View Clinical Trial (Medical Research Study)
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With 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
patients with brain tumors.
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| Study Summary: |
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OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in
patients with serious or immediately life-threatening brain tumors.
- Describe response to, tolerance to, and side effects of this regimen in these patients.
OUTLINE: Patients receive gradually escalating doses of antineoplaston A10 and
antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose
is reached.
Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR. Patients achieving partial response or stable disease continue
treatment until disease progression.
Tumors are measured every 1-3 months for 2 years, every 3-4 months for the third and fourth
years, every 4-6 months for the fifth year, and then annually thereafter.
PROJECTED ACCRUAL: Not specified
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed (except brain stem locations) brain tumor that is unlikely
to respond to existing therapy and for which no curative therapy exists
- Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron emission
tomography
- Tumor must be at least 5 mm
- Ineligible for other BRI brain tumor protocols
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- Hemoglobin at least 9 g/dL
- WBC at least 2,000/mm^3
- Platelet count at least 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 history of 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 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)
- No concurrent antineoplastic agents
Endocrine therapy:
- Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for
at least 1 week prior to study entry)
Radiotherapy:
- At least 8 weeks since prior radiotherapy
Surgery:
- Must recover from prior surgery
Other:
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy
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| NCT ID: |
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NCT00003457 |
| 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 20, 2013 |
| Modifications to this listing: |
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