4-HPR and FTI in Head and Neck Squamous Cell Carcinoma (HNSCC)
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|ClinicalTrials.gov Identifier: NCT00102635|
Recruitment Status : Terminated (Slow accrual.)
First Posted : February 1, 2005
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Fenretinide (4-HPR) Drug: SCH66336||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IB Randomized Translational Study of Fenretinide (4-HPR) in Combination With SCH66336, a Farnesyl Transferase Inhibitor, in Patients With Advanced or Recurrent Head and Neck Cancer|
|Actual Study Start Date :||January 20, 2005|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||November 2006|
Experimental: 4-HPR + FTI
SCH66336 daily for 21 days each cycle and with 4-HPR daily on days 1-7 only. On day 1 of cycle 1, 4-HPR only beginning SCH66336 on day 2 of cycle 1.
Drug: Fenretinide (4-HPR)
Oral 100 mg capsules in two divided doses at least 8 hours apart for 7 days each cycle.
Oral capsules with 50 mg, 75 mg, or 100 mg formulation in two divided doses at least 8 hours apart for 21 days each cycle.
- Maximum Tolerated Dose (MTD) [ Time Frame: 21 day courses ]MTD derived from lack of dose limiting toxicities (DLT) in 4 differing dose levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102635
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Edward S Kim, MD||M.D. Anderson Cancer Center|