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A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Trial Of Imatinib Mesylate (Gleevec) In Patients With HIV Related Kaposi's Sarcoma



- Determine clinical response in patients with HIV-related Kaposi's sarcoma treated with
imatinib mesylate.


- 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

- Determine the pharmacokinetic profile of this drug and antiretrovirals in these

- Determine mechanisms of primary and secondary resistance to this drug in these

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.

Inclusion Criteria


- Histologically confirmed Kaposi's sarcoma (KS) involving at least 1 of the following

- 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



- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- At least 3 months


- Hemoglobin ≥ 8.0 g/dL

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 75,000/mm^3


- 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


- Creatinine ≤ 1.5 mg/dL OR

- Creatinine clearance > 60 mL/min


- No New York Heart Association class III or IV cardiac disease

- No congestive heart failure

- No myocardial infarction within the past 6 months


- 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


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


- More than 4 weeks since prior chemotherapy for KS (6 weeks for nitrosoureas or

- No concurrent chemotherapy for KS, including systemic cytotoxic chemotherapy

Endocrine therapy

- No concurrent systemic corticosteroid therapy except replacement doses


- See Disease Characteristics

- More than 4 weeks since prior radiotherapy for KS

- No concurrent radiotherapy for KS


- More than 2 weeks since prior major surgery


- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Patients Who Achieve a Clinical Response

Outcome Description:

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

Outcome Time Frame:

20-24 weeks

Safety Issue:


Principal Investigator

Ariela Noy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2005

Completion Date:

December 2009

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • Sarcoma



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
UCSF Comprehensive Cancer Center San Francisco, California  94115
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia, Pennsylvania  19107
Moores UCSD Cancer Center La Jolla, California  92093-0658
University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136
Desert Regional Medical Center Comprehensive Cancer Center Palm Springs, California  92262
Memorial Sloan - Kettering Cancer Center New York, New York  10021
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center Seattle, Washington  98111