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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma  Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
For Condition: grade 1 follicular lymphoma,grade 2 follicular lymphoma,adult non-Hodgkin's 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 low-gradenon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening low grade non-Hodgkin's lymphoma. - Describe 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 intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression and unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment. Tumors are measured every 8 weeks for the first 6 months, every 3 months for the first 2 years, every 6 months for the next 2 years, and yearly for the next 2 years. 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 low grade non-Hodgkin's lymphoma that is unlikely to respond to existing therapy or for which no established therapy exists NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by 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/mm3 - Platelet count greater than 50,000/mm3 Hepatic: - Bilirubin normal Renal: - Creatinine normal - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No hypertension - No history of congestive heart failure - No history of other 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 - No serious active infections PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since immunotherapy and recovered - No concurrent immunomodulating agents (e.g., interferon, interleukin-2) Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: - At least 4 weeks since prior corticosteroids - No concurrent corticosteroids Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Not specified Other: - No prior antineoplaston therapy - No other concurrent antineoplastic agents - 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: CDR0000066538; BC-LY-6
Study Start Date:
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003499
Other Grade 1 Follicular Lymphoma Studies:
1. Tipifarnib in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. Combination Chemotherapy and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
3. Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma, Hodgkin's Lymphoma, or Non-Hodgkin's Lymphoma
4. Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction
5. VEGF Trap in Treating Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkin's Lymphoma
Related Studies:
Other grade 1 follicular lymphoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
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