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Sponsors and Collaborators: |
AIDS Associated Malignancies Clinical Trials Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00890747 |
RATIONALE: Sunitinib malate may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects of sunitinib malate in treating HIV-positive patients with cancer undergoing highly active antiretroviral therapy.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: sunitinib malate Other: liquid chromatography Other: mass spectrometry Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase 1/Pharmacokinetic Study of Sunitinib in Patients With Cancer Who Also Have HIV and Are on HAART Therapy |
Estimated Enrollment: | 42 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to type of highly active antiretroviral therapy (non-nucleoside reverse transcriptase inhibitor-based therapy vs non-ritonavir protease inhibitor [PI]-based therapy vs ritonavir PI-based therapy).
Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for pharmacokinetic studies by liquid chromatography-tandem mass spectrometry (LC-MS/MS).
After completion of study therapy, patients are followed for at least 1 month.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy proven malignancy, including any of the following:
Hematologic malignancy for which effective standard therapy or other curative options are not available
Has been on stable antiretroviral therapy for ≥ 4 weeks that includes a protease inhibitor-based or non-nucleoside reverse transcriptase inhibitor-based regimen of ≥ 3 drugs
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000639703, AMC-061 |
Study First Received: | April 29, 2009 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00890747 History of Changes |
Health Authority: | Unspecified |
HIV infection stage IV renal cell cancer recurrent renal cell cancer unspecified adult solid tumor, protocol specific accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) atypical chronic myeloid leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia mast cell leukemia |
meningeal chronic myelogenous leukemia progressive hairy cell leukemia, initial treatment prolymphocytic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult T-cell leukemia/lymphoma refractory chronic lymphocytic leukemia refractory hairy cell leukemia relapsing chronic myelogenous leukemia secondary acute myeloid leukemia stage III adult T-cell leukemia/lymphoma stage III chronic lymphocytic leukemia stage IV adult T-cell leukemia/lymphoma stage IV chronic lymphocytic leukemia T-cell large granular lymphocyte leukemia |
Urogenital Neoplasms Mantle Cell Lymphoma Preleukemia Leukemia, Prolymphocytic Hemorrhagic Disorders Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic Kidney Diseases Myelodysplastic Myeloproliferative Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders |
Leukemia, Myeloid Carcinoma Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase HIV Infections Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Neoplasms, Glandular and Epithelial Precancerous Conditions Blood Protein Disorders Lymphoma, Follicular Sezary Syndrome Lymphoblastic Lymphoma Lymphoma, B-Cell |
Precancerous Conditions Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Paraproteinemias Urogenital Neoplasms Hemostatic Disorders Urologic Neoplasms Leukemia Preleukemia Hemorrhagic Disorders Pathologic Processes Neoplasms by Site Urologic Diseases Sunitinib |
Kidney Neoplasms Therapeutic Uses Syndrome Lymphoma, Large-Cell, Immunoblastic Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Kidney Diseases Lymphoma Immunoproliferative Disorders Disease Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Growth Substances |