Clinical trial · Interventional
4-HPR and FTI in Head and Neck Squamous Cell Carcinoma (HNSCC)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fenretinide (4-HPR) | Drug | — | UNRESOLVED |
| SCH66336 | Drug | Lonafarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 4-HPR + FTI
- description
- 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.
- interventionNames
- Drug: Fenretinide (4-HPR)
- Drug: SCH66336
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 21 day courses
- description
- MTD derived from lack of dose limiting toxicities (DLT) in 4 differing dose levels.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available