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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors  Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
For Condition: 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 primarymalignant brain tumors.
Details: OBJECTIVES: - Provide antineoplastons A10 and AS2-1 as treatment for patients with incurable primary malignant brain tumor that has progressed during or is recurrent or persistent after prior standard therapy, including radiotherapy and/or chemotherapy. - Describe the response to, tolerance to, and side effects of this regimen in these patients. OUTLINE: Patients receive gradually escalating doses of intravenous antineoplastons A10 and AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Patients are followed at least every 2 months for 1 year, every 3 months for 1 year, every 3-4 months for 2 years, every 4-6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: Approximately 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 incurable primary malignant brain tumor that has progressed during or is recurrent after prior initial therapy, including radiotherapy - Failed prior standard therapy - Measurable disease by MRI or CT scan - No brain stem tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - Hematological function normal - WBC at least 2000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - No liver failure - No evidence of hepatic insufficiency - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit of normal Renal: - No evidence of renal insufficiency - 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 chronic heart failure - No 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 participation - No medical or psychiatric illness that would preclude study treatment - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No concurrent immunomodulating agents Chemotherapy: - At least 4 weeks since prior chemotherapy, except in patients with disease progression during initial therapy - At least 6 weeks since prior nitrosoureas, except in patients with disease progression during initial therapy - No concurrent antineoplastic agents Endocrine therapy: - Corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior radiotherapy, except in patients with disease progression during initial therapy Surgery: - At least 4 weeks since prior surgery, except in patients with disease progression during initial therapy Other: - Recovered from prior therapy - Cytodifferentiating agents allowed
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: CDR0000066512; BC-BT-21
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003475
Other Adult Brain Tumor Studies:
1. Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors
2. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors
3. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
4. Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
5. Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
Related Studies:
Other adult brain tumor Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors
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