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 Cancer of the Esophagus

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Other BC-ES-2 NCT00003487

Objectives

1. Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable adenocarcinoma of the esophagus.
2. Describe the response to, tolerance to, and side effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the esophagus that is unlikely to respond to existing therapy and for which no curative therapy exists



• Meets 1 of the following criteria:
  • Metastatic disease
  • Not curable with surgery or radiotherapy



• Measurable disease by MRI or CT scan

Prior/Concurrent Therapy:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

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

Endocrine therapy:

• Concurrent steroids allowed

Radiotherapy:

• At least 8 weeks since prior radiotherapy (except in patients with multiple tumors who have received radiotherapy to some of their tumors) and recovered

Surgery:

• Recovered from prior surgery

Other:

• No prior antineoplaston therapy
• Prior cytodifferentiating agents allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2000/mm3
• Platelet count at least 50,000/mm3

Hepatic:

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

Renal:

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

Cardiovascular:

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

Pulmonary:

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

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No medical illness, psychiatric illness, or non-malignant systemic disease that would preclude study treatment
• No active infection

Expected Enrollment

Approximately 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 antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) continue treatment for at least 8 months beyond CR. Patients achieving a partial response or stable disease continue treatment until disease progression.

Tumors are measured every 2 months for 1 year and then every 3 months for the second year.

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 Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus
Trial Start Date		1996-05-30
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00003487
Date Submitted to PDQ		1998-07-29
Information Last Verified		2008-04-06

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