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Bryostatin 1 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
This study has been completed.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003443
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: bryostatin 1
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Bryostatin 1
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of Bryostatin-1 In Patients With Metastatic or Recurrent Squamos Cell Carcinoma of the Head and Neck

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1998
Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003443

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David G. Pfister, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000066471, MSKCC-98042, NCI-T97-0095
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003443  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Study placed in the following topic categories:
Epidermoid carcinoma
Nasopharyngeal carcinoma
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Bryostatin 1
Carcinoma, Squamous Cell
Recurrence
Dental Caries
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009