Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral Therapy
A Phase 1/Pharmacokinetic Study of Sunitinib in Patients With Cancer Who Also Have HIV and Are on HAART Therapy
3 other identifiers
interventional
42
1 country
11
Brief Summary
This phase I trial studies the side effects and the best dose of sunitinib malate in treating human immunodeficiency virus (HIV)-positive patients with cancer receiving antiretroviral therapy. Sunitinib malate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2009
CompletedFirst Posted
Study publicly available on registry
April 30, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedMarch 17, 2014
September 1, 2013
1.7 years
April 29, 2009
March 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Grades 3, 4, and 5, treatment-related adverse events, graded according to the National Cancer Institute (NCI) CTCAE version 3.0
Results will be presented descriptively. Continuous data will be summarized for each cohort using descriptive statistics (N, mean, median, standard deviation, minimum, maximum, geometric mean, and % coefficient of variation \[CV\]).
Up to 30 days after completion of study treatment
Dose-limiting toxicity (DLT) defined as an adverse event that is possibly related to the study medication, graded according to the NCI CTCAE version 3.0
Results will be presented descriptively. Continuous data will be summarized for each cohort using descriptive statistics (N, mean, median, standard deviation, minimum, maximum, geometric mean, and % coefficient of variation \[CV\]).
6 weeks
Secondary Outcomes (3)
Evaluation of response
Up to 30 days after completion of study treatment
Antiretroviral drug pharmacokinetics due to sunitinib malate
At baseline and at 1, 2, 3, 4, 5, 6, 7, 8, and 24 hours of days 1and 2
Alterations in immune parameters, including total leukocyte count, CD4, and viral load
Up to 30 days after completion of study treatment
Study Arms (1)
Treatment (sunitinib malate)
EXPERIMENTALPatients receive sunitinib malate PO daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Correlative studies
Eligibility Criteria
You may qualify if:
- Biopsy-proven solid tumor or hematological malignancy, including:
- Metastatic renal cell carcinoma
- A solid tumor malignancy, including an NADC or an AIDS-defining malignancy, if the subject has progressed following standard therapy and/or other curative options are not available
- A hematologic malignancy, except for blast-phase leukemia, for which effective standard therapy or other curative options are not available
- Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme linked immunosorbent assay (ELISA), positive western blotting (Western Blot), or other federally approved licensed HIV test, or a detectable blood level of HIV ribonucleic acid (RNA), or a positive anti-HIV antibody test
- On stable anti-retroviral therapy for at least 4 weeks with a protease inhibitor (PI)-based or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen of at least three drugs, with no intention to change the regimen within 8 weeks after starting study drug
- Patients who are on NNRTI and ritonavir PI-based therapy are eligible and will be enrolled in the ritonavir PI-based group (Group 3)
- Patients who are on NNRTI and non-ritonavir PI-based therapy are eligible and will be enrolled in the non-ritonavir PI-based group (Group 2); NOTE: accrual to Group 2 will be closed upon approval of version 7.0 of the protocol
- Patients who are on a highly active antiretroviral therapy (HAART) combination that includes neither a PI nor a NNRTI agent are eligible and will be enrolled in the NNRTI-based group (Group 1)
- CD4 count \> 50 cells/uL
- Karnofsky performance status \> 60%
- Women of child-bearing potential must have a negative pregnancy test within 7 days before initiation of study drug dosing; post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; male and female subjects of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug; (Note: a woman of childbearing potential is one who is biologically capable of becoming pregnant; this includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives)
- Hemoglobin \>= 8.0 gm/dL
- Absolute neutrophil count (ANC) \>= 1500 cells/mm\^3
- Platelet count \>= 100,000 /mm\^3
- +8 more criteria
You may not qualify if:
- Concurrent active opportunistic infection (OI)
- Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
- Receipt of antineoplastic therapy, including investigational drug or standard treatment, within 2 weeks of study entry; must be able to demonstrate adequate recovery from prior therapy-related toxicities
- Major surgery or radiation within 3 weeks prior to study entry
- Concurrent treatment with medications, other than antiretroviral drugs used to treat HIV infection, that are known to inhibit or induce CYP3A4
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease
- Clinically significant cardiovascular disease, including uncontrolled hypertension (diastolic blood pressure \>= 100 mmHg despite optimal medical therapy) or unstable angina
- A myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 6 months of study entry
- Abnormal left ventricular ejection fraction per institutional standards
- Ongoing ventricular cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) grade \>= 2
- Subjects with a history of serious ventricular arrhythmia (ventricular tachycardia \[VT\] or ventricular fibrillation \[VF\] \>= 3 beats in a row)
- Serious cardiac arrhythmia requiring medication
- QTc interval \> 500 msec
- Psychiatric illness that would limit compliance with study requirements
- Pre-existing thyroid abnormality that cannot be maintained with medication to keep measures of thyroid stimulating hormone within the normal range
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
Lombardi Comprehensive Cancer Center at Georgetown University
Washington D.C., District of Columbia, 20057, United States
Northwestern University
Chicago, Illinois, 60611, United States
AIDS - Associated Malignancies Clinical Trials Consortium
Rockville, Maryland, 20850, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Washington University - Jewish
Saint Loius, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Related Publications (2)
Rudek MA, Moore PC, Mitsuyasu RT, Dezube BJ, Aboulafia D, Gerecitano J, Sullivan R, Cianfrocca ME, Henry DH, Ratner L, Haigentz M Jr, Dowlati A, Little RF, Ivy SP, Deeken JF. A phase 1/pharmacokinetic study of sunitinib in combination with highly active antiretroviral therapy in human immunodeficiency virus-positive patients with cancer: AIDS Malignancy Consortium trial AMC 061. Cancer. 2014 Apr 15;120(8):1194-202. doi: 10.1002/cncr.28554. Epub 2014 Jan 28.
PMID: 24474568RESULTRais R, Zhao M, He P, Xu L, Deeken JF, Rudek MA. Quantitation of unbound sunitinib and its metabolite N-desethyl sunitinib (SU12662) in human plasma by equilibrium dialysis and liquid chromatography-tandem mass spectrometry: application to a pharmacokinetic study. Biomed Chromatogr. 2012 Nov;26(11):1315-24. doi: 10.1002/bmc.2697. Epub 2012 Jan 18.
PMID: 22259028DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Deeken
AIDS Associated Malignancies Clinical Trials Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2009
First Posted
April 30, 2009
Study Start
August 1, 2009
Primary Completion
May 1, 2011
Last Updated
March 17, 2014
Record last verified: 2013-09