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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA070019 | U.S. NIH Grant/Contract | View source | |
| CDR0000380955 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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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
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib mesylate | Experimental | Imatinib mesylate (Gleevec) taken 400 mg orally once a day for up to 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imatinib mesylate | Drug | 400 mg orally once a day for up to 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 20-24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry | 12 months | |
| Cytokine Profiles Before and After Imatinib Therapy | 12 months | |
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DISEASE CHARACTERISTICS:
Histologically confirmed Kaposi's sarcoma (KS) involving at least 1 of the following areas:
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
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
AST and ALT ≤ 2.5 times upper limit of normal
Bilirubin normal
No acute or known chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Ariela Noy, MD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Henry Koon, MD | Beth Israel Deaconess Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores UCSD Cancer Center | La Jolla | California | 92093-0658 | United States | ||
| USC/Norris Comprehensive Cancer Center and Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16687713 | Background | 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. | |
| 16862153 | Background | 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. |
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Three patients withdrew from the study before receiving treatment.
Date of Recruitment: August 4, 2005 to August 29, 2007 at 12 AMC clinical centers
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| ID | Title | Description |
|---|---|---|
| FG000 | Imatinib Mesylate (Gleevec) | Imatinib mesylate (Gleevec) is administered 400 mg orally once a day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2007 |
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| Pharmacokinetic Profile of Imatinib and Antiretrovirals |
| 12 months |
| 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 | 12 months |
| Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus | 12 months |
| Los Angeles |
| California |
| 90089-9181 |
| United States |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs | California | 92262 | United States |
| UCSF Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Memorial Sloan - Kettering Cancer Center | New York | New York | 10021 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | United States |
| Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| 24378417 | Background | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Imatinib Mesylate (Gleevec) | Imatinib mesylate (Gleevec) is administered 400 mg orally once a day |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | proportion | 20-24 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Cytokine Profiles Before and After Imatinib Therapy | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of Imatinib and Antiretrovirals | Not Posted | 12 months | Participants | ||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | 12 months | Participants | |||||||||||||||||||||||||||||||
| Secondary | Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus | Not Posted | 12 months | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imatinib Mesylate (Gleevec) | Imatinib mesylate (Gleevec) is administered 400 mg orally once a day | 2 | 30 | 20 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Blood and lymphatic system disorders | Hemorrhage, GI/esophagus |
| ||
| Infection | Infections and infestations | Infection with normal ANC or Grade 1-2 Neutrophils of the skin (cellulitis) |
| ||
| Secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT | Metabolism and nutrition disorders |
| |||
| Alkaline Phosphatase | Metabolism and nutrition disorders |
| |||
| Amylase | Metabolism and nutrition disorders |
| |||
| Anorexia | Gastrointestinal disorders |
| |||
| Blood/Bone Marrow | Blood and lymphatic system disorders |
| |||
| Bruising | Skin and subcutaneous tissue disorders |
| |||
| CPK | Metabolism and nutrition disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dermatology/skin, other | Skin and subcutaneous tissue disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Edema, limb | Blood and lymphatic system disorders |
| |||
| Fatigue | General disorders |
| |||
| Gastrointestinal, other | Gastrointestinal disorders |
| |||
| Hemoglobin | Blood and lymphatic system disorders |
| |||
| Hyperbilirubinemia | Metabolism and nutrition disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Hypocalcemia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Hypophosphatemia | Metabolism and nutrition disorders |
| |||
| Insomnia | General disorders |
| |||
| Leukocytes (total WBC) | Blood and lymphatic system disorders |
| |||
| Metabolic/laboratory other | Metabolism and nutrition disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Neutrophil Count | Blood and lymphatic system disorders |
| |||
| Pain, abdominal | Gastrointestinal disorders |
| |||
| Pain, back | Musculoskeletal and connective tissue disorders |
| |||
| Pain, chest | Respiratory, thoracic and mediastinal disorders |
| |||
| Pain, extremity | Musculoskeletal and connective tissue disorders |
| |||
| Pain, muscle | Musculoskeletal and connective tissue disorders |
| |||
| Platelets | Blood and lymphatic system disorders |
| |||
| Taste Alteration | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Abdominal bloating | Gastrointestinal disorders | MedDRA (10.0) |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeannette Y. Lee, Director of Statistical Center | AMC | (501) 526-6712 | jylee@uams.edu |
| May 3, 2018 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| C554498 | AIDS-related Kaposi sarcoma |
| D012514 | Sarcoma, Kaposi |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009383 | Neoplasms, Vascular Tissue |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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