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Antineoplaston Therapy in Treating Children With Brain Tumors



Antineoplaston Therapy in Treating Children With Brain Tumors

For Condition: childhood brain tumor
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 brain tumors.
Details: OBJECTIVES: - Determine the antitumor activity of antineoplastons A10 and AS2-1 in children with brain tumors by determining the proportion of patients who experience an objective tumor response. - Evaluate the adverse effects of and tolerance to this regimen in these children. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of disease progression or unacceptable toxicity. Patients achieving 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: /18 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed (except if medically contraindicated) severe pediatric brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists - Histology requirement may be waived for brain stem tumors - Measurable tumor or tumor markers by MRI or CT scan - Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: - 6 months to 18 years Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC greater than 2000/mm^3 - Platelet count greater than 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 severe heart disease - No history of heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium - No uncontrolled hypertension 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 - 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 before study entry) Radiation therapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Recovered from any prior surgery 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:  CDR0000066490;  BC-BT-10
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003458

Other Childhood Brain Tumor Studies:
1. Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma

2. Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors

3. Cilengitide in Treating Children With Refractory Primary Brain Tumors

4. Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor

5. Chemotherapy and Stem Cell Transplantation in Treating Children with Central Nervous System Cancer

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Antineoplaston Therapy in Treating Children With Brain Tumors
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