antineoplaston therapy in treating patients with recurrent or extensive-stage small cell lung cancer

Conditions: Small Cell Lung Cancer Extensive Stage

Summary: current therapies for recurrent or extensive-stage small cell lung 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 recurrent or extensive-stage small cell lung cancer. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with recurrent or extensive-stage small cell lung cancer.

overview: this is a single arm, open-label study in which patients with recurrent or extensive-stage small cell lung 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 recurrent or extensive-stage small cell lung 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 recurrent or extensive-stage small cell lung 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 recurrent or extensive stage small cell lung cancer unlikely to have a curative response to existing standard regimens * measurable disease by mri or ct scan * at least 2 cm in diameter 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 insufficiency * 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 (e.g., 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 infections * 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 prior surgery other: * no prior antineoplaston therapy * prior cytodifferentiating agent allowed

Keywords: recurrent small cell lung cancer