Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva
Cervical Cancer Stage IV, Vulvar Cancer, Stage IV
About this trial
This is an interventional treatment trial for Cervical Cancer Stage IV focused on measuring recurrent cervical cancer, recurrent vulvar cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven incurable stage IV carcinoma of the uterine cervix and/or vulva that is unlikely to respond to existing therapy Measurable disease by MRI or CT scan Tumor must be at least 2 cm PATIENT CHARACTERISTICS: Age: 18 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 5 times upper limit of normal Renal: No renal insufficiency Creatinine no greater than 2.5 mg/dL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No known chronic heart failure No uncontrolled hypertension No history of congestive heart failure No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease, such as chronic obstructive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception Not a high medical or psychiatric risk No concurrent nonmalignant systemic disease 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 Endocrine therapy: At least 1 month since prior tamoxifen if no progression May enter study immediately if evidence of progression Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy and recovered Surgery: Recovered from prior surgery Other: Prior cytodifferentiating agents allowed No prior antineoplastons No other concurrent antineoplastic agents
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.