- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00890747
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
Study Overview
Status
Conditions
- HIV Infection
- Clear Cell Renal Cell Carcinoma
- Primary Myelofibrosis
- Polycythemia Vera
- Essential Thrombocythemia
- Chronic Myelomonocytic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Nodal Marginal Zone B-cell Lymphoma
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Waldenström Macroglobulinemia
- Unspecified Adult Solid Tumor, Protocol Specific
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With Del(5q)
- Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Peripheral T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Chronic Phase Chronic Myelogenous Leukemia
- Cutaneous B-cell Non-Hodgkin Lymphoma
- Hepatosplenic T-cell Lymphoma
- Intraocular Lymphoma
- Post-transplant Lymphoproliferative Disorder
- Previously Treated Myelodysplastic Syndromes
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Hodgkin Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Refractory Multiple Myeloma
- Relapsing Chronic Myelogenous Leukemia
- Testicular Lymphoma
- Prolymphocytic Leukemia
- Refractory Chronic Lymphocytic Leukemia
- Chronic Neutrophilic Leukemia
- Stage IV Renal Cell Cancer
- Recurrent Renal Cell Cancer
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Plasma Cell Neoplasm
- Refractory Hairy Cell Leukemia
- T-cell Large Granular Lymphocyte Leukemia
- Acute Undifferentiated Leukemia
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
- Mast Cell Leukemia
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Primary Systemic Amyloidosis
- Adult Grade III Lymphomatoid Granulomatosis
- Light Chain Deposition Disease
- Progressive Hairy Cell Leukemia, Initial Treatment
- de Novo Myelodysplastic Syndromes
- Noncutaneous Extranodal Lymphoma
- Chronic Eosinophilic Leukemia
- Aggressive NK-cell Leukemia
- AIDS-related Diffuse Large Cell Lymphoma
- AIDS-related Diffuse Mixed Cell Lymphoma
- AIDS-related Diffuse Small Cleaved Cell Lymphoma
- AIDS-related Immunoblastic Large Cell Lymphoma
- AIDS-related Lymphoblastic Lymphoma
- AIDS-related Small Noncleaved Cell Lymphoma
- Extramedullary Plasmacytoma
- HIV-associated Hodgkin Lymphoma
- Isolated Plasmacytoma of Bone
- Myeloid/NK-cell Acute Leukemia
- Myelodysplastic Syndrome With Isolated Del(5q)
- Adult Langerhans Cell Histiocytosis
- AIDS-related Malignancies
- Osteolytic Lesions of Multiple Myeloma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the safety and to investigate the pharmacological interactions of administering sunitinib (sunitinib malate) in subjects with cancer who are also HIV positive on anti-retroviral regimens containing protease inhibitors and/or non-nucleoside reverse transcriptase inhibitors.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of sunitinib in treating non-acquired immunodeficiency syndrome (AIDS) defining cancers (NADCs) in these subjects.
II. To detect alterations in antiretroviral drug pharmacokinetics due to sunitinib.
III. To detect alterations in immune parameters, including total leukocyte count, cluster of differentiation (CD) 4 and viral load, during sunitinib therapy.
IV. To correlate variations in genes involved in sunitinib absorption, metabolism, and elimination, including cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4), cytochrome P450, family 3, subfamily A, polypeptide 5 (CYP3A5), ATP-binding cassette, sub-family B (MDR/TAP), member 1 (ABCB1), and breast cancer resistance protein (ABCG2), with drug pharmacokinetics.
V. To explore the potential for pharmacological interactions between sunitinib and newer antiretroviral agents such as integrase and chemokine (C-C motif) receptor 5 (gene/pseudogene) (CCR5) inhibitors.
OUTLINE: This is a dose-escalation study.
Patients receive sunitinib malate orally (PO) daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Jonsson Comprehensive Cancer Center
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20057
- Lombardi Comprehensive Cancer Center at Georgetown University
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- AIDS - Associated Malignancies Clinical Trials Consortium
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
-
Missouri
-
Saint Loius, Missouri, United States, 63110
- Washington University - Jewish
-
-
New York
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Bronx, New York, United States, 10461
- Albert Einstein College Of Medicine
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
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Ohio
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Creatinine within institutional normal limits or glomerular filtration rate (GFR) > 60 mL/min/m^2 (calculated by the Cockcroft-Gault equation), calculated as follows:
- For males = (140 - age[years]) x (body weight [kg])/ (72) x (serum creatinine [mg/dL])
- For females = 0.85 x male value
- Total bilirubin should be =< 1.5 times upper limit of normal (ULN); if, however, the elevated bilirubin is felt to be secondary to indinavir therapy, then subjects will be allowed on protocol if total bilirubin =< 3.5 mg/dL, provided that the direct bilirubin is =< 1.5 times ULN; if the elevated bilirubin is felt to be secondary to atazanavir therapy, then subjects will be allowed on protocol without any limit on the total bilirubin if the direct bilirubin is =< 1.5 times ULN
- Aspartate transaminase AST (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase ALT (serum glutamate pyruvate transaminase [SGPT]) < 2.5 times the ULN; unless subjects have liver metastases, in which case both AST and ALT must be =< 5 times ULN
- Life expectancy of 3 months or more
- Ability and willingness to give informed consent
- Subjects must in the opinion of the Investigator be capable of complying with this protocol
Exclusion Criteria:
- 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
- Female subjects who are pregnant or breast-feeding
- Another severe and/or life-threatening medical disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (sunitinib malate)
Patients receive sunitinib malate PO daily on days 1-28.
Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Correlative studies
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grades 3, 4, and 5, treatment-related adverse events, graded according to the National Cancer Institute (NCI) CTCAE version 3.0
Time Frame: Up to 30 days after completion of study treatment
|
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
Time Frame: 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of response
Time Frame: Up to 30 days after completion of study treatment
|
Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) (solid tumors), AIDS Clinical Trials Group (ACTG) (Kaposi's sarcoma [KS]), Cheson (lymphoma), Durie (multiple myeloma), or International Working Group for Response Criteria for acute leukemias criteria depending on the subject's primary disease.
|
Up to 30 days after completion of study treatment
|
Antiretroviral drug pharmacokinetics due to sunitinib malate
Time Frame: At baseline and at 1, 2, 3, 4, 5, 6, 7, 8, and 24 hours of days 1and 2
|
Pharmacokinetic parameters within the individual groups will be compared using a Kruskall-Wallis test, Wilcoxon non-parametric test for paired data and Mann-Whitney test for unpaired data.
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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
Time Frame: Up to 30 days after completion of study treatment
|
Up to 30 days after completion of study treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John Deeken, AIDS Associated Malignancies Clinical Trials Consortium
Publications and helpful links
General Publications
- 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.
- Rais 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Kidney Neoplasms
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- DNA Virus Infections
- Bacterial Infections and Mycoses
- Proteostasis Deficiencies
- Tumor Virus Infections
- Blood Coagulation Disorders
- Blood Platelet Disorders
- Precancerous Conditions
- Leukocyte Disorders
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Leukemia, B-Cell
- Neoplasms, Connective Tissue
- Lung Diseases, Interstitial
- Eosinophilia
- Eye Neoplasms
- Lymphadenopathy
- Bone Marrow Neoplasms
- Hematologic Neoplasms
- Mastocytosis, Systemic
- Mastocytosis
- Neoplasms
- HIV Infections
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Carcinoma, Renal Cell
- Syndrome
- Myelodysplastic Syndromes
- Primary Myelofibrosis
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Hodgkin Disease
- Recurrence
- Lymphoma, Non-Hodgkin
- Immunoglobulin Light-chain Amyloidosis
- Amyloidosis
- Preleukemia
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myelomonocytic, Juvenile
- Mycoses
- Thrombocytosis
- Thrombocythemia, Essential
- Burkitt Lymphoma
- Lymphoma, Mantle-Cell
- Lymphoma, B-Cell, Marginal Zone
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma, Large-Cell, Immunoblastic
- Plasmablastic Lymphoma
- Waldenstrom Macroglobulinemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Hypereosinophilic Syndrome
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
- Lymphoma, T-Cell, Cutaneous
- Leukemia, T-Cell
- Leukemia-Lymphoma, Adult T-Cell
- Plasmacytoma
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, Large-Cell, Anaplastic
- Lymphomatoid Granulomatosis
- Leukemia, Myeloid, Accelerated Phase
- Lymphoma, Extranodal NK-T-Cell
- Intraocular Lymphoma
- Lymphoproliferative Disorders
- Immunoblastic Lymphadenopathy
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Leukemia, Prolymphocytic
- Histiocytosis, Langerhans-Cell
- Histiocytosis
- Polycythemia Vera
- Polycythemia
- Leukemia, Hairy Cell
- Leukemia, Large Granular Lymphocytic
- Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
- Leukemia, Mast-Cell
- Leukemia, Neutrophilic, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- NCI-2012-02208 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U01CA121947 (U.S. NIH Grant/Contract)
- AMC-061 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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