Status:
TERMINATED
4-HPR and FTI in Head and Neck Squamous Cell Carcinoma (HNSCC)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Schering-Plough
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
Phase:
PHASE1
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 random...
Detailed Description
The drug fenretinide is a retinoid that is similar to vitamin A. It is believed that fenretinide can cause cancer cells to die. SCH66336 is a drug that blocks farnesyl protein transferase (a substance...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00102635
Start Date
January 20 2005
End Date
November 1 2006
Last Update
November 15 2018
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030