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

This study has been completed.
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00090987
First received: September 7, 2004
Last updated: August 27, 2014
Last verified: August 2014

September 7, 2004
August 27, 2014
June 2005
December 2009   (final data collection date for primary outcome measure)
Proportion of Patients Who Achieve a Clinical Response [ Time Frame: 20-24 weeks ] [ Designated as safety issue: No ]
Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for >4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions
Not Provided
Complete list of historical versions of study NCT00090987 on ClinicalTrials.gov Archive Site
  • Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cytokine Profiles Before and After Imatinib Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic Profile of Imatinib and Antiretrovirals [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mechanisms of Primary and Secondary Resistance to Imatinib Therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression
  • Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma
A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma
Drug: imatinib mesylate
400 mg orally once a day for up to 6 months.
Other Name: Gleevec
Experimental: Imatinib mesylate
Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months
Intervention: Drug: imatinib mesylate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00090987
AMC-042, U01CA070019, CDR0000380955
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
  • National Cancer Institute (NCI)
  • The EMMES Corporation
Study Chair: Ariela Noy, MD Memorial Sloan-Kettering Cancer Center
Study Chair: Henry Koon, MD Beth Israel Deaconess Medical Center
AIDS Malignancy Clinical Trials Consortium
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP