Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00102635
Recruitment Status : Terminated (Slow accrual.)
First Posted : February 1, 2005
Last Update Posted : November 15, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Fenretinide (4-HPR) Drug: SCH66336 Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

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.
Other Names:
  • Lonafarnib
  • SCH 66336
  • Sarasar

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 21 day courses ]
    MTD derived from lack of dose limiting toxicities (DLT) in 4 differing dose levels.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has histologically proven squamous cell carcinoma of the head and neck which is biopsy accessible and is not considered curable by standard measures.
  • Patient has a Karnofsky performance status >/= 70%
  • Patient has adequate bone marrow function: *WBC >/= 3,000 cells/mm^3, *ANC >/= 1,500 cells/mm^3, *platelet count >/= 100,000 cells/mm^3, *Hgb >/= 9.0 g/dL.
  • Patient has adequate liver function: *total bilirubin level </= 2.0 mg/dL, *albumin >/= 2.5 g/dL.
  • Transaminases (SGOT and/or SGPT) may be up to 2.5 x ULN if alkaline phosphatase is </= ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are </= ULN.
  • Patient has adequate renal function: a serum creatinine < 2 mg/dl
  • Patient has signed a written informed consent.
  • Patient has received no more than 2 prior chemotherapeutic regimens for recurrent or metastatic disease. Prior biologic therapy is not included.

Exclusion Criteria:

  • Patient has received 3 or more prior chemotherapeutic regimens for recurrent/metastatic disease.
  • No biopsy accessible tissue.
  • Patient has received radiation therapy within the past 6 months.
  • Prior radiation to the biopsy site.
  • Patient has signs or symptoms of acute infection requiring systemic therapy.
  • Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient's understanding of the informed consent.
  • Patient has grade 3 or 4 neurotoxicity from previous anticancer treatment or significant neuropathy from any cause.
  • Patient requires total parenteral nutrition with lipids.
  • Surgery is anticipated to leave patient unable to swallow the SCH66336 or 4-HPR daily.
  • Patient has a history of uncontrolled heart disease (including arrhythmia, angina, congestive heart failure, or any heart condition that cannot be controlled with regular ongoing medication)
  • Because of the known teratogenic effect of retinoids, pregnant women and women who are currently breast-feeding may not participate in this study. All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study.
  • Serious infection or other intercurrent illness requiring immediate therapy.
  • Inability to swallow oral medications, or other medical or social factors interfering with compliance.
  • Patients may not take high dose synthetic or natural Vitamin A derivatives (>10,000 IU per day). Patients may not be taking high-dose vitamin A within 30 days of study entry.
  • Patients should not take any anti-oxidants such as Vitamin E or Vitamin C
  • Patients with pre-existing retinopathy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00102635

Layout table for location information
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Edward S Kim, MD M.D. Anderson Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00102635    
Obsolete Identifiers: NCT00103090
Other Study ID Numbers: ID01-455
First Posted: February 1, 2005    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Keywords provided by M.D. Anderson Cancer Center:
apoptotic activity
Farnesyl Transferase Inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action