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| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00813423 |
Purpose
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib together with hydroxychloroquine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib when given together with hydroxychloroquine in treating patients with advanced solid tumors that have not responded to chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: hydroxychloroquine Drug: sunitinib malate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Autophagic Modulation With Anti-Angiogenic Therapy in Patients With Advanced Malignancies: A Phase I Trial of Sunitinib and Hydroxychloroquine |
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2008 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of sunitinib malate.
Patients receive oral sunitinib malate once daily and oral hydroxychloroquine twice daily on days 1-28. Treatment repeats every 42 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have undergone treatment with ≥ 1 regimen of standard therapy (i.e., cytotoxic chemotherapy, an oral targeted agent, or immunotherapy)
No diagnosis or history of CNS disease (i.e., primary brain tumor, malignant seizures, untreated CNS metastases, or carcinomatous meningitis)
PATIENT CHARACTERISTICS:
No ongoing grade 2 (NCI CTCAE v3.0) ventricular cardiac dysrhythmias
None of the following conditions within the past 6 months:
PRIOR CONCURRENT THERAPY:
More than 2 weeks since prior and no concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), St. John's wort, ketoconazole, dexamethasone, the dysrhythmic drugs (e.g., terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice
Contacts and Locations
More Information
| Responsible Party: | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Janice M. Mehnert ) |
| Study ID Numbers: | CDR0000630334, P30CA072720, CINJ-050801, 0220080281 |
| Study First Received: | December 20, 2008 |
| Last Updated: | December 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00813423 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific recurrent breast cancer recurrent adrenocortical carcinoma recurrent neuroendocrine carcinoma of the skin recurrent pheochromocytoma recurrent parathyroid cancer recurrent pituitary tumor recurrent thyroid cancer recurrent intraocular melanoma recurrent retinoblastoma recurrent cervical cancer recurrent gestational trophoblastic tumor recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor recurrent endometrial carcinoma |
recurrent vaginal cancer recurrent vulvar cancer recurrent anal cancer recurrent colon cancer recurrent rectal cancer recurrent esophageal cancer recurrent extrahepatic bile duct cancer recurrent gallbladder cancer recurrent gastric cancer recurrent gastrointestinal carcinoid tumor recurrent adult primary liver cancer recurrent pancreatic cancer recurrent small intestine cancer recurrent extragonadal germ cell tumor recurrent extragonadal seminoma |
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Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors Pharmacologic Actions |
Antimalarials Antiparasitic Agents Sunitinib Hydroxychloroquine Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Antirheumatic Agents |