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| Sponsored by: |
Burzynski Research Institute |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003499 |
Purpose
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 is studying how well antineoplaston therapy works in treating patients with low-grade non-Hodgkin's lymphoma.
| 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 Low Grade |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 1996 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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 years 3 and 4, and yearly for years 5 and 6.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Texas | |
| Burzynski Clinic | Recruiting |
| Houston, Texas, United States, 77055-6330 | |
| Contact: Stanislaw R. Burzynski, MD, PhD 713-335-5697 info@burzynskiclinic.com | |
| Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
More Information
| Responsible Party: | Burzynski Clinic ( Stanislaw R. Burzynski ) |
| Study ID Numbers: | CDR0000066538, BC-LY-6 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003499 History of Changes |
| Health Authority: | Unspecified |
|
stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma contiguous stage II small lymphocytic lymphoma contiguous stage II marginal zone lymphoma |
noncontiguous stage II small lymphocytic lymphoma noncontiguous stage II marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma stage III small lymphocytic lymphoma stage III marginal zone lymphoma stage IV small lymphocytic lymphoma stage IV marginal zone lymphoma |
|
Immunoproliferative Disorders Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Follicular Lymphoma Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases |
Chronic Lymphocytic Leukemia B-cell Lymphomas Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |