Fusion Protein Cytokine Therapy After Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00720135|
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : June 8, 2015
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 or disease||Intervention/treatment||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 1|
I. To determine the maximum tolerated dose (MTD) of DI-Leu16-IL2 (DI-Leu16-IL2 immunocytokine) 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.
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 on 4 consecutive Wednesdays.
Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on 4 consecutive Tuesdays.
Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of De-Immunized DI-Leu16-IL2 Immunocytokine in Patients With B-Cell Non-Hodgkin Lymphoma|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Arm I
Patients receive DI-Leu16-IL2 immunocytokine IV over 4 hours on 4 consecutive Wednesdays. Patients with detectable CD20-positive B-cells pretreatment also receive rituximab IV on 4 consecutive Tuesdays. Treatment repeats every 6-8 weeks for up to a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Biological: DI-Leu16-IL2 immunocytokine
Other: flow cytometry
Other: immunohistochemistry staining method
Other Name: immunohistochemistry
Other: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Other: enzyme-linked immunosorbent assay
Other Name: ELISA
Genetic: reverse transcriptase-polymerase chain reaction
Other Name: RT-PCR
- Maximum tolerated dose of DI-Leu16-IL2 [ Time Frame: 6 weeks post cycle 1 of treatment ]
- Optimal biologic dose of DI-Leu16-IL2 [ Time Frame: 6 weeks after final cycle of treatment ]
- Toxicities associated with the DI-Leu16-IL2 regimen [ Time Frame: 6 weeks after final cycle of treatment ]
- Immunogenicity as a result of DI-Leu16-IL2 administration [ Time Frame: Within 2 weeks following a 4 week treatment period ]
- Pharmacokinetics of DI-Leu16-IL2 administration [ Time Frame: 6 weeks after final cycle of treatment ]
- Clinical responses and survival [ Time Frame: Within two weeks following completion of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720135
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||Ryotaro Nakamura||City of Hope Medical Center|