Status:
COMPLETED
Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
The Emmes Company, LLC
Conditions:
Sarcoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 treati...
Detailed Description
OBJECTIVES: Primary * Determine clinical response in patients with HIV-related Kaposi's sarcoma treated with imatinib mesylate. Secondary * Determine the inhibition of platelet-derived growth fact...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00090987
Start Date
June 1 2005
End Date
December 1 2009
Last Update
June 6 2018
Active Locations (15)
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1
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
2
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
3
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
4
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs, California, United States, 92262