Clinical trial NCT00102635 (phase 1, status: terminated)
Conditions: head and neck cancer
ICD codes: C76.0, C47.0, C49.0, C77.0, D17.0, D21.0, D36.11
Drugs: fenretinide (4-hpr), sch66336
SMILES: C\C(\C=C\C1=C(C)CCCC1(C)C)=C/C=C/C(/C)=C/C(=O)NC1=CC=C(O)C=C1, NC(=O)N1CCC(CC(=O)N2CCC(CC2)[C@H]2C3=C(CCC4=C2C(Br)=CC(Cl)=C4)C=C(Br)C=N3)CC1
Reason stopped: 
    slow accrual.
  
Eligibility 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