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Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma Clinical research trials and Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma healthcare trials occur in a lot of 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 generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma  Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
For Condition: adult immunoblastic large cell lymphoma,adult Burkitt's lymphoma,adult lymphoblastic lymphoma
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 refractoryhigh-gradestage II, stage III, or stage IV non-Hodgkin's lymphoma after receiving chemotherapy.
Details: OBJECTIVES: - Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening recurrent or refractory high-grade non-Hodgkin's lymphoma. - Describe response to, 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 for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment. Tumors are measured at least every 8 weeks for 6 months, every 3 months for 1.5 years, every 6 months for 2 years, and then annually for 2 years. Patients are followed for survival. 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 proven stage II, III, or IV high-grade non-Hodgkin's lymphoma that has not responded to, or has relapsed after a standard primary chemotherapy regimen plus at least 1 standard second-line salvage chemotherapy regimen NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adoptedby PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC greater than 2000/mm^3 - Platelet count greater than 50,000/mm^3 Hepatic: - Bilirubin no greater than 2.5 mg/dL 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 cardiovascular conditions that contraindicate high dosages of sodium Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No active infection requiring treatment PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulatory agent (e.g., interferon or interleukin-2) Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agent Endocrine therapy: - At least 4 weeks since prior dexamethasone, prednisone, or other corticosteroids - No concurrent corticosteroid Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No prior antineoplaston therapy - No concurrent antibiotics, antifungals, or antivirals
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: CDR0000066541; BC-LY-8
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003501
Other Adult Lymphoblastic Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
2. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma
3. Chemoradiotherapy and Peripheral Stem Cell Transplantation Compared With Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma
4. Combination Chemotherapy and Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
5. Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
Related Studies:
Other adult lymphoblastic lymphoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma
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