Spots Global Cancer Trial Database for Antineoplaston Therapy in Treating Patients With Stage IV Melanoma

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Trial Identification

Brief Title: Antineoplaston Therapy in Treating Patients With Stage IV Melanoma

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Malignant Melanoma

Study ID: NCT00003509

Conditions

Stage IV Melanoma

Interventions

Antineoplaston therapy (Atengenal + Astugenal)

Study Description

Brief Summary: Current therapies for Stage IV Melanoma 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 Melanoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Melanoma.

Detailed Description: Stage IV Melanoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with Stage IV Melanoma, 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 Melanoma. * 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.