View Clinical Trial (Medical Research Study)
Phase II Study of Antineoplastons A10 and AS2-1 in Children Wtih Brain Tumors
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77055 |
| Conditions: |
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Brain and Central Nervous System Tumors |
| Purpose: |
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RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the
laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating
children with brain tumors.
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| Study Summary: |
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OBJECTIVES:
- Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with
brain tumors by determining the proportion of patients who experience an objective
tumor response.
- Evaluate the adverse effects of and tolerance to this regimen in these children.
OUTLINE: This is an open-label study.
Patients receive gradually escalating doses of intravenous antineoplaston A10 and
antineoplaston AS2-1 6 times daily until the maximum tolerated dose is reached. Treatment
continues for at least 2 months in the absence of disease progression or unacceptable
toxicity. Patients achieving stable disease may continue treatment.
Tumors are measured every 8 weeks for 2 years, every 3 months for the third and fourth
years, every 6 months for the fifth and sixth years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed (except if medically contraindicated) severe pediatric brain
tumor that is unlikely to respond to existing therapy and for which no curative
therapy exists
- Histology requirement may be waived for brain stem tumors
- Measurable tumor by MRI or CT scan
- Tumor must be at least 5 mm
PATIENT CHARACTERISTICS:
Age:
- 6 months to 17 years
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC greater than 2000/mm^3
- Platelet count greater than 50,000/mm^3
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT and 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 history of heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of
sodium
- 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
- No concurrent immunomodulating agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- 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)
Radiation therapy:
- At least 8 weeks since prior radiotherapy and recovered
Surgery:
- Recovered from any prior surgery
Other:
- No prior antineoplaston therapy
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| NCT ID: |
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NCT00003458 |
| Primary Contact: |
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Study Chair
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Houston, Texas 77055
United States
Stanislaw R. Burzynski, MD, PhD
Phone: 713-335-5697
Email: info@burzynskiclinic.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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