Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma (NCT00090987) | Clinical Trial Compass
CompletedPhase 2
Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
United States30 participantsStarted 2005-06
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 withi…
What they're measuring
1
Proportion of Patients Who Achieve a Clinical Response