Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Advanced Head and Neck Cancer, Recurrent Head and Neck Cancer, Oral Cavity Cancer, Nasopharyngeal Cancer, Hypopharyngeal Cancer, Laryngeal Cancer, Nasal Cavity Cancer, Paranasal Sinus Cancer, Oropharyngeal Cancer, Salivary Gland Cancer, Stage IV Head and Neck Cancer
Eligibility 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
Sites / Locations
- Burzynski Clinic
Arms of the Study
Arm 1
Experimental
Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.