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| ID | Type | Description | Link |
|---|---|---|---|
| UIHC-UICC-LW-02 | |||
| NCI-T99-0019 |
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Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent non-Hodgkin's lymphoma. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
OBJECTIVES:
I. Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10.
II. Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients.
III. Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and determine the optimal biological dose of this drug in these patients.
IV. Evaluate any antilymphoma effects of this drug in these patients.
OUTLINE: This is a dose escalation, multicenter study.
Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.
Patients are followed at 4 weeks, 50 days, and periodically thereafter until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apolizumab | Biological |
|
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Link, MD | Holden Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States | ||
| University of Iowa Hospitals and Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Link BK, Wang H, Byrd JC, et al.: Phase I trial of humanized 1D10 (Hu1D10) monoclonal anitbody class II molecules in patients with relapsed lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A86, 2000. |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002051 | Burkitt Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C448699 | apolizumab |
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| Iowa City |
| Iowa |
| 52242 |
| United States |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21231 | United States |
| Biologics Evaluation Section | Bethesda | Maryland | 20892-9903 | United States |
| New York Presbyterian Hospital - Cornell Campus | New York | New York | 10021 | United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |