Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus

• Sponsor: Burzynski Research Institute (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00003487
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 58.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Esophagus	Drug: Antineoplaston therapy (Atengenal + Astugenal)	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Adenocarcinoma of the Esophagus
• Actual Study Start Date: May 30, 1996
• Actual Primary Completion Date: Apr 27, 2001
• Actual Study Completion Date: Apr 27, 2001

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Antineoplaston therapy Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

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.; Other Names: A10 (Atengenal); AS2-1 (Astugenal)

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable [59 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burzynski Clinic	Houston	Texas	United States	77055-6330

Sponsors and Collaborators

• Burzynski Research Institute

Investigators

• Principal Investigator: Stanislaw R Burzynski, MD, PhD, Burzynski Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Burzynski Research Institute
• ClinicalTrials.gov Identifier: NCT00003487
• Other Study ID Numbers: CDR0000066525; BC-ES-2
• First Posted: Jan 27, 2003
• Last Update Posted: May 14, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Burzynski Research Institute: esophageal cancer; recurrent esophageal cancer; stage IV esophageal cancer
• Additional relevant MeSH terms: Adenocarcinoma; Esophageal Neoplasms

Study Results

Participant Flow

Arm/Group Title	Antineoplaston Therapy
Arm/Group Description	Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. 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.
Period Title: Overall Study
STARTED	8
COMPLETED	6
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Antineoplaston Therapy
Arm/Group Description	Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. 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.
Overall Participants	8
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	52.2
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	8 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable
Description	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.
Time Frame	59 months

Outcome Measure Data

Analysis Population Description

All patients enrolled in the study.

Arm/Group Title	Antineoplaston Therapy
Arm/Group Description	Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. 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.
Measure Participants	8
Number [participants]	8 100%

Adverse Events

Time Frame	4 years, 11 months
Arm/Group Title	Antineoplaston Therapy
Arm/Group Description	Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. 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.
All Cause Mortality
	Antineoplaston Therapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Antineoplaston Therapy
	Affected / at Risk (%)	# Events
Total	5/8 (62.5%)
Blood and lymphatic system disorders
Hemoglobin	1/8 (12.5%)
Cardiac disorders
Hypotension	1/8 (12.5%)
Gastrointestinal disorders
Hemorrhage: Gastrointestinal	4/8 (50%)
General disorders
Fatigue	1/8 (12.5%)
Fever	1/8 (12.5%)
Respiratory, thoracic and mediastinal disorders
Infection: Pneumonia	1/8 (12.5%)
Other (Not Including Serious) Adverse Events
	Antineoplaston Therapy
	Affected / at Risk (%)	# Events
Total	8/8 (100%)
Blood and lymphatic system disorders
Hemoglobin	6/8 (75%)
Leukocytes (total WBC)	1/8 (12.5%)
Neutrophils/granulocytes (ANC/AGC)	1/8 (12.5%)
Cardiac disorders
Supraventricular and nodal arrhythmia	2/8 (25%)
Hypertension	1/8 (12.5%)
Hypotension	1/8 (12.5%)
Ear and labyrinth disorders
Hearing (without monitoring program)	1/8 (12.5%)
Tinnitus	1/8 (12.5%)
Gastrointestinal disorders
Constipation	2/8 (25%)
Diarrhea	3/8 (37.5%)
Nausea	7/8 (87.5%)
Vomiting	4/8 (50%)
Hemorrhage, GI	5/8 (62.5%)
General disorders
Allergic reaction/hypersensitivity (including drug fever)	1/8 (12.5%)
Non-functional Central Venous Catheter	4/8 (50%)
Fatigue (asthenia, lethargy, malaise)	4/8 (50%)
Fever	4/8 (50%)
Rigors/chills	1/8 (12.5%)
Edema/Fluid retention	4/8 (50%)
Pain: Pain NOS	1/8 (12.5%)
Infections and infestations
Infection (documented clinically): Abdomen NOS	1/8 (12.5%)
Infection (documented clinically): Blood	1/8 (12.5%)
Infection (documented clinically): Lung (pneumonia)	2/8 (25%)
Infection (documented clinically): Small bowel NOS	1/8 (12.5%)
Infection (documented clinically): Upper airway NOS	3/8 (37.5%)
Opportunistic infection	4/8 (50%)
Flu-like illness	1/8 (12.5%)
Investigations
Albumin, serum-low (hypoalbuminemia)	3/8 (37.5%)
Alkaline phosphatase	3/8 (37.5%)
Hyperbilirubinemia	1/8 (12.5%)
Hyperglycemia	5/8 (62.5%)
Hyperkalemia	1/8 (12.5%)
Hypernatremia	4/8 (50%)
Hypocalcemia	5/8 (62.5%)
Hypoglycemia	2/8 (25%)
Hypokalemia	6/8 (75%)
Hypomagnesemia	1/8 (12.5%)
Metabolic/Laboratory - Other	1/8 (12.5%)
SGOT	2/8 (25%)
SGPT	2/8 (25%)
Uric acid, serum-high (hyperuricemia)	2/8 (25%)
Musculoskeletal and connective tissue disorders
Pain: Back	2/8 (25%)
Pain: Chest wall	1/8 (12.5%)
Pain: Extremity-limb	1/8 (12.5%)
Nervous system disorders
Confusion	3/8 (37.5%)
Dizziness	2/8 (25%)
Somnolence/depressed level of consciousness	3/8 (37.5%)
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	3/8 (37.5%)
Skin and subcutaneous tissue disorders
Pruritus/itching	1/8 (12.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.