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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma  Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
For Condition: recurrent adult brain tumor,adult juvenile pilocytic astrocytoma,Adult Subependymal Astrocytoma,adult well-differentiated mildly and moderately anaplastic 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 patients who have low-grade astrocytoma.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with low-grade astrocytoma. - Describe response to, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open-label study. 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 unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 2 months for 1 year and then every 3 months for 1 year. 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 or cytologically confirmed low-grade astrocytoma that has progressed, recurred, or persisted after initial therapy, including radiotherapy - Previously treated with at least 1 prior standard therapy (e.g., radiotherapy, chemotherapy, immunotherapy, or cytodifferentiating agent) - Must have failed standard therapy - Measurable disease by MRI or CT scan - Tumor must be at least 5 mm - No brain stem tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 2 months Hematopoietic: - WBC at least 2,000/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 renal insufficiency - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No uncontrolled hypertension - No chronic heart failure - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No severe lung disease (e.g., chronic obstructive pulmonary disease) Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No other concurrent serious disease - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulating agents Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior radiotherapy and recovered Surgery: - Must recover from prior surgery Other: - No prior antineoplastons
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: CDR0000066508; BC-BT-16
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003471
Other Adult Juvenile Pilocytic Astrocytoma Studies:
1. Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
Related Studies:
Other adult juvenile pilocytic astrocytoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Low-Grade Astrocytoma
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