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Tracking Information | |
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First Received Date † | August 15, 2001 |
Last Updated Date | June 23, 2005 |
Start Date † | May 1999 |
Current Primary Outcome Measures † | |
Original Primary Outcome Measures † | |
Change History | Complete list of historical versions of study NCT00022906 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † | |
Original Secondary Outcome Measures † | |
Descriptive Information | |
Brief Title † | Safety and Efficacy of Iodine-131 Anti-B1 Antibody for NHL Patients With Greater Than 25% Bone Marrow Involvement |
Official Title † | Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody For Patients With Previously Treated Non-Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement |
Brief Summary | The purpose of this study is to determine the proper dose, effectiveness, and safety of using Iodine-131 Anti-B1 Antibody for the treatment of patients with previously treated non-Hodgkin's lymphoma (NHL) who have greater than 25% bone marrow involvement with lymphoma. |
Detailed Description | The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti B-1 Antibody in patients with previously treated NHL having more than 25% bone marrow involvement with lymphoma. Secondary endpoints include assessment of response rate, duration of response, relapse-free survival, time to treatment failure, safety, and survival. The dose escalation will be started at 45cGy and will be escalated in 10cGy increments until the maximum tolerated dose in reached. |
Study Phase | Phase I |
Study Type † | Interventional |
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Condition † | Non-Hodgkin's Lymphoma |
Intervention † | Drug: Iodine-131 Anti-B1 Antibody |
Study Arms / Comparison Groups | |
Publications * | |
* 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 † | Active, not recruiting |
Enrollment † | 24 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00022906 |
Responsible Party | |
Secondary IDs †† | |
Study Sponsor † | Corixa Corporation |
Collaborators †† | GlaxoSmithKline |
Investigators † | |
Information Provided By | Corixa Corporation |
Verification Date | August 2004 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |