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Phase 2 Completed N=30 Treatment

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

Source: ClinicalTrials.gov NCT00090987 ↗
Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Jul 2011
Primary outcomePrimary: Proportion of Patients Who Achieve a Clinical Response — 0.33 proportion

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.

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
— —

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. Informational only — not medical advice.

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