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

This study is currently recruiting patients.

Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)


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 Treatment or Intervention Phase
stage IV breast cancer
recurrent breast cancer
 Drug: antineoplaston A10
 Drug: methotrexate
 Procedure: alternative product therapy
 Procedure: biological response modifier therapy
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: chemotherapy
 Procedure: complementary and alternative therapy
 Procedure: differentiation therapy
Phase II

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

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

Further Study Details: 


  • 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.


Genders Eligible for Study:  Both




  • 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



Endocrine therapy:



  • Not specified


Location and Contact Information

      Burzynski Clinic, Houston,  Texas,  77055-6330,  United States; Recruiting
Stanislaw R. Burzynski, MD, PhD  713-335-5697 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066584; BC-BR-10; NCT00003536
Record last reviewed:  September 2003
Last Updated:  February 9, 2005
Record first received:  November 1, 1999 Identifier:  NCT00003536
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005