Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Burzynski Research Institute |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003502 |
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 stage II, stage III, or stage IV mantle cell lymphoma.
Condition | Intervention | Phase |
---|---|---|
Contiguous Stage II Mantle Cell Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Stage III Mantle Cell Lymphoma Stage IV Mantle Cell Lymphoma Recurrent Mantle Cell Lymphoma |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 Procedure: alternative product therapy Procedure: biological therapy Procedure: biologically based therapies Procedure: cancer prevention intervention Procedure: complementary and alternative therapy Procedure: differentiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage II, III, or IV Mantle Cell Lymphoma |
OBJECTIVES:
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 2 years, every 6 months for the third and fourth years, and then annually thereafter.
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: | CDR0000066542, BC-LY-9 |
Study First Received: | November 1, 1999 |
Last Updated: | December 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00003502 History of Changes |
Health Authority: | United States: Federal Government |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, Mantle-Cell Mantle Cell Lymphoma |
Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Recurrence |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |