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Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003454
First Posted: January 27, 2003
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Burzynski Research Institute
November 1, 1999
January 27, 2003
September 28, 2017
March 18, 1996
December 28, 2002   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003454 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Breast

RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.

PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating women who have stage IV breast cancer that has not responded to previous therapy.

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV breast cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in patients with Stage IV breast cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
  • To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV breast cancer.
  • To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Stage IV Breast Cancer
Drug: Antineoplaston therapy (Atengenal + Astugenal)

Patients with Stage IV Breast Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Other Name: A10 (Atengenal); AS2-1 (Astugenal)
Experimental: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Intervention: Drug: Antineoplaston therapy (Atengenal + Astugenal)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
19
December 28, 2002
December 28, 2002   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV breast cancer that is unlikely to respond to existing therapy and for which no curative therapy exists

    • Must have failed prior standard therapy
  • Measurable disease by MRI or CT scan
  • Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal Status:

  • Not specified

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC at least 2,000/mm^3
  • Platelet count at least 50,000/mm^3

Hepatic:

  • Bilirubin nor greater than 2.5 mg/dL
  • SGOT/SGPT no greater than 5 times upper limit of normal
  • No hepatic failure

Renal:

  • Creatinine no greater than 2.5 mg/dL
  • No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

  • No chronic heart failure
  • No uncontrolled hypertension
  • No history of congestive heart failure
  • No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

  • No severe lung disease, such as chronic obstructive pulmonary disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No serious medical or psychiatric disorders
  • No active infections
  • No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy, except in patients with disease progression during or after initial therapy
  • Recovery from prior immunotherapy
  • No concurrent immunomodulating agents

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in patients with disease progression during or after initial therapy
  • Recovery from prior chemotherapy
  • No concurrent antineoplastic agents

Endocrine therapy:

  • At least 12 weeks since prior hormonal therapy, except in patients with disease progression during and after initial therapy
  • Concurrent corticosteroids allowed
  • Recovery from prior hormonal therapy

Radiotherapy:

  • At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks)

Surgery:

  • Recovered from any prior surgery

Other:

  • No prior antineoplaston therapy
  • Prior cytodifferentiating agent allowed
Sexes Eligible for Study: Female
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003454
CDR0000066486
BC-BR-12 ( Other Identifier: Burzynski Research Institute )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Burzynski Research Institute
Burzynski Research Institute
Not Provided
Principal Investigator: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
Burzynski Research Institute
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP