Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus

Adenocarcinoma of the Esophagus Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003487
• Other study ID #: CDR0000066525
• Secondary ID: BC-ES-2
• Status: Terminated
• Phase: Phase 2
• Start date: May 30, 1996
• Est. completion date: April 27, 2001

Study information

• Verified date: April 2021
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current therapies for Adenocarcinoma of the Esophagus provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Adenocarcinoma of the Esophagus.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Adenocarcinoma of the Esophagus.

Description:

Esophageal cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in patients with esophageal cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).

• To determine the safety and tolerance of Antineoplaston therapy in patients with Esophageal Cancer.

• To determine objective response, tumor size is measured utilizing physical examination, and radiologic studies performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 27, 2001
• Est. primary completion date: April 27, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

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

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophagus
• Esophageal Neoplasms

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
Patients with Adenocarcinoma of the Esophagus will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable	Objective response rate per The International Working Group response criteria (1999): Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least four weeks. Stable Disease (SD), < 50% change in the sum of the products of of the greatest perpendicular diameters of all measurable lesions, sustained for at least twelve weeks.	59 months