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A Phase II Trial of Bryostatin-1 In Patients With Metastatic or Recurrent Squamos Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

A Phase II Trial of Bryostatin-1 In Patients With Metastatic or Recurrent Squamos Cell Carcinoma of the Head and Neck


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David G. Pfister, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-042

NCT ID:

NCT00003443

Start Date:

July 1998

Completion Date:

May 2001

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021