RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with metastatic or recurrent head and neck cancer.

Condition	Treatment or Intervention	Phase
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the hypopharynx	Drug: bryostatin 1	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate the antitumor activity of bryostatin 1 in chemotherapy naive patients with metastatic or recurrent head and neck squamous cell carcinoma, not curable with surgery or radiation therapy. II. Evaluate the safety and toxicity of bryostatin 1 when administered in the prescribed schedule in this patient population. III. Assess cyclin dependent kinase 2 activity, protein kinase C activity, and apoptosis measurements in selected patients with tumors accessible for biopsy following bryostatin 1 therapy.

PROTOCOL OUTLINE: Patients receive bryostatin 1 IV over 24 hours once weekly for three weeks followed by one week of rest. Treatment is continued every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients with stable disease after two courses may continue treatment or stop treatment at the discretion of the treating physician.

PROJECTED ACCRUAL: There will be 14-25 patients accrued into this study over 1-2 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed metastatic or recurrent squamous cell carcinoma of the oral cavity, lip, hypopharynx, oropharynx, nasopharynx, paranasal sinuses, nasal cavity, nostril, or larynx that is not curable by surgery or radiation therapy
• Must have one or more measurable indicator lesions; Bone metastases, brain metastases, elevated enzyme levels and lesions on radionuclide scans are not acceptable as the sole parameters of measurable disease

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: One prior chemotherapy regimen as part of a locoregional treatment (e.g., induction/concomitant) allowed, either as primary treatment or as therapy for locoregional relapse, if relapse occurred more than 6 months later; No other prior chemotherapy; Prior chemoprevention agents (e.g., cisretinoic acid or other vitamin analogues) allowed
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy; No prior radiotherapy to more than 50% of bone marrow-bearing bones
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 60-100%
• Life expectancy: Not specified
• Hematopoietic: WBC greater than 4,000/mm3; Platelet count greater than 100,000/mm3
• Hepatic: Bilirubin less than 1.5 mg/dL; Transaminases (SGOT/SGPT) less than 2.5 times upper limit of normal
• Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min
• Cardiovascular: No unstable cardiac rhythm
• Other: No active infection requiring antibiotics; No concurrent medical condition that makes participation in this study medically unsafe; No other prior malignancy in the last 2 years except basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or metachronous/synchronous epidermoid/squamous cell cancers of the head and neck; Not pregnant or nursing; Effective contraception required of all fertile patients

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

David G. Pfister,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000066471; MSKCC-98042; NCI-T97-0095
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003443
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08