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

Primary Purpose

Stage IV Breast Cancer, Recurrent Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
antineoplaston A10
methotrexate
alternative product therapy
biological therapy
biologically based therapies
cancer prevention intervention
chemotherapy
complementary and alternative therapy
differentiation therapy
Sponsored by
Burzynski Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Burzynski Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 9, 2013
Sponsor
Burzynski Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00003536
Brief Title
Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
Official Title
Phase II Randomized Study of Methotrexate With or Without Antineoplaston A10 Capsules in Women With Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Burzynski Research Institute

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Breast Cancer, Recurrent Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
antineoplaston A10
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Procedure
Intervention Name(s)
alternative product therapy
Intervention Type
Procedure
Intervention Name(s)
biological therapy
Intervention Type
Procedure
Intervention Name(s)
biologically based therapies
Intervention Type
Procedure
Intervention Name(s)
cancer prevention intervention
Intervention Type
Procedure
Intervention Name(s)
chemotherapy
Intervention Type
Procedure
Intervention Name(s)
complementary and alternative therapy
Intervention Type
Procedure
Intervention Name(s)
differentiation therapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislaw R. Burzynski, MD, PhD
Organizational Affiliation
Burzynski Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Burzynski Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77055-6330
Country
United States

12. IPD Sharing Statement

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

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