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Sponsored by: |
Burzynski Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003501 |
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 refractory high-grade stage II, stage III, or stage IV non-Hodgkin's lymphoma after receiving chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, High Grade |
Estimated Enrollment: | 40 |
Study Start Date: | August 1998 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Texas | |
Burzynski Clinic | |
Houston, Texas, United States, 77055-6330 |
Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Study ID Numbers: | CDR0000066541, BC-LY-8 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003501 History of Changes |
Health Authority: | United States: Federal Government |
stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma |
recurrent adult Burkitt lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult Burkitt lymphoma contiguous stage II adult lymphoblastic lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult lymphoblastic lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoblastic Lymphoma Recurrence Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Burkitt's Lymphoma |
Lymphatic Diseases Burkitt Lymphoma Lymphoma, Large-Cell, Immunoblastic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma, Large-cell Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Large-Cell, Immunoblastic Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |