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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003443
First received: November 1, 1999
Last updated: June 20, 2013
Last verified: June 2013

November 1, 1999
June 20, 2013
July 1998
May 2001   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003443 on ClinicalTrials.gov Archive Site
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Bryostatin 1 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
A Phase II Trial of Bryostatin-1 In Patients With Metastatic or Recurrent Squamos Cell Carcinoma of the Head and Neck

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Head and Neck Cancer
Drug: bryostatin 1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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May 2001
May 2001   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003443
98-042, CDR0000066471, NCI-T97-0095
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: David G. Pfister, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP