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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma  Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
For Condition: noncontiguous stage 2 mantle cell lymphoma,stage 4 mantle cell lymphoma,stage 3 mantle cell lymphoma,recurrent mantle cell lymphoma,contiguous stage 2 mantle cell 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 stage II, stage III, or stage IV mantle cell lymphoma.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening stage II, III, or IV mantle cell lymphoma. - Evaluate the 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 intravenously 6 times daily until the maximum tolerated dose is reached. Treatment continues in the absence of disease progression or unacceptable toxicity. Tumors are measured every 8 weeks for 6 months, every 3 months for 1.5 years, every 6 months for 2 years, and then annually thereafter. 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 mantle cell lymphoma that is not curable by surgery, radiotherapy, and/or chemotherapy - Measurable tumor of greater than 2 cm in largest diameter for lymph nodes located in head, neck, axillary, inguinal, and femoral areas (at least 1 cm for other areas) 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: - No hepatic insufficiency - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times upper limit of normal Renal: - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No 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 serious active infections 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: - 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 corticosteroids (e.g., dexamethasone or prednisone) - No concurrent dexamethasone, prednisone, or other corticosteroids 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: CDR0000066542; BC-LY-9
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003502
Other Contiguous Stage 2 Mantle Cell Lymphoma Studies:
1. Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
2. Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
3. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
4. Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
5. Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma
Related Studies:
Other contiguous stage 2 mantle cell lymphoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Mantle Cell Lymphoma
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