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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma  Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
For Condition: adult anaplastic astrocytoma,recurrent adult 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 patients who have anaplasticastrocytoma that has not responded to previous treatment.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable anaplastic astrocytoma who experienced disease progression or recurrence or have residual disease after standard therapy. - Describe response, tolerance to, and side effects of this regimen in these patients. OUTLINE: 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 toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 1-3 months during the first 2 years, every 3-4 months during the third year, every 4-6 months during the fourth and fifth years, and yearly 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 incurable anaplastic astrocytoma that has progressed, recurred, or persisted after completion of standard therapy (including radiation therapy) - Measurable disease by MRI or CT scan - Tumor must be at least 5 mm - Must have received prior standard therapy (i.e., radiation therapy, chemotherapy, immunotherapy, or cytodifferentiating agent) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2000/mm3 - Platelet count at least 50,000/mm3 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 uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease such as severe chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study - No active infection - 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 allowed Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Fully recovered from any prior surgery Other: - Prior cytodifferentiating agent allowed - 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: CDR0000066507; BC-BT-15
Study Start Date:
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003470
Other Recurrent Adult Brain Tumor Studies:
1. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
2. Immunotoxin Therapy in Treating Patients With Malignant Glioma
3. Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
4. Temozolomide in Treating Patients With Recurrent Malignant Glioma
5. Karenitecin in Treating Patients With Recurrent Malignant Glioma
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
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