NCT00003526

Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin

Terminated Phase 2 Results posted Last updated 17 December 2020

What this trial tests

Phase 2 trial testing Antineoplaston therapy (Atengenal + Astugenal) in Unknown Primary Carcinoma in 8 participants. Terminated before completion.

Timeline

18 March 1996

Primary endpoint
2 February 2005

2 February 2005

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	18 March 1996
Primary completion	2 February 2005
Estimated completion	2 February 2005
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Unknown Primary Carcinoma — all drugs for Unknown Primary Carcinoma →

Sponsor

Burzynski Research Institute

Who can join

Adults 6 Months to 99, any sex, with Unknown Primary Carcinoma. 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 or Stable Disease Primary · 5 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.

Stable Disease

Group	Value	95% CI
Antineoplaston Therapy	1

Progressive Disease

Group	Value	95% CI
Antineoplaston Therapy	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 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: 2/8 (25%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Antineoplaston Therapy
Hemorrhage, GI: Abdomen NOS	Gastrointestinal disorders	—
Infection (documented clinically): Lung (pneumonia)	Infections and infestations	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (42 terms — click to expand)

Reaction	System	Antineoplaston Therapy
Hypokalemia	Investigations	—
Hypernatremia	Investigations	—
Fatigue (asthenia, lethargy, malaise)	General disorders	—
Edema/Fluid retention	Skin and subcutaneous tissue disorders	—
Hyperglycemia	Investigations	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—
Hemoglobin	Blood and lymphatic system disorders	—
Fever	General disorders	—
Diarrhea	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Hemorrhage, GI	Gastrointestinal disorders	—
Lung (pneumonia)	Infections and infestations	—
SGOT	Investigations	—
Dizziness	Nervous system disorders	—
Somnolence/depressed level of consciousness	Nervous system disorders	—
Pain: Head/headache	General disorders	—
Allergic reaction/hypersensitivity (including drug fever)	General disorders	—
Tinnitus	Ear and labyrinth disorders	—
Lymphopenia	Blood and lymphatic system disorders	—
Non-functional Central Venous Catheter	General disorders	—
Dysphagia (difficulty swallowing)	Gastrointestinal disorders	—
Infection (documented clinically): Bladder (urinary)	Infections and infestations	—
Infection (documented clinically): Upper airway NOS	Infections and infestations	—
Infection: Other	Infections and infestations	—
Albumin, serum-low (hypoalbuminemia)	Investigations	—
Alkaline phosphatase	Investigations	—
Hyperbilirubinemia	Investigations	—
Hypocalcemia	Investigations	—
Hypochloremia	Investigations	—
Hypoglycemia	Investigations	—
Hyponatremia	Infections and infestations	—
Metabolic/Laboratory - Other	Investigations	—
SGPT	Investigations	—
Confusion	Nervous system disorders	—
Mood alteration	Nervous system disorders	—
Neuropathy: cranial: CN VII Motor-face; Sensory-taste	Nervous system disorders	—
Seizure	Nervous system disorders	—
Speech impairment	Nervous system disorders	—
Pain: Joint	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Hemorrhage, GI: Abdomen NOS, Infection (documented clinically): Lung (pneumonia), Dyspnea (shortness of breath).

Data from ClinicalTrials.gov NCT00003526 adverse events section.

Sponsor's own description

Current therapies for Cancer of Unknown Primary Origin provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Cancer of Unknown Primary Origin.

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.