- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003476
Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant Brain Tumors
RATIONALE: Current therapies for children with primary malignant brain tumors provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with primary malignant brain tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with primary malignant brain tumors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in children with primary malignant brain tumors 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 children with primary malignant brain tumors.
OVERVIEW: This is a single arm, open-label study in which children with primary malignant 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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77055-6330
- Burzynski Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed incurable primary malignant brain tumor that has progressed, recurred, or persisted after initial therapy (must have failed standard therapy).
- Evidence of residual tumor by MRI performed within two weeks prior to study entry
PATIENT CHARACTERISTICS:
Age:
- 6 months to 17 years
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 1,500/mm^3
- Platelet count greater than 50,000/mm^3
Hepatic:
- No hepatic failure
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
Renal:
- Creatinine no greater than 2.5 mg/dL
Cardiovascular:
- No severe heart disease
- No uncontrolled hypertension
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 concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulating agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No concurrent antineoplastic agents
Endocrine therapy:
- Recovered from prior endocrine therapy
- Concurrent corticosteroids for cerebral edema allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy (unless clear radiological evidence of progression) and recovered
Surgery:
- At least 4 weeks since prior surgery (unless clear radiological evidence of progression) and recovered
Other:
- No prior antineoplaston therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Antineoplaston therapy
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.
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Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Objective Response
Time Frame: 12 months
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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 eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Survived
Time Frame: 6 months, 12 months
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Six months and Twelve months overall survival
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6 months, 12 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A, Brookman, S. A phase II study of Antineoplastons A10 and AS2-1 in children with recurrent, refractory or progressive primary brain tumors - Final Report (Protocol BT-22). Journal of Cancer Therapy, 5:977-988, 2014.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent childhood anaplastic astrocytoma
- childhood brainstem glioma
- childhood anaplastic astrocytoma
- childhood glioblastoma multiforme
- recurrent childhood glioblastoma multiforme
- recurrent childhood brainstem glioma
- childhood primitive neuroectodermal tumor
- recurrent childhood primitive neuroectodermal tumor
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066513
- BC-BT-22 (Other Identifier: Burzynski Research Institute, Inc.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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