A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma
imatinib mesylate
DNA Virus Infections+7
+ Herpesviridae Infections
+ Infections
Treatment Study
Summary
Study start date: June 1, 2005
Actual date on which the first participant was enrolled.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 factor receptors, as determined by immunohistochemistry, in patients treated with this drug. * Determine cytokine profiles before and after treatment with this drug in these patients. * Determine the pharmacokinetic profile of this drug and antiretrovirals in these patients. * Determine mechanisms of primary and secondary resistance to this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral imatinib mesylate once daily. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesJonsson Comprehensive Cancer Center at UCLA
Los Angeles, United StatesDesert Regional Medical Center Comprehensive Cancer Center
Palm Springs, United States