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

Alternate Title

Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	BC-RN-2 NCT00003520

Objectives

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

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage IV adenocarcinoma or transitional cell carcinoma of the kidney that is unlikely to respond to existing therapy



• Measurable disease by MRI or CT scan



• Tumor must be more than 2 cm for lymph nodes in head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm for other locations

Prior/Concurrent Therapy:

Biologic therapy:

• At least 4 weeks since prior immunotherapy
• No concurrent immunomodulatory agents

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Recovered from prior surgery

Other:

• Prior cytodifferentiating agents allowed
• No prior antineoplastons

Patient Characteristics:

Age:

• 18 and over

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:

• No hepatic insufficiency
• Bilirubin no greater than 2.5 mg/dL
• SGOT and SGPT no greater than 5 times upper limit of normal

Renal:

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

Cardiovascular:

• No known 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
• Not a high medical or psychiatric risk
• No concurrent nonmalignant systemic disease that would preclude therapy
• No active infection

Expected Enrollment

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

Outline

This is an open-label study.

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 achieving CR.

Tumors are measured every 2 months for 1 year and 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 Kidney
Trial Start Date		1998-08-06
Registered in ClinicalTrials.gov		NCT00003520
Date Submitted to PDQ		1998-08-06
Information Last Verified		2004-04-08

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