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

Alternate Title

Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other	BC-LY-6 NCT00003499

Objectives

1. Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening low grade non-Hodgkin's lymphoma.
2. Describe the response, tolerance to, and side effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven stage II, III, or IV low grade non-Hodgkin's lymphoma that is unlikely to respond to existing therapy or for which no established therapy exists

 [Note: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]

Prior/Concurrent Therapy:

Biologic therapy:

• At least 4 weeks since immunotherapy and recovered
• No concurrent immunomodulating agents (e.g., interferon, interleukin-2)

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

• At least 4 weeks since prior corticosteroids
• No concurrent corticosteroids

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Other:

• No prior antineoplaston therapy
• No other concurrent antineoplastic agents
• No concurrent antibiotics, antifungals, or antivirals

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC greater than 2,000/mm³
• Platelet count greater than 20,000/mm³

Hepatic:

• Bilirubin normal

Renal:

• Creatinine normal
• No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

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

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 4 weeks after study
• No serious active infections

Expected Enrollment

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

Outcomes

Response rate based on tumor measurements taken at 12 weeks

Survival at 1, 2, and 5 years from the start of treatment

Outline

This is an open label study.

Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression and unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.

Tumors are measured every 8 weeks for the first 6 months, every 3 months for the first 2 years, every 6 months for years 3 and 4, and yearly for years 5 and 6.

Trial Contact Information

Trial Lead Organizations

Burzynski Clinic

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

U.S.A.
Texas
	Houston
	Burzynski Clinic
		Stanislaw Burzynski, MD, PhD	Ph:  713-335-5697
			Email: info@burzynskiclinic.com

Registry Information
Official Title		Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma Low Grade
Trial Start Date		1996-03-06
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00003499
Date Submitted to PDQ		1998-07-29
Information Last Verified		2009-06-07

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