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Phase 2 N=30 Treatment

Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma

Sarcoma

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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