antineoplaston therapy in treating patients with stage iv adrenal gland cancer

Conditions: Stage IV Adrenocortical Carcinoma

Summary: current therapies for stage iv adrenal gland cancer 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 adrenal gland cancer purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with stage iv adrenal gland cancer.

overview: this is a single arm, open-label study in which patients with stage iv adrenal gland cancer 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 adrenal gland cancer, 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 adrenal gland cancer. * 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 confirmed stage iv adrenal gland carcinoma that is unlikely to respond to existing therapy and for which no curative therapy exists * measurable disease by mri or ct scan * tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the largest diameter for other localizations patient characteristics: age: * 6 months 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: * bilirubin no greater than 2.5 mg/dl * sgot/sgpt no greater than 5 times upper limit of normal * no hepatic failure renal: * creatinine no greater than 2.5 mg/dl * no history of renal conditions that contraindicate high dosages of sodium cardiovascular: * no severe heart disease * no uncontrolled hypertension * no history of congestive heart failure * no history of other cardiovascular conditions that contraindicate high dosages of sodium pulmonary: * no severe lung disease other: * not pregnant or nursing * fertile patients must use effective contraception during and for 4 weeks after study participation * no serious active infections or fever * no other concurrent serious disease prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy and recovered * no concurrent immunomodulating agents chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * no concurrent antineoplastic agents endocrine therapy: * concurrent corticosteroids allowed radiotherapy: * at least 8 weeks since prior radiotherapy and recovered surgery: * recovered from any prior operative procedure other: * no prior antineoplaston therapy * prior cytodifferentiating agent allowed

Keywords: recurrent adrenocortical carcinoma