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Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma



Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma

For Condition: high-grade childhood cerebral astrocytoma,recurrent 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 recurrent or refractory high-grade glioma.
Details: OBJECTIVES: - Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with high-grade glioma 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 12 months in the absence of unacceptable toxicity or disease progression. After 12 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 incurable high-grade glioma, glioblastoma multiforme, or anaplastic astrocytoma that is refractory or recurrent, or with residual tumor after standard therapy, including radiotherapy - Evidence of tumor by gadolinium-enhanced MRI or contrast-enhanced CT scan - No brain stem tumor PATIENT CHARACTERISTICS: Age: - 6 months to 17 years Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC greater than 1,500/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 renal insufficiency Cardiovascular: - No severe heart disease - No uncontrolled hypertension - No history of congestive heart failure 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 therapy Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - 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:
  CDR0000066582;  BC-BT-6
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003535

Other High-Grade Childhood Cerebral Astrocytoma Studies:
1. TP-38 Immunotoxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma

2. Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma

3. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors

4. Vinorelbine in Treating Children With Recurrent or Refractory Cancers

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

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Antineoplaston Therapy in Treating Children With Recurrent or Refractory High-Grade Glioma

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