Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003454
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: April 2004
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Breast

Resource links provided by NLM:


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

Estimated Enrollment: 40
Study Start Date: August 1998
Detailed Description:

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in women with stage IV breast carcinoma.
  • Describe the response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured at least every 2 months for 1 year and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003454

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

ClinicalTrials.gov Identifier: NCT00003454     History of Changes
Other Study ID Numbers: CDR0000066486, BC-BR-12
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014