Clinical trial · Interventional
Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma
NCT00090987CI-TRIAL-00033231completedPhase 2Results postedClinicalTrials.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)
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.
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 |
|---|---|---|---|
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib mesylate
- description
- Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months
- interventionNames
- Drug: imatinib mesylate
Primary outcomes (1)
- measure
- Proportion of Patients Who Achieve a Clinical Response
- timeFrame
- 20-24 weeks
- description
- Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for \>4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed Kaposi's sarcoma (KS) involving at least 1 of the following areas: * Skin * Lymph nodes * Oral cavity * Gastrointestinal tract\* * Lungs\* NOTE: \*Must be asymptomatic or minimally symptomatic AND does not require systemic cytotoxic therapy * Serological documentation of HIV infection, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), Western Blot test, or other federally approved licensed HIV test * At least 5 measurable, non-irradiated, cutaneous indicator lesions * Patients must have 3 lesions at least 5 x 5 mm that are accessible for 4 mm punch biopsy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * At least 3 months Hematopoietic * Hemoglobin ≥ 8.0 g/dL * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin normal * Patients with elevated bilirubin secondary to indinavir or atazanavir allowed provided total bilirubin is \< 3.5 mg/dL AND direct bilirubin is normal * No acute or known chronic liver disease (e.g., chronic active hepatitis or cirrhosis) * Hepatitis C infection with minimal or no fibrosis on liver biopsy allowed Renal * Creatinine ≤ 1.5 mg/dL OR * Creatinine clearance \> 60 mL/min Cardiovascular * No New York Heart Association class III or IV cardiac disease * No congestive heart failure * No myocardial infarction within the past 6 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after study participation * No concurrent active opportunistic infection * No other severe and/or life-threatening medical disease * No other malignancy within the past 5 years except clinically insignificant malignancy not requiring active intervention, basal cell skin cancer, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior biologic therapy for KS * More than 2 weeks since prior granulocyte colony-stimulating factor * No concurrent biologic agents for KS Chemotherapy * More than 4 weeks since prior chemotherapy for KS (6 weeks for nitrosoureas or mitomycin) * No concurrent chemotherapy for KS, including systemic cytotoxic chemotherapy Endocrine therapy * No concurrent systemic corticosteroid therapy except replacement doses Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy for KS * No concurrent radiotherapy for KS Surgery * More than 2 weeks since prior major surgery Other * No prior imatinib mesylate * More than 60 days since prior local therapy to any KS indicator lesion unless the lesion has progressed since treatment * More than 4 weeks since prior investigational therapy for KS * More than 4 weeks since other prior therapy for KS * More than 14 days since prior acute treatment for an infection or other serious medical illness * No concurrent warfarin * No concurrent grapefruit juice * No other concurrent therapy for KS * No other concurrent investigational drugs * Concurrent antiretroviral therapy required except for patients who have exhausted all available treatment options
References
Publications (3)
- BACKGROUNDBerman E, Nicolaides M, Maki RG, Fleisher M, Chanel S, Scheu K, Wilson BA, Heller G, Sauter NP. Altered bone and mineral metabolism in patients receiving imatinib mesylate. N Engl J Med. 2006 May 11;354(19):2006-13. doi: 10.1056/NEJMoa051140. PMID 16687713
- BACKGROUNDKerkela R, Grazette L, Yacobi R, Iliescu C, Patten R, Beahm C, Walters B, Shevtsov S, Pesant S, Clubb FJ, Rosenzweig A, Salomon RN, Van Etten RA, Alroy J, Durand JB, Force T. Cardiotoxicity of the cancer therapeutic agent imatinib mesylate. Nat Med. 2006 Aug;12(8):908-16. doi: 10.1038/nm1446. Epub 2006 Jul 23. PMID 16862153
- BACKGROUNDKoon HB, Krown SE, Lee JY, Honda K, Rapisuwon S, Wang Z, Aboulafia D, Reid EG, Rudek MA, Dezube BJ, Noy A. Phase II trial of imatinib in AIDS-associated Kaposi's sarcoma: AIDS Malignancy Consortium Protocol 042. J Clin Oncol. 2014 Feb 10;32(5):402-8. doi: 10.1200/JCO.2012.48.6365. Epub 2013 Dec 30. PMID 24378417