • ✕Concurrent active opportunistic infection
  • ✕New York Heart Association class III or IV cardiac disease, congestive heart failure, or myocardial infarction within past 6 months
  • ✕Acute or chronic liver disease (e.g., cirrhosis or chronic active hepatitis); hepatitis C allowed only with minimal/no fibrosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00090987
NCT00090987Phase 2Completed
CompareCT.gov

A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma

AIDS Malignancy Consortium·interventional·Posted Sep 8, 2004·Updated Jun 6, 2018

In Brief

A Phase 2 clinical trial evaluating imatinib mesylate for Sarcoma. Completed, enrolled 30 participants across 15 sites.

Detailed Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with HIV-related Kaposi's sarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), The Emmes Company, LLC

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2004
Enrollment StartJun 1, 2005
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 21.8 years ago

Interventions

imatinib mesylatedrug

400 mg orally once a day for up to 6 months.