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SarcomaPhase 2NCT00090987

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

A Phase 2 study testing imatinib mesylate in people with Sarcoma, run by AIDS Malignancy Consortium at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Sarcoma
What is being tested?
imatinib mesylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
15 sitesUnited States
Study dates
Jun 2005to Dec 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

  • Memorial Sloan - Kettering Cancer Center

    New York, New York, 10021

  • Desert Regional Medical Center Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Joan Karnell Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19106

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Sarcoma
Being tested
imatinib mesylate
Keywords
AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma
Medical subject headings
Sarcoma, AIDS-related Kaposi sarcoma, Sarcoma, Kaposi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

    Also called Gleevec

    400 mg orally once a day for up to 6 months.

Study groups in NCT00090987
Study groupRoleWhat they receive
Imatinib mesylateExperimentalImatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months
Receives: Drug: imatinib mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Who Achieve a Clinical Response

    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

    Measured: 20-24 weeks

Secondary outcomes (5)

  1. Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry

    Measured: 12 months

  2. Cytokine Profiles Before and After Imatinib Therapy

    Measured: 12 months

  3. Pharmacokinetic Profile of Imatinib and Antiretrovirals

    Measured: 12 months

  4. Mechanisms of Primary and Secondary Resistance to Imatinib Therapy

    Mutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression

    Measured: 12 months

  5. Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2004 (estimated)
  2. Study startJun 2005
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00090987
Sponsor's protocol ID
AMC-042
Other IDs
U01CA070019, CDR0000380955
Status last verified
May 2018
First submitted
7 Sep 2004
Last updated
6 Jun 2018
Data monitoring committee
No

Publications

  • Berman E, Nicolaides M, Maki RG, Fleisher M, Chanel S, Scheu K, Wilson BA, Heller G, Sauter NP. Altered bone and mineral metabolism in patients receiving imatinib mesylate. N Engl J Med. 2006 May 11;354(19):2006-13. doi: 10.1056/NEJMoa051140.

    PubMed 16687713

  • Kerkela R, Grazette L, Yacobi R, Iliescu C, Patten R, Beahm C, Walters B, Shevtsov S, Pesant S, Clubb FJ, Rosenzweig A, Salomon RN, Van Etten RA, Alroy J, Durand JB, Force T. Cardiotoxicity of the cancer therapeutic agent imatinib mesylate. Nat Med. 2006 Aug;12(8):908-16. doi: 10.1038/nm1446. Epub 2006 Jul 23.

    PubMed 16862153

  • Koon HB, Krown SE, Lee JY, Honda K, Rapisuwon S, Wang Z, Aboulafia D, Reid EG, Rudek MA, Dezube BJ, Noy A. Phase II trial of imatinib in AIDS-associated Kaposi's sarcoma: AIDS Malignancy Consortium Protocol 042. J Clin Oncol. 2014 Feb 10;32(5):402-8. doi: 10.1200/JCO.2012.48.6365. Epub 2013 Dec 30.

    PubMed 24378417

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate in people with Sarcoma, run by AIDS Malignancy Consortium at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Who Achieve a Clinical Response (time frame: 20-24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00090987, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.

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