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Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas Clinical research trials and Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas clinical trial. Participants frequently get the best healthcare available for their Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas  Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
For Condition: Mixed Gliomas,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 recurrent or refractorymixed gliomas.
Details: OBJECTIVES: - Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable progressive, recurrent, or persistent mixed gliomas following standard therapy. - Assess the response, 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 in the absence of toxicity and disease progression. Tumors are measured every 1-3 months for 2 years, every 3-4 months for 2 years, every 4-6 months for 1 year, then annually thereafter. PROJECTED ACCRUAL: This study will accrue 20-40 patients.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed incurable primary mixed glioma that is progressive, persistent, or recurrent following initial standard therapy, including radiation therapy - Measurable disease by CT scan or MRI - 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 2000/mm3 - Platelet count at least 50,000/mm3 Hepatic: - No hepatic insufficiency - Bilirubin no greater than 2.5 mg/mL - SGOT and SGPT no greater than 5 times upper limit of normal Renal: - No renal insufficiency - Creatinine no greater than 2.5 mg/mL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No known chronic heart failure - No uncontrolled hypertension - No history of congestive heart failure - No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No severe lung disease - No severe chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study - No other severe medical illness - No nonmalignant systemic disease - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy (unless there is evidence of disease progression) Surgery: - Fully recovered 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: CDR0000066510; BC-BT-18
Study Start Date:
Record last reviewed: October 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003473
Other Recurrent Adult Brain Tumor Studies:
1. Fenretinide in Treating Patients With Recurrent Malignant Glioma
2. Phase II Study of Carmustine, Streptozocin, and Mercaptopurine for Refractory or Recurrent Brain Neoplasms
3. Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
4. Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
5. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Mixed Gliomas
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