Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

Stage IV Breast Cancer Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Breast

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003454
• Other study ID #: CDR0000066486
• Secondary ID: BC-BR-12
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: September 26, 2017
• Start date: March 18, 1996
• Est. completion date: December 28, 2002

Study information

• Verified date: September 2017
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 28, 2002
• Est. primary completion date: December 28, 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage IV Breast Cancer

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
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.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

External Links

•   Burzynski Clinic
•   Burzynski Research Institute