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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | August 12, 2009 | ||||
| Start Date ICMJE | March 1996 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Response rate based on tumor measurements taken at 12 weeks [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Response rate based on tumor measurements taken at 12 weeks | ||||
| Change History | Complete list of historical versions of study NCT00003499 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Survival at 1, 2, and 5 years from the start of treatment | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma | ||||
| Official Title ICMJE | Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma Low Grade | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003499 | ||||
| Responsible Party | Stanislaw R. Burzynski, Burzynski Clinic | ||||
| Study ID Numbers ICMJE | CDR0000066538, BC-LY-6 | ||||
| Study Sponsor ICMJE | Burzynski Research Institute | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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