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Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme



Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme

For Condition: adult glioblastoma multiforme,recurrent adult brain tumor
Status: No longer recruiting
Sponsor(s): Burzynski Research Institute ,
Synopsis: RATIONALE: Antineoplastons are naturally-occurring substances found in urine, but they may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of antineoplaston therapy in treating patients who have glioblastoma multiforme.
Details: OBJECTIVES: - Study the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable glioblastoma multiforme. - Describe response, tolerance to, and side effects of this regimen in these patients. OUTLINE: Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 six times a day until the maximum tolerated dose is reached. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Tumors are measured every 2 months during the first year and every 3 months during the second year. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued in this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy) - Measurable disease by MRI or CT scan - Brain stem tumor is excluded - Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm3 - Platelet count at least 50,000/mm3 Hepatic: - No liver failure - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit Renal: - No history of renal conditions that contraindicate high dosages of sodium - Creatinine no greater than 2.5 mg/dL Cardiovascular: - No uncontrolled hypertension - No history of congestive heart failure - No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease (e.g., severe COPD) Other: - Not pregnant or nursing - Fertile patients must use adequate contraception during and for 4 weeks after study - No active infection - No other serious medical or psychiatric conditions PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since immunotherapy - No concurrent immunomodulating agents Chemotherapy: - See Disease Characteristics - At least 4 weeks since chemotherapy (unless radiologically proven progression) - At least 6 weeks since nitrosoureas Endocrine therapy: - Corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since radiotherapy (unless radiologically proven progression) Surgery: - Recovered from prior surgery Other: - No prior antineoplaston therapy - Prior cytodifferentiating agent allowed
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StanislawBurzynski,  Study Chair,  Burzynski Research Institute

Burzynski Research Institute
Houston,  Texas,  77055-6330
United States
 


Additional Information:
Study ID Numbers:  CDR0000066511;  BRI-BT-20
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003474

Other Adult Glioblastoma Multiforme Studies:
1. Arsenic Trioxide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma

2. Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

3. Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme

4. EMD 121974 in Treating Patients With Progressive or Recurrent Glioma

5. Vaccine Therapy in Treating Patients With Malignant Glioma

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