Antineoplaston Therapy in Treating Women With Advanced Breast Cancer

July 9, 2013 updated by: Burzynski Research Institute

Phase II Study of Oral Antineoplastons A10 and AS2-1 in Women With Advanced Breast Cancer

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 is studying how well antineoplaston therapy works in treating women with stage IV breast cancer that has not responded to standard therapy.

Study Overview

Detailed Description

OBJECTIVES:

  • Determine the antitumor activity of antineoplastons A10 and AS2-1 capsules in patients with advanced breast cancer by determining the proportion of women who experience an objective tumor response.
  • Evaluate the adverse effects of and tolerance to this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive oral antineoplaston A10 and antineoplaston AS2-1 6 to 7 times per day.

Treatment continues for at least 6 weeks. Patients achieving complete or partial response may continue on therapy until disease progression or toxic effects occur.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77055-6330
        • Burzynski Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV breast cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
  • 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 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 failure

Cardiovascular:

  • No chronic heart failure
  • No uncontrolled hypertension

Pulmonary:

  • No severe lung 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
  • No serious malabsorption syndromes

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Recovered from prior immunotherapy
  • At least 4 weeks since prior immunotherapy, except in patients with disease progression during or after initial therapy

Chemotherapy:

  • Recovered from prior chemotherapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in patients with disease progression during or after initial therapy

Endocrine therapy:

  • Recovered from prior hormonal therapy
  • At least 12 weeks since prior hormonal therapy, except in patients with disease progression during and after initial therapy
  • Concurrent corticosteroids for peritumoral edema allowed

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
  • No prior extensive stomach or intestinal surgery

Other:

  • Prior cytodifferentiating agents allowed
  • No prior antineoplaston therapy
  • No other concurrent therapy for metastatic breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 9, 2013

Last Verified

December 1, 2006

More Information

Terms related to this study

Other Study ID Numbers

  • BC-BR-14
  • CDR0000066487 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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