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

NCT00102635 | Terminated Phase 1 DMC

• 1 other identifier: ID01-455
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

apoptotic activity; 4-HPR; FTI; Fenretinide; SCH66336; Farnesyl Transferase Inhibitor; HNC

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  MTD derived from lack of dose limiting toxicities (DLT) in 4 differing dose levels.

  21 day courses

Study Arms (1)

4-HPR + FTI

EXPERIMENTAL

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); Drug: SCH66336

Interventions

Fenretinide (4-HPR) DRUG

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

4-HPR + FTI

SCH66336 DRUG

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.

Also known as: Lonafarnib, SCH 66336, Sarasar

4-HPR + FTI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Schering-Plough: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Fenretinide; lonafarnib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Edward S Kim, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2005
• First Posted: February 1, 2005
• Study Start: January 20, 2005
• Primary Completion: January 1, 2006
• Study Completion: November 1, 2006
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

US (1)