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Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma



Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma

For Condition: recurrent childhood cerebral astrocytoma,low-grade childhood cerebral astrocytoma
Status: Recruiting
Sponsor(s): Burzynski Research Institute ,
Synopsis: 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 studies the effectiveness of antineoplaston therapy in treating children who have low-gradeastrocytoma.
Details: OBJECTIVES: - Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with low-grade astrocytoma by determining the proportion of patients who experience an objective tumor response. - Evaluate the adverse effects of and tolerance to this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. After 2 months, patients with responding or stable disease may continue treatment. Tumors are measured every 8 weeks for 2 years, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /17 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed low-grade astrocytoma 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 PATIENT CHARACTERISTICS: Age: - 6 months to 17 years Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count greater than 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 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 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 for cerebral edema allowed (must be on stable dose for at least 1 week prior to study entry) Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No prior antineoplaston therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StanislawBurzynski,  Study Chair,  Burzynski Research Institute

Burzynski Clinic *Recruiting*
Houston,  Texas,  77055-6330
United States
Recruiting Stanislaw  Burzynski 713-335-5697


Additional Information:
Study ID Numbers:  CDR0000066504;  BC-BT-13
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003468

Other Recurrent Childhood Cerebral Astrocytoma Studies:
1. Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma

2. Docetaxel in Treating Children With Recurrent Solid Tumors

3. Carmustine Implants and O(6)-Benzylguanine in Treating Children With Recurrent Malignant Glioma

4. Vinorelbine in Treating Children With Recurrent or Refractory Cancers

5. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma

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Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma
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