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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This study has been withdrawn prior to recruitment.
First Received: November 1, 1999   Last Updated: December 4, 2006   History of Changes
Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003536
  Purpose

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 II

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

Resource links provided by NLM:


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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003536

Locations
United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Investigators
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066584, BC-BR-10
Study First Received: November 1, 1999
Last Updated: December 4, 2006
ClinicalTrials.gov Identifier: NCT00003536     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Antimetabolites
Skin Diseases
Immunologic Factors
Breast Neoplasms
Folate
Folic Acid Antagonists
Folinic Acid
Immunosuppressive Agents
Vitamin B9
Recurrence
Folic Acid
Methotrexate
Antirheumatic Agents
Breast Diseases

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Abortifacient Agents
Methotrexate
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on September 01, 2009