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


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

A Phase II Trial Of Imatinib Mesylate (Gleevec) In 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.

Inclusion 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 < 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

Type of Study:

Interventional

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:

No

Principal Investigator

Ariela Noy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000380955

NCT ID:

NCT00090987

Start Date:

June 2005

Completion Date:

December 2009

Related Keywords:

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

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Joan Karnell Cancer Center at Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Desert Regional Medical Center Comprehensive Cancer CenterPalm Springs, California  92262
Memorial Sloan - Kettering Cancer CenterNew York, New York  10021
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical CenterSeattle, Washington  98111