View Clinical Trial (Medical Research Study)
Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant 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 primary malignant 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
primary malignant 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 12 months in the absence of disease progression or unacceptable
toxicity. After 12 months, patients with responding or 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 incurable primary malignant brain tumor that has progressed,
recurred, or persisted after initial therapy
- Must have failed prior standard therapy
- No brain stem glioma
- Evidence of tumor by MRI or CT scan
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
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| NCT ID: |
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NCT00003476 |
| 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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June 19, 2013 |
| Modifications to this listing: |
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