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


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage IV Breast Cancer, Recurrent Breast Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stanislaw R. Burzynski, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Burzynski Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066487

NCT ID:

NCT00003455

Start Date:

Completion Date:

Related Keywords:

  • Stage IV Breast Cancer
  • Recurrent Breast Cancer
  • Breast Neoplasms

Name

Location

Burzynski ClinicHouston, Texas  77055-6330