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

This study has been terminated.
(Slow accrual.)
Sponsor:
Collaborators:
Schering-Plough
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00102635
First received: January 31, 2005
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: Fenretinide (4-HPR)
Drug: SCH66336
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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


Enrollment: 1
Study Start Date: January 2005
Study Completion Date: November 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102635

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Schering-Plough
Investigators
Principal Investigator: Edward S Kim, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00102635     History of Changes
Other Study ID Numbers: ID01-455
Study First Received: January 31, 2005
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
apoptotic activity
4-HPR
FTI
Fenretinide
SCH66336
Farnesyl Transferase Inhibitor
HNC

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Fenretinide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014