Phase 2
N=30
Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00090987 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Jul 2011
Primary outcome: Primary: Proportion of Patients Who Achieve a Clinical Response — 0.33 proportion
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- imatinib mesylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AIDS Malignancy Consortium
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Who Achieve a Clinical Response |
0.33 | — |
| SECONDARY Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry |
— | — |
| SECONDARY Cytokine Profiles Before and After Imatinib Therapy |
— | — |
| SECONDARY Pharmacokinetic Profile of Imatinib and Antiretrovirals |
— | — |
| SECONDARY Mechanisms of Primary and Secondary Resistance to Imatinib Therapy |
— | — |
| SECONDARY Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus |
— | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00090987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.