antineoplaston therapy in treating patients with stage iv cancer of the cervix and/or vulva

Conditions: Cervical Cancer Stage IV; Vulvar Cancer, Stage IV

Summary: current therapies for stage iv cancer of the cervix and/or vulva provide very limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of stage iv cancer of the cervix and/or vulva. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with stage iv cancer of the cervix and/or vulva.

stage iv cancer of the cervix and/or vulva patients receive gradually escalating doses of intravenous antineoplaston therapy (atengenal + astugenal) until the maximum tolerated dose is reached. treatment continues up to12 months in the absence of disease progression or unacceptable toxicity. objectives: * to determine the efficacy of antineoplaston therapy in patients with stage iv cancer of the cervix and/or vulva, as measured by an objective response to therapy (complete response, partial response or stable disease). * to determine the safety and tolerance of antineoplaston therapy in patients with stage iv cancer of the cervix and/or vulva. * to determine objective response, tumor size is measured utilizing mri scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

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

Keywords: recurrent cervical cancer recurrent vulvar cancer