A Phase 2 interventional study of Antineoplaston therapy (Atengenal + Astugenal) in Refractory Brain Tumors, sponsored by Burzynski Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-08-22.
Sponsored by Burzynski Research Institute · Phase 2, Interventional, and Treatment
RATIONALE: Current therapies for adults with persistent or recurrent brain tumors provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with persistent or recurrent brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with persistent or recurrent brain tumors.
OBJECTIVES:
OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent brain tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.
To determine objective response, tumor size is measured utilizing MRI scans, which are 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.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 40 is close to the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Burzynski Research Institute is the lead sponsor of 65 studies on the registry; 2 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 12 (35%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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)
Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
Also known as: A10 (Atengenal); AS2-1 (Astugenal)
Number of Participants With Objective Response
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; Stable Disease (SD), \< 50% decrease and \< 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.
Time frame: 12 months
Percentage of Participants Who Survived
6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
Time frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Fourty patients were recruited between July 1996 and March 2011. All study subjects were seen at the Burzynski Clinic in Houston TX
| Milestone | Antineoplaston Therapy |
|---|---|
| Started | 40 |
| Completed | 31 |
| Not completed | 9 |
| Withdrew: Not evaluable | 9 |
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; Stable Disease (SD), \< 50% decrease and \< 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), \>=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.
| Participants | Antineoplaston Therapy |
|---|---|
| Complete Response | 4 |
| Partial Response | 5 |
| Stable Disease | 12 |
| Progressive Disease | 10 |
6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
| Percentage of participants | Antineoplaston Therapy |
|---|---|
| 6 months overall survival | 70.0 |
| 12 months overall survival | 50.0 |
| 24 months overall survival | 40.0 |
| 36 months overall survival | 35.0 |
| 48 months overall survival | 30.0 |
| 60 months overall survival | 22.5 |
Collected over 15 years, 7 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antineoplaston Therapy | — | 27/40 (67.5%) | 40/40 (100%) |
| Event | Antineoplaston Therapy |
|---|---|
| SeizureNervous system disorders | 11/40 |
| Central venous catheter infectionGeneral disorders | 5/40 |
| Infection (documented clinically): BloodInfections and infestations | 5/40 |
| Infection (documented clinically): Lung (pneumonia)Infections and infestations | 3/40 |
| Somnolence/depressed level of consciousnessNervous system disorders | 3/40 |
| Thrombosis/thrombus/embolismVascular disorders | 3/40 |
| Fatigue (asthenia, lethargy, malaise) Fatigue (asthenia, lethargy, malaise)General disorders | 2/40 |
| Hemorrhage, CNSNervous system disorders | 2/40 |
| Infection (documented clinically): Skin (cellulitis)Infections and infestations | 2/40 |
| HypernatremiaInvestigations | 2/40 |
| Event | Antineoplaston Therapy |
|---|---|
| HypokalemiaInvestigations | 37/40 |
| Fatigue (asthenia, lethargy, malaise)General disorders | 28/40 |
| HypernatremiaInvestigations | 26/40 |
| HyperglycemiaInvestigations | 19/40 |
| HypocalcemiaInvestigations | 19/40 |
| NauseaGastrointestinal disorders | 18/40 |
| Pain: Head/headacheNervous system disorders | 18/40 |
| VomitingGastrointestinal disorders | 16/40 |
| Somnolence/depressed level of consciousnessNervous system disorders | 16/40 |
| Edema/Fluid retentionGeneral disorders | 15/40 |
| Age, Continuous(Years) | Antineoplaston Therapy |
|---|---|
| Median | 36.0 (18.1 to 64.2) |
| Sex: Female, Male(Participants) | Antineoplaston Therapy |
|---|---|
| Female | 18 |
| Male | 22 |
Plan to share: No
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Burzynski Research Institute