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Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer


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

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Trial Information

Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer


OBJECTIVES:

- Compare the antitumor activity of antineoplaston A10 with methotrexate vs methotrexate
alone, in terms of objective tumor response, in women with advanced breast cancer.

- Compare the adverse effects of and tolerance to these regimens in these patients.

OUTLINE: This is a randomized study.

- Arm I: Patients receive gradually escalating doses of oral antineoplaston A10 capsules
7 times daily until the maximum tolerated dose is reached, followed by oral
methotrexate capsules 2 to 3 times per day in five days on and five days off courses.
Treatment continues in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive oral methotrexate alone on the same schedule as in arm I.

Tumors are measured every 4 months for 2 years, every 6 months for years 3 and 4, and then
annually for years 5 and 6.

PROJECTED ACCRUAL: A total of 30-70 patients will be accrued for this study within at least
12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed advanced breast cancer that is refractory or unlikely to
respond to hormonal therapy AND failed at least 1 prior chemotherapy regimen

- Symptomatic lymphangitic pulmonary dissemination allowed

- Extensive visceral metastasis allowed

- Patients who are refractory or who have failed to respond after at least 8 weeks of
methotrexate or a methotrexate-containing regimen are not eligible

- Measurable disease

- No bone metastases

- Hormone receptor status:

- Estrogen receptor negative

PATIENT CHARACTERISTICS:

Age:

- Postmenopausal

Sex:

- Female

Menopausal status:

- Postmenopausal

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

- SGOT no greater than 2 times normal

- Blood ammonia normal

- No hepatic failure

Renal:

- BUN less than 60 mg/dL

- Creatinine no greater than 2.5 mg/dL

- Creatinine clearance greater than 60 mL/min

- No chronic renal failure

Cardiovascular:

- No severe heart disease

Pulmonary:

- No severe lung disease

Other:

- No serious active infections or fever

- No other concurrent serious disease

- No prior or concurrent secondary malignancies within the past 2 years

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent biologic therapy for metastatic breast cancer

Chemotherapy:

- See Disease Characteristics

- At least 4 weeks since prior cytotoxic chemotherapy and recovered

- No other concurrent chemotherapy for metastatic breast cancer

Endocrine therapy:

- See Disease Characteristics

- At least 4 weeks since prior hormonal therapy and recovered

- No concurrent hormonal therapy for metastatic breast cancer

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy for metastatic breast cancer

Surgery:

- Not specified

Other:

- At least 4 weeks since prior participation in experimental clinical trials

- No prior antineoplaston A10 therapy

- No other concurrent treatment for metastatic breast cancer

- No concurrent salicylates, nonsteroidal anti-inflammatory drugs, phenylbutazone,
phenytoin, and sulfonamides

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:

CDR0000066584

NCT ID:

NCT00003536

Start Date:

Completion Date:

Related Keywords:

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

Name

Location

Burzynski ClinicHouston, Texas  77055-6330