- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003475
Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Primary Malignant Brain Tumors
RATIONALE: Current therapies for adults with primary malignant brain tumors that have not responded to standard therapy 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 primary malignant brain tumors that have not responded to standard therapy.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with primary malignant brain tumors that have not responded to standard therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with primary malignant brain tumors that have not responded to standard therapy, 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 primary malignant brain tumor.
OVERVIEW: This is a single arm, open-label study in which adults with malignant brain tumors that have not responded to standard therapy 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 or cytologically confirmed incurable adult primary malignant brain tumor
- Evidence of progressive or recurrent tumor by MRI scan performed within 2 weeks prior to study entry
- Must have received and failed standard therapy
- Tumor must be at least 5 mm
- No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- Hematological function normal
- WBC at least 2000/mm^3
- Platelet count at least 50,000/mm^3
Hepatic:
- No liver failure
- No evidence of hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
Renal:
- No evidence of renal insufficiency
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No uncontrolled hypertension
- No history of congestive heart failure
- No chronic heart failure
- No other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No serious lung disease, such as severe chronic obstructive pulmonary disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No medical or psychiatric illness that would preclude study treatment
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No concurrent immunomodulating agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy, except in patients with disease progression during initial therapy
- At least 6 weeks since prior nitrosoureas, except in patients with disease progression during initial therapy
- No concurrent antineoplastic agents
Endocrine therapy:
- Corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 8 weeks since prior radiotherapy, except in patients with disease progression during initial therapy
Surgery:
- At least 4 weeks since prior surgery, except in patients with disease progression during initial therapy
Other:
- Recovered from prior therapy
- Cytodifferentiating agents allowed
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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Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
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.
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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, 24 months, 36 months, 48 months, 60 months
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6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
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6 months, 12 months, 24 months, 36 months, 48 months, 60 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Burzynski SR, Janicki TJ, Burzynski GS. A phase II study of antineoplastons A10 and AS2-1 in adult patients with recurrent glioblastoma multiforme: Final report (protocol BT-21). Journal of Cancer Therapy 5:946-956, 2014. DOI: http://dx.doi.org/10.4236/jct.2014.510100
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066512
- BC-BT-21 (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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