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Antineoplaston Therapy in Treating Patients With Brain Tumors



Antineoplaston Therapy in Treating Patients With Brain Tumors

For Condition: ACTH-producing pituitary tumor,TSH producing pituitary tumor,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 brain tumors.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening brain tumors. - Describe response to, 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 2 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. Patients achieving partial response or stable disease continue treatment until disease progression. Tumors are measured every 1-3 months for 2 years, every 3-4 months for 1 year, every 4-6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Not specified
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed (except brain stem locations) brain tumor that is unlikely to respond to existing therapy and for which no curative therapy exists - Evidence of tumor by gadolinium-enhanced MRI, CT scan, or positron emission tomography - Tumor must be at least 5 mm - Ineligible for other BRI brain tumor protocols PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - Hemoglobin at least 9 g/dL - 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/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 uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium 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) - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids for cerebral edema allowed (must be on a stable dose for at least 1 week prior to study entry) Radiotherapy: - At least 8 weeks since prior radiotherapy Surgery: - Must recover from 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:
  CDR0000066489;  BC-BT-9
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003457

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3. Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Malignant Glioma

4. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer

5. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer

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