NCT00003453

Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer

Terminated Phase 2 Results posted Last updated 9 May 2018

What this trial tests

Phase 2 trial testing Antineoplaston therapy (Atengenal + Astugenal) in Stage IV Adrenocortical Carcinoma in 6 participants. Terminated before completion.

Timeline

21 August 1996

Primary endpoint
5 July 2011

5 July 2011

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	6
Start date	21 August 1996
Primary completion	5 July 2011
Estimated completion	5 July 2011
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Stage IV Adrenocortical Carcinoma — all drugs for Stage IV Adrenocortical Carcinoma →

Sponsor

Burzynski Research Institute

Who can join

Adults 6 Months to 99, any sex, with Stage IV Adrenocortical 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 Primary · 12 months

Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: 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 enhancing lesions, sustained for at least four weeks.

Complete Response

Group	Value	95% CI
Antineoplaston Therapy	1

Partial Response

Group	Value	95% CI
Antineoplaston Therapy	1

Stable Disease

Group	Value	95% CI
Antineoplaston Therapy	1

Progressive Disease

Group	Value	95% CI
Antineoplaston Therapy	2

Percentage of Participants Who Survived Secondary · 6 months, 12 months, 24 months, 36 months, 48 months, 60 months

6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival

6 months overall survival

Group	Value	95% CI
Antineoplaston Therapy	83.3

12 months overall survival

Group	Value	95% CI
Antineoplaston Therapy	66.7

24 months overall survival

Group	Value	95% CI
Antineoplaston Therapy	50.0

36 months overall survival

Group	Value	95% CI
Antineoplaston Therapy	33.3

48 months overall survival

Group	Value	95% CI
Antineoplaston Therapy	33.3

60 months overaall survival

Group	Value	95% CI
Antineoplaston Therapy	33.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 13 years, 5 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Antineoplaston Therapy

Serious: 4/6 (67%)

Deaths: —

Serious adverse events (6 terms)

Reaction	System	Antineoplaston Therapy
Ascites (non-malignant)	Gastrointestinal disorders	—
Musculoskeletal/Soft Tissue - Other (Muscle Spasms)	Musculoskeletal and connective tissue disorders	—
Fever	General disorders	—
Central Venous Catheter Infection	General disorders	—
Somnolence/depressed level of consciousness	Nervous system disorders	—
Dizziness	Nervous system disorders	—

Other adverse events (76 terms — click to expand)

Reaction	System	Antineoplaston Therapy
Hypokalemia	Investigations	—
Fatigue (asthenia, lethargy, malaise)	General disorders	—
Nausea	Gastrointestinal disorders	—
Hemoglobin	Blood and lymphatic system disorders	—
Vomiting	Gastrointestinal disorders	—
Alkaline phosphatase	Investigations	—
Hypoglycemia	Investigations	—
Pain: Abdomen NOS	Gastrointestinal disorders	—
Hypertension	Cardiac disorders	—
Fever	General disorders	—
Albumin, serum-low (hypoalbuminemia)	Investigations	—
Hypernatremia	Investigations	—
Hypocalcemia	Investigations	—
SGOT	Investigations	—
Somnolence/depressed level of consciousness	Nervous system disorders	—
Pain: Head/headache	Nervous system disorders	—
Leukocytes (total WBC)	Blood and lymphatic system disorders	—
Lymphopenia	Blood and lymphatic system disorders	—
Neutrophils/granulocytes (ANC/AGC)	Blood and lymphatic system disorders	—
Platelets	Blood and lymphatic system disorders	—
Cardiac Arrhythmia - Other	Cardiac disorders	—
Central venous catheter infection	General disorders	—
Non-functional central venous catheter	General disorders	—
Central venous catheter - Other	General disorders	—
Rigors/chills	General disorders	—
Edema/Fluid retention	General disorders	—
Constipation	Gastrointestinal disorders	—
Dry mouth/salivary gland (xerostomia)	Gastrointestinal disorders	—
Hemorrhage, GU: Bladder	Renal and urinary disorders	—
Bicarbonate, serum-low	Investigations	—
Hypercholesteremia	Investigations	—
Hypertriglyceridemia	Investigations	—
Hypophosphatemia	Investigations	—
Proteinuria	Investigations	—
Uric acid, serum-high (hyperuricemia)	Investigations	—
Dizziness	Nervous system disorders	—
Pain: Muscle	Musculoskeletal and connective tissue disorders	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—
Allergic reaction/hypersensitivity (including drug fever)	Immune system disorders	—
Allergic rhinitis (including sneezing, nasal stuffiness	Immune system disorders	—

Most-reported serious reactions: Ascites (non-malignant), Musculoskeletal/Soft Tissue - Other (Muscle Spasms), Fever, Central Venous Catheter Infection, Somnolence/depressed level of consciousness, Dizziness.

Data from ClinicalTrials.gov NCT00003453 adverse events section.

Sponsor's own description

Current therapies for Stage IV adrenal gland cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV adrenal gland cancer

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV adrenal gland cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Recent Trends in Active and Passive Immunotherapies of Alzheimer's Disease.
   Alshamrani M. · · 2023 · cited 6× · PMID 37366656 · DOI 10.3390/antib12020041