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Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer

This study has been withdrawn prior to enrollment.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: July 9, 2013
Last verified: December 2006

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Antineoplastons are naturally occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. It is not yet known whether giving antineoplastons with chemotherapy is more effective than chemotherapy alone in treating women with refractory breast cancer.

PURPOSE: This randomized phase II trial is studying methotrexate alone to see how well it works campared to methotrexate and antineoplaston therapy in treating postmenopausal women with advanced refractory breast cancer.

Condition Intervention Phase
Stage IV Breast Cancer Recurrent Breast Cancer Drug: antineoplaston A10 Drug: methotrexate Procedure: alternative product therapy Procedure: biological therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: chemotherapy Procedure: complementary and alternative therapy Procedure: differentiation therapy Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Enrollment: 0
Detailed Description:


  • 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Postmenopausal


  • Female

Menopausal status:

  • Postmenopausal

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months


  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2.5 mg/dL
  • SGOT no greater than 2 times normal
  • Blood ammonia normal
  • No hepatic failure


  • 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


  • No severe heart disease


  • No severe lung disease


  • 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


Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent biologic therapy for metastatic breast cancer


  • 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


  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy for metastatic breast cancer


  • Not specified


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00003536

United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information Identifier: NCT00003536     History of Changes
Other Study ID Numbers: BC-BR-10
CDR0000066584 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: November 1, 1999
Last Updated: July 9, 2013

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors processed this record on September 21, 2017