View Clinical Trial (Medical Research Study)
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Anaplastic Astrocytoma
| 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 anaplastic astrocytoma that has not responded to previous treatment.
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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 incurable anaplastic astrocytoma who experienced disease progression or
recurrence or have residual disease after standard therapy.
- Describe response, 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 3 months in the absence of toxicity and disease
progression. Patients achieving complete response (CR) continue treatment for an additional
8 months after reaching CR.
Tumors are measured every 2 months during the first year, every 3 months for the second
year, every 3-4 months during the third and fourth years, every 4-6 months during the fifth
year, and yearly 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 anaplastic astrocytoma that has progressed,
recurred, or persisted after completion of standard therapy (including radiation
therapy)
- Measurable disease by MRI or CT scan
- Tumor must be at least 5 mm
- Must have received prior standard therapy (i.e., radiation therapy, chemotherapy,
immunotherapy, or cytodifferentiating agent)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 2 months
Hematopoietic:
- WBC at least 2000/mm^3
- Platelet count at least 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 uncontrolled hypertension
- No history of congestive heart failure
- No history of 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
- No active infection
- 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:
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy and recovered
Surgery:
- Fully recovered from any prior surgery
Other:
- Prior cytodifferentiating agent allowed
- No prior antineoplaston therapy
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| NCT ID: |
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NCT00003470 |
| 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 17, 2013 |
| Modifications to this listing: |
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