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

NCT00003536 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-07-10

No results posted yet for this study

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.

Conditions

  • Stage IV Breast Cancer
  • Recurrent Breast Cancer

Interventions

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

Sponsors & Collaborators

  • Burzynski Research Institute

    lead OTHER

Principal Investigators

  • Stanislaw R. Burzynski, MD, PhD · Burzynski Research Institute

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003536 on ClinicalTrials.gov