Overview

Bryostatin 1 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Status:
Completed

Trial end date:
2001-05-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Memorial Sloan Kettering Cancer Center

Collaborator:

National Cancer Institute (NCI)

Treatments:

Bryostatin 1

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

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

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