- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003536
Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: methotrexate
- Procedure: biological therapy
- Procedure: chemotherapy
- Drug: antineoplaston A10
- Procedure: alternative product therapy
- Procedure: biologically based therapies
- Procedure: cancer prevention intervention
- Procedure: complementary and alternative therapy
- Procedure: differentiation therapy
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Texas
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Houston, Texas, United States, 77055-6330
- Burzynski Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- BC-BR-10
- CDR0000066584 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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