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| Sponsor: | City of Hope Medical Center |
|---|---|
| Information provided by (Responsible Party): | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00720135 |
Purpose
RATIONALE: Biological therapies, such as fusion protein cytokine therapy, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fusion protein cytokine therapy together with rituximab may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of fusion protein cytokine therapy when given after rituximab in treating patients with B-cell non-Hodgkin lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Anaplastic Large Cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Marginal Zone Lymphoma Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Testicular Lymphoma Waldenstrom Macroglobulinemia |
Biological: DI-Leu16-IL2 immunocytokine Biological: rituximab Other: flow cytometry Other: immunohistochemistry staining method Other: pharmacological study Other: laboratory biomarker analysis Other: enzyme-linked immunosorbent assay Genetic: reverse transcriptase-polymerase chain reaction |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of De-Immunized DI-Leu16-IL2 Immunocytokine in Patients With B-Cell Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 36 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive DI-Leu16-IL2 immunocytokine IV over 4 hours once weekly on days 2, 9, 16, and 23. Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
|
Biological: DI-Leu16-IL2 immunocytokine
Given IV
Other Names:
Biological: rituximab
Given IV
Other Names:
Other: flow cytometry
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Name: ELISA
Genetic: reverse transcriptase-polymerase chain reaction
Correlative studies
Other Name: RT-PCR
|
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of DI-Leu16-IL2 following peripheral blood B cell depletion with rituximab in patients with B-cell NHL.
II. To investigate the optimal biological dose (OBD) of DI-Leu16-IL2 following peripheral blood B cell depletion with rituximab in patients with B-cell NHL, which may differ from the MTD.
III. To describe the toxicities associated with the proposed DI-Leu16-IL2 regimen.
SECONDARY OBJECTIVES:
I. To evaluate the immunogenicity as measured by the induction of DI-Leu16-IL2-specific antibodies.
II. To evaluate the pharmacokinetics of DI-Leu16-IL2. III. To document any clinical responses associated with the proposed therapy and survival endpoints of the enrolled patients.
OUTLINE: This is a dose-escalation study of DI-Leu16-IL2 immunocytokine.
Patients receive DI-Leu16-IL2 immunocytokine IV over 4 hours once weekly on days 2, 9, 16, and 23.
Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on days 1, 8, 15, and 22.
Treatment repeats every 6 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion
Exclusion
Contacts and Locations| United States, California | |
| City of Hope | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Ryotaro Nakamura 800-826-4673 rnakamura@coh.org | |
| Principal Investigator: Ryotaro Nakamura | |
| Principal Investigator: | Ryotaro Nakamura | Beckman Research Institute |
More Information
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00720135 History of Changes |
| Other Study ID Numbers: | 03131, NCI-2010-01228, CDR0000598679 |
| Study First Received: | July 19, 2008 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Lymphoma Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphomatoid Granulomatosis Waldenstrom Macroglobulinemia Lymphoma, B-Cell Lymphoma, Large-Cell, Anaplastic Lymphoma, B-Cell, Marginal Zone Lymphoma, Extranodal NK-T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Precancerous Conditions Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoma, T-Cell Antibodies Antibodies, Monoclonal Rituximab Interleukin-2 |