Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Children With Visual Pathway Glioma
Verified date | June 2009 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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 visual pathway glioma.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 17 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed (unless medically contraindicated) visual pathway glioma that is unlikely to respond to existing therapy and for which no curative therapy exists - Evidence of tumor by MRI or CT scan - Tumor must be at least 5 mm - No brain stem tumors PATIENT CHARACTERISTICS: Age: - 6 months to 17 years Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2000/mm3 - Platelet count greater than 50,000/mm3 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 renal insufficiency - 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 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 - 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 and recovered (6 weeks for nitrosoureas) - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study) Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No prior antineoplaston therapy |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Burzynski Clinic | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Burzynski Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate based on tumor measurements taken at 12 weeks | No | ||
Secondary | Survival at 1, 2, and 5 years from the start of treatment | No |
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