Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	BC-BR-12 NCT00003454

Objectives

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

Entry 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

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

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/mm³
• Platelet count at least 50,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Burzynski Clinic

Stanislaw Burzynski, MD, PhD, Protocol chair		Ph: 713-335-5697

Registry Information
Official Title		Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Breast
Trial Start Date		1998-08-03
Registered in ClinicalTrials.gov		NCT00003454
Date Submitted to PDQ		1998-08-03
Information Last Verified		2004-04-08

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