Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Head and Neck
16 Years
N/A
Both
Head and Neck Cancer
Trial Information
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Head and Neck
OBJECTIVES:
- Provide treatment with antineoplastons A10 and AS2-1 to patients with incurable cancer
of the head and neck.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1
by intravenous injection six times per day until the maximum tolerated dose is reached.
Treatment continues for at least 2 months in the absence of disease progression or
unacceptable toxicity. After 2 months, patients with stable or responding disease may
continue treatment. Patients achieving complete response (CR) continue treatment for 8
months beyond CR.
Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed cancer of the head and neck that is unlikely to respond to
existing therapy and for which no curative therapy exists
- Metastatic disease OR incurable with surgery or radiation
- Measurable disease by CT scan or MRI
- Tumor must be at least 2 cm for the lymph nodes located in the head, neck,
axillary, inguinal or femoral areas and at least 0.5 cm for other areas
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic:
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 2.5 mg/dL
Renal:
- No renal insufficiency
- Creatinine no greater than 2.5 mg/dL
- No renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No chronic heart failure
- No uncontrolled hypertension
- No history of congestive heart failure
- No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No serious lung disease (e.g., severe chronic obstructive pulmonary disease)
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study
participation
- No other serious medical or psychiatric conditions
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulatory agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent antineoplastic therapy
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 8 weeks since prior radiotherapy (unless multiple tumors) and recovered
Surgery:
- See Disease Characteristics
Other:
- Prior cytodifferentiating agents allowed
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Stanislaw R. Burzynski, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Burzynski Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000066527
NCT ID:
NCT00003489
Start Date:
August 1998
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage IV salivary gland cancer
- recurrent salivary gland cancer
- recurrent lymphoepithelioma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- stage IV lymphoepithelioma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent verrucous carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage IV verrucous carcinoma of the larynx
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent inverted papilloma of the paranasal sinus and nasal cavity
- recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent lymphoepithelioma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage IV lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- recurrent verrucous carcinoma of the oral cavity
- stage IV verrucous carcinoma of the oral cavity
- recurrent adenoid cystic carcinoma of the oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- recurrent mucoepidermoid carcinoma of the oral cavity
- stage IV mucoepidermoid carcinoma of the oral cavity
- recurrent basal cell carcinoma of the lip
- stage IV basal cell carcinoma of the lip
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Burzynski Clinic | Houston, Texas 77055-6330 |
