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4-HPR and FTI in Head and Neck Squamous Cell Carcinoma (HNSCC)

NCT00102635 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-11-15

No results posted yet for this study

Summary

The primary objective of this study is to estimate the modulation of intermediate biological endpoints of the combination of 4-HPR and SCH66336, a farnesyl transferase inhibitor (FTI), across 4 randomly assigned dose levels in patients with locally advanced or recurrent head and neck cancer. We will also assess the activity, safety, tolerability and side effects of 4-HPR/SCH66336 and hope to establish a phase II regimen.

Conditions

Interventions

DRUG

Fenretinide (4-HPR)

Oral 100 mg capsules in two divided doses at least 8 hours apart for 7 days each cycle.

DRUG

SCH66336

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Schering-Plough

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Edward S Kim, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-20
Primary Completion
2006-01-31
Completion
2006-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00102635 on ClinicalTrials.gov