Expired Study
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Houston, Texas 77030


Purpose:

RATIONALE: Drugs, such as fenretinide and lonafarnib, may stop the growth of head and neck cancer by blocking blood flow to the tumor. Fenretinide may also help tumor cells become normal cells. Lonafarnib may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fenretinide together with lonafarnib may kill more tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best dose of fenretinide and lonafarnib in treating patients with advanced or recurrent head and neck cancer.


Study summary:

OBJECTIVES: Primary - Determine the biological activity and tolerability of fenretinide and lonafarnib in patients with advanced or recurrent squamous cell carcinoma of the head and neck. - Determine the toxicity profile of this regimen in these patients. - Determine the maximum tolerated dose of this regimen in these patients. Secondary - Determine the dose-limiting toxicity of this regimen in these patients. - Determine a recommended phase II dose of this regimen in these patients. OUTLINE: This is a dose-escalation study followed by a randomized study. - Dose-escalation portion: Patients receive oral fenretinide twice daily on days 1-7 and oral lonafarnib twice daily on days 1*-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of fenretinide and lonafarnib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. - Randomized portion: After the dose-escalation portion of this study is completed, additional patients (including patients who participate in the dose-escalation portion of this study) are accrued and randomized to 1 of 4 dose levels. All patients receive fenretinide and lonafarnib as in the dose-escalation portion of this study. NOTE: *Lonafarnib is not administered on day 1 of course 1. After completion of study treatment, patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck - Advanced or recurrent disease - Considered incurable by standard measures - Tumor tissue accessible for biopsy PATIENT CHARACTERISTICS: Age - Any age Performance status - stern Cooperative Oncology Group (ECOG) 0-1 Life expectancy - Not specified Hematopoietic - White Blood Count (WBC) ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 9.0 g/dL Hepatic - Bilirubin ≤ 2.0 mg/dL - Albumin ≥ 2.5 g/dL - Aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR - Alkaline phosphatase ≤ 4 times Upper Limit of Normal (ULN) AND Aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) normal Renal - Creatinine < 2 mg/dL Cardiovascular - No history of uncontrolled heart disease - No arrhythmia - No angina - No congestive heart failure - No other heart condition that cannot be controlled with regular ongoing medication Gastrointestinal - Able to swallow oral medication - No requirement for total parenteral nutrition with lipids Neurological - No significant neuropathy - No neurotoxicity ≥ grade 3 from prior anticancer treatment Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-method contraception during and for at least 1 month after study participation - No signs or symptoms of acute infection requiring systemic therapy - No confusion, disorientation, or major psychiatric illness that would preclude giving informed consent - No serious infection requiring immediate therapy - No other illness requiring immediate therapy - No pre-existing retinopathy - No other medical or social factor that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Chemotherapy Chemotherapy - No more than 2 prior chemotherapeutic regimens for recurrent or metastatic disease - Prior biologic therapy not considered a chemotherapeutic regimen Endocrine therapy - More than 2 days since prior and no concurrent high-dose chronic steroids - More than 2 days since prior and no concurrent ethinylestradiol - No concurrent anticancer hormonal therapy Radiotherapy - More than 6 months since prior radiotherapy - No concurrent radiotherapy Surgery - No prior surgery that may affect the ability to swallow study drugs Other - More than 2 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4) inducers or inhibitors, including any of the following: - Gestodene - Itraconazole - Ketoconazole - Cimetidine - Erythromycin - Carbamazepine - Phenobarbital - Phenytoin - Rifampin - Sulfinpyrazone - Grapefruit juice - More than 30 days since prior high-dose vitamin A - No concurrent high-dose synthetic or natural vitamin A derivatives (> 10,000 IU/day) - No concurrent antioxidants (e.g., vitamin E or vitamin C) - No other concurrent investigational agents - No other concurrent antineoplastic agents


NCT ID:

NCT00103090


Primary Contact:

Study Chair
Edward S. Kim
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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