Antineoplaston Therapy in Treating Patients With Brain Stem Glioma

Brain Stem Gliomas Clinical Trial

Official title:

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Stem Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003459
• Other study ID #: CDR0000066491
• Secondary ID: BC-BT-11
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 11, 2018
• Start date: March 1996
• Est. completion date: September 2007

Study information

• Verified date: March 2018
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain stem gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) and adults with newly-diagnosed or recurrent brain stem gliomas.

Description:

OBJECTIVES:

• To determine the efficacy of Antineoplaston therapy in patients with a brain stem glioma, 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 a brain stem glioma.

OVERVIEW: This is a single arm, open-label study in which patients 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 in measured utilizing MRI scans, which are performed every 8 weeks for the first 2 years, every 3 months for the 3rd and 4th years, every 6 months for the 5th and 6th years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 99 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed (except if medically contraindicated) brain stem glioma that is unlikely to respond to existing therapy and for which no curative therapy exists.

• Tumor must be at least 5 mm in maximum diameter

PATIENT CHARACTERISTICS:

Age:

• 6 months or greater

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC at least 2,000/mm^3

• Platelet count greater than 50,000/mm^3

Hepatic:

• Bilirubin no greater than 2.5 mg/dL

• SGOT/SGPT no greater than 5 times upper limit of normal

• No hepatic failure

Renal:

• Creatinine no greater than 2.5 mg/dL

• No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

• No severe heart disease

• No uncontrolled hypertension

• No history of congestive heart failure

• No other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

• No severe lung disease

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 4 weeks after study participation

• No serious active infections or fever

• No other serious concomitant disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy

• No concurrent immunomodulating agents

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• No concurrent antineoplastic agents

Endocrine therapy:

• Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week before study entry)

Radiotherapy:

• At least 8 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• No prior Antineoplaston therapy

Related Conditions & MeSH terms

• Brain Stem Gliomas
• Glioma

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A. The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma. Childs Nerv Syst. 2014 Dec;30(12):2051-61. doi: 10.1007/s00381-014-2401-z. Epub 2014 Apr 10. — View Citation

Burzynski, S.R., Janicki, J., Burzynski, G., Marszalek, A. A Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Brainstem Gliomas. The Report on Non-Diffuse Intrinsic Pontine Glioma (Protocol BT-11). Journal of Cancer Therapy, 6: 334-344, 2015

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Percentage of Participants Who Survived	6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival	6 months, 12 months, 24 months, 36 months, 48 months, 60 months

External Links

•   Burzynski Clinic
•   Burzynski Research Institute