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| Sponsor: | AIDS Malignancy Clinical Trials Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | AIDS Malignancy Clinical Trials Consortium |
| ClinicalTrials.gov Identifier: | NCT00890747 |
Purpose
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 |
|---|---|---|
|
Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Kidney Cancer Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Nonneoplastic Condition Unspecified Adult Solid Tumor, Protocol Specific |
Drug: sunitinib malate Other: liquid chromatography-tandem mass spectrometry Other: mass spectrometry Other: pharmacogenetic study |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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: | August 2009 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 (NNRTI-based therapy)
Subjects will receive 50 mg/day of therapy for 4 weeks, followed by 2 weeks off of therapy (6-week cycle). At least six subjects will be treated at the starting dose for Group 1. Further, six (6) patients on efavirenz-containing regimens will be recruited to Group 1.
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Drug: sunitinib malate
Sunitinib starting dose will be assigned by treatment arm and will be taken orally once daily for 4 weeks, followed by a 2 weeks off therapy (6-week cycle), for up to 8 cycles.
Other Name: Sutent
Other: liquid chromatography-tandem mass spectrometry
Pharmacokinetic analysis of sunitinib and SU012662 concentration in plasma samples.
Other: mass spectrometry
Pharmacokinetic analysis of antiretroviral agent concentration in plasma samples.
Other: pharmacogenetic study
DNA analysis to identify single nucleotide polymorphisms in the genes involved in sunitinib and ARV pharmacokinetics.
|
|
Experimental: Group 2 (non-ritonavir PI based therapy)
Planned accrual for Group 2 was up to six subjects treated at the starting dose of 50 mg/day of therapy for 4 weeks, followed by 2 weeks off of therapy (6-week cycle). Accrual to Group 2 was closed upon approval of Version 7.0 of the protocol.
|
Drug: sunitinib malate
Sunitinib starting dose will be assigned by treatment arm and will be taken orally once daily for 4 weeks, followed by a 2 weeks off therapy (6-week cycle), for up to 8 cycles.
Other Name: Sutent
Other: liquid chromatography-tandem mass spectrometry
Pharmacokinetic analysis of sunitinib and SU012662 concentration in plasma samples.
Other: mass spectrometry
Pharmacokinetic analysis of antiretroviral agent concentration in plasma samples.
Other: pharmacogenetic study
DNA analysis to identify single nucleotide polymorphisms in the genes involved in sunitinib and ARV pharmacokinetics.
|
|
Experimental: Group 3 (ritonavir PI-based therapy)
Dose escalation, phase I-like design with cohorts of three subjects enrolled on three different dose levels (25 mg/day, 37.5 mg/day, and 50 mg/day). Intra-patient dose escalations will be allowed.
|
Drug: sunitinib malate
Sunitinib starting dose will be assigned by treatment arm and will be taken orally once daily for 4 weeks, followed by a 2 weeks off therapy (6-week cycle), for up to 8 cycles.
Other Name: Sutent
Other: liquid chromatography-tandem mass spectrometry
Pharmacokinetic analysis of sunitinib and SU012662 concentration in plasma samples.
Other: mass spectrometry
Pharmacokinetic analysis of antiretroviral agent concentration in plasma samples.
Other: pharmacogenetic study
DNA analysis to identify single nucleotide polymorphisms in the genes involved in sunitinib and ARV pharmacokinetics.
|
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.
Eligibility| 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 (PI)-based or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen of ≥ 3 drugs
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| UCLA Clinical AIDS Research and Education (CARE) Center | |
| Los Angeles, California, United States, 90095-1793 | |
| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Illinois | |
| Northwestern Cancer Center | |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Pennsylvania | |
| Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Principal Investigator: | John F. Deeken, MD | Lombardi Cancer Research Center |
More Information
| Responsible Party: | AIDS Malignancy Clinical Trials Consortium |
| ClinicalTrials.gov Identifier: | NCT00890747 History of Changes |
| Other Study ID Numbers: | CDR0000639703, U01CA121947, AMC-061 |
| Study First Received: | April 29, 2009 |
| Last Updated: | December 1, 2011 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
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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, BCR-ABL negative 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 |
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Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Nervous System Neoplasms Lymphoma, Large-Cell, Immunoblastic |
Central Nervous System Neoplasms Myelodysplastic-Myeloproliferative Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders |