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Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.

Sponsor:

Collaborators:

National Cancer Institute (NCI)

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

History of Changes

Results First Received: May 25, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Sarcoma
Intervention:	Drug: imatinib mesylate

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Date of Recruitment: August 4, 2005 to August 29, 2007 at 12 AMC clinical centers

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three patients withdrew from the study before receiving treatment.

Reporting Groups

	Description
Imatinib Mesylate (Gleevec)	Imatinib mesylate (Gleevec) is administered 400 mg orally once a day

Participant Flow: Overall Study

	Imatinib Mesylate (Gleevec)
STARTED	30
COMPLETED	9
NOT COMPLETED	21
Adverse Event	5
Lack of Efficacy	7
Withdrawal by Subject	3
alternative therapy	1
Non-compliance	4
Incarcerated	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Imatinib Mesylate (Gleevec)	Imatinib mesylate (Gleevec) is administered 400 mg orally once a day

Baseline Measures

	Imatinib Mesylate (Gleevec)
Number of Participants [units: participants]	30
Age [units: participants]
<=18 years	0
Between 18 and 65 years	29
>=65 years	1
Age [units: years] Mean ± Standard Deviation	43.2 ± 9.5
Gender [units: participants]
Female	1
Male	29
Region of Enrollment [units: participants]
United States	30

Outcome Measures

1. Primary:

Proportion of Patients Who Achieve a Clinical Response [ Time Frame: 20-24 weeks ]

Show Outcome Measure 1

2. Secondary:

Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry [ Time Frame: 12 months ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

3. Secondary:

Cytokine Profiles Before and After Imatinib Therapy [ Time Frame: 12 months ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

4. Secondary:

Pharmacokinetic Profile of Imatinib and Antiretrovirals [ Time Frame: 12 months ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

5. Secondary:

Mechanisms of Primary and Secondary Resistance to Imatinib Therapy [ Time Frame: 12 months ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

6. Secondary:

Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus [ Time Frame: 12 months ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Jeannette Y. Lee, Director of Statistical Center
Organization: AMC
phone: (501) 526-6712
e-mail: jylee@uams.edu

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.

Kerkelä 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. Epub 2006 Jul 23.

Publications automatically indexed to this study:

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.

Responsible Party:	AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:	NCT00090987 History of Changes
Other Study ID Numbers:	AMC-042, U01CA070019, CDR0000380955
Study First Received:	September 7, 2004
Results First Received:	May 25, 2011
Last Updated:	August 27, 2014
Health Authority:	United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board