NCT00003487

Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus

Terminated Phase 2 Results posted Last updated 14 May 2021

What this trial tests

Phase 2 trial testing Antineoplaston therapy (Atengenal + Astugenal) in Adenocarcinoma of the Esophagus in 8 participants. Terminated before completion.

Timeline

30 May 1996

Primary endpoint
27 April 2001

27 April 2001

Quick facts

Lead sponsor	Burzynski Research Institute
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	30 May 1996
Primary completion	27 April 2001
Estimated completion	27 April 2001
Sites	1 location across United States

Drugs / interventions tested

• Antineoplaston therapy (Atengenal + Astugenal) — full drug profile →

Conditions studied

• Adenocarcinoma of the Esophagus — all drugs for Adenocarcinoma of the Esophagus →

Sponsor

Burzynski Research Institute

Who can join

Adults 18 to 99, any sex, with Adenocarcinoma of the Esophagus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Objective Response, Stable Disease, Progressive Disease or Not Evaluable Primary · 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.

Group	Value	95% CI
Antineoplaston Therapy	8

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 years, 11 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Antineoplaston Therapy

Serious: 5/8 (63%)

Deaths: —

Serious adverse events (6 terms)

Reaction	System	Antineoplaston Therapy
Hemorrhage: Gastrointestinal	Gastrointestinal disorders	—
Hemoglobin	Blood and lymphatic system disorders	—
Hypotension	Cardiac disorders	—
Fatigue	General disorders	—
Fever	General disorders	—
Infection: Pneumonia	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (49 terms — click to expand)

Reaction	System	Antineoplaston Therapy
Nausea	Gastrointestinal disorders	—
Hemoglobin	Blood and lymphatic system disorders	—
Hypokalemia	Investigations	—
Hemorrhage, GI	Gastrointestinal disorders	—
Hyperglycemia	Investigations	—
Hypocalcemia	Investigations	—
Non-functional Central Venous Catheter	General disorders	—
Fatigue (asthenia, lethargy, malaise)	General disorders	—
Fever	General disorders	—
Edema/Fluid retention	General disorders	—
Vomiting	Gastrointestinal disorders	—
Opportunistic infection	Infections and infestations	—
Hypernatremia	Investigations	—
Diarrhea	Gastrointestinal disorders	—
Infection (documented clinically): Upper airway NOS	Infections and infestations	—
Albumin, serum-low (hypoalbuminemia)	Investigations	—
Alkaline phosphatase	Investigations	—
Confusion	Nervous system disorders	—
Somnolence/depressed level of consciousness	Nervous system disorders	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—
Supraventricular and nodal arrhythmia	Cardiac disorders	—
Constipation	Gastrointestinal disorders	—
Infection (documented clinically): Lung (pneumonia)	Infections and infestations	—
Hypoglycemia	Investigations	—
SGOT	Investigations	—
SGPT	Investigations	—
Uric acid, serum-high (hyperuricemia)	Investigations	—
Dizziness	Nervous system disorders	—
Pain: Back	Musculoskeletal and connective tissue disorders	—
Allergic reaction/hypersensitivity (including drug fever)	General disorders	—
Hearing (without monitoring program)	Ear and labyrinth disorders	—
Tinnitus	Ear and labyrinth disorders	—
Leukocytes (total WBC)	Blood and lymphatic system disorders	—
Neutrophils/granulocytes (ANC/AGC)	Blood and lymphatic system disorders	—
Hypertension	Cardiac disorders	—
Hypotension	Cardiac disorders	—
Rigors/chills	General disorders	—
Pruritus/itching	Skin and subcutaneous tissue disorders	—
Infection (documented clinically): Abdomen NOS	Infections and infestations	—
Infection (documented clinically): Blood	Infections and infestations	—

Most-reported serious reactions: Hemorrhage: Gastrointestinal, Hemoglobin, Hypotension, Fatigue, Fever, Infection: Pneumonia.

Data from ClinicalTrials.gov NCT00003487 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.