Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer

Phase 2TerminatedNCT00003533

Burzynski Research Institute12 enrolled

Overview

Current therapies for Metastatic Pancreatic 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 Pancreatic Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Metastatic Pancreatic Cancer.

Metastatic Pancreatic Cancer 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 Metastatic Pancreatic 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 Pancreatic 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Prostate Cancer

Interventions

Antineoplaston therapy (Atengenal + Astugenal)DRUG

Patients with Metastatic Pancreatic Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically proven incurable, metastatic, hormone-refractory adenocarcinoma of the prostate that is unlikely to respond to existing therapy * Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan * Stage D2 PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * Hemoglobin at least 9 g/dL * 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: * Creatinine no greater than 2.5 mg/dL * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No known 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 severe chronic obstructive pulmonary disease Other: * Fertile patients must use effective contraception during and for 4 weeks after study participation * Not a high medical or psychiatric risk * No concurrent nonmalignant systemic disease * No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * At least 4 weeks since prior hormonal therapy (unless progression documented upon discontinuation of hormones) * Concurrent corticosteroids allowed, if stable or decreasing for at least 2 months before study entry Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * Recovered from prior surgery Other: * Prior cytodifferentiating agent allowed

Locations (1)

Burzynski Clinic

Houston, Texas, United States

Data from ClinicalTrials.gov

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