antineoplaston therapy in treating patients with metastatic or unresectable colon cancer

Conditions: Colon Cancer

Summary: current therapies for metastatic or unresectable colon 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 metastatic or unresectable colon cancer. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with metastatic or unresectable colon cancer

overview: this is a single arm, open-label study in which patients with metastatic or unresectable colon cancer 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 metastatic or unresectable colon 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 metastatic or unresectable colon 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 adenocarcinoma of the colon that is unlikely to respond to existing therapy and for which no curative therapy exists * metastatic or unresectable disease * measurable disease by ct scan or mri 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: * 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 renal failure * no history of renal conditions that contraindicate high dosages of sodium cardiovascular: * no 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 during and for 4 weeks after study participation * no active infection * no other serious concurrent disease 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 agents endocrine therapy: * concurrent corticosteroids allowed radiotherapy: * at least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors may be admitted earlier) surgery: * recovered from prior surgery other: * prior cytodifferentiating agent allowed * no prior antineoplaston therapy

Keywords: stage iv colon cancer unresectable colon cancer