antineoplaston therapy in treating patients with neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy

Conditions: Merkel Cell Carcinoma; Islet Cell Carcinoma; Neuroendocrine Carcinoma; Pituitary Tumor

Summary: rationale: antineoplastons are naturally-occurring substances that may also be made in the laboratory. antineoplastons may inhibit the growth of cancer cells. purpose: this phase ii trial is studying how well antineoplaston therapy works in treating patients with neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.

objectives: * provide treatment with antineoplastons a10 and as2-1 for patients with metastatic or incurable neuroendocrine tumors. * describe response, tolerance to, and side effects of this regimen in these patients. outline: this is an open-label study. patients receive gradually escalating doses of antineoplastons a10 and as2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. patients achieving complete response (cr) continue treatment for an additional 8 months after reaching 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.

Eligibility criteria:
disease characteristics: * histologically confirmed incurable neuroendocrine tumor that is unlikely to respond to existing therapy, meeting 1 of the following criteria: * metastatic disease * disease that is not curable with surgery or radiotherapy * 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 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 during and for 4 weeks after study participation * no active infection * no concurrent nonmalignant systemic disease * not a high medical or psychiatric risk prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy * no concurrent immunomodulating agents chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) endocrine therapy: * concurrent corticosteroids allowed radiotherapy: * at least 8 weeks since prior radiotherapy surgery: * recovered from prior surgery other: * prior cytodifferentiating agents allowed * no prior antineoplastons * no other concurrent antineoplastic agents

Keywords: acth-producing pituitary tumor prolactin-producing pituitary tumor growth hormone-producing pituitary tumor recurrent pituitary tumor tsh producing pituitary tumor nonfunctioning pituitary tumor somatostatinoma stage iii merkel cell carcinoma recurrent merkel cell carcinoma neuroendocrine carcinoma