Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

Phase 2TerminatedNCT00003454

Burzynski Research Institute19 enrolled

Overview

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 studies the effectiveness of antineoplaston therapy in treating women who have stage IV breast cancer that has not responded to previous therapy.

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV breast 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 Stage IV breast 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 Stage IV breast 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

Stage IV Breast Cancer

Interventions

Antineoplaston therapy (Atengenal + Astugenal)DRUG

Patients with Stage IV Breast 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: FEMALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV breast cancer that is unlikely to respond to existing therapy and for which no curative therapy exists * Must have failed prior standard therapy * Measurable disease by MRI or CT scan * Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal Status: * Not specified 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 nor 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 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 severe 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 serious medical or psychiatric disorders * No active infections * No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy, except in patients with disease progression during or after initial therapy * Recovery from prior immunotherapy * No concurrent immunomodulating agents Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in patients with disease progression during or after initial therapy * Recovery from prior chemotherapy * No concurrent antineoplastic agents Endocrine therapy: * At least 12 weeks since prior hormonal therapy, except in patients with disease progression during and after initial therapy * Concurrent corticosteroids allowed * Recovery from prior hormonal therapy Radiotherapy: * At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks) Surgery: * Recovered from any prior surgery Other: * No prior antineoplaston therapy * Prior cytodifferentiating agent allowed

Locations (1)

Burzynski Clinic

Houston, Texas, United States

Data from ClinicalTrials.gov

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