View Clinical Trial (Medical Research Study)
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients 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
patients with primary malignant brain tumors.
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| Study Summary: |
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OBJECTIVES:
- Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable primary
malignant brain tumor that has progressed during or is recurrent or persistent after
prior standard therapy, including radiotherapy and/or chemotherapy.
- Describe the response to, tolerance to, and side effects of this regimen in these
patients.
OUTLINE: Patients receive gradually escalating doses of intravenous antineoplastons A10 and
AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for
at least 3 months in the absence of disease progression or unacceptable toxicity. Patients
achieving complete response (CR) continue treatment for an additional 8 months after
reaching CR.
Patients are followed at least every 2 months for 1 year, every 3 months for the second
year, every 3-4 months for the third and fourth years, every 4-6 months for the fifth year,
and then annually thereafter.
PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed incurable primary malignant brain tumor
that has progressed during or is recurrent after prior initial therapy, including
radiotherapy
- Failed prior standard therapy
- Measurable disease by MRI or CT scan
- 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
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| NCT ID: |
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NCT00003475 |
| 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 18, 2013 |
| Modifications to this listing: |
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