Fusion Protein Cytokine Therapy After Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma

This study is currently recruiting participants.
Verified August 2012 by City of Hope Medical Center

First Received on July 19, 2008.  
Last Updated on August 9, 2012  
History of Changes
This Clinical Trial Sponsored By: City of Hope Medical Center
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00720135
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial 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

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety Study
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 Lymphoma

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Lymphoma
Drug Information available for:
Rituximab

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures For Clinical Trial:

  • Maximum tolerated dose of DI-Leu16-IL2 [ Time Frame: 6 weeks post cycle 1 of treatment ] [ Designated as safety issue: Yes ]
  • Optimal biologic dose of DI-Leu16-IL2 [ Time Frame: 6 weeks after final cycle of treatment ] [ Designated as safety issue: Yes ]
  • Toxicities associated with the DI-Leu16-IL2 regimen [ Time Frame: 6 weeks after final cycle of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures For Clinical Trial:

  • Immunogenicity as a result of DI-Leu16-IL2 administration [ Time Frame: Within 2 weeks following a 4 week treatment period ] [ Designated as safety issue: No ]
  • Pharmacokinetics of DI-Leu16-IL2 administration [ Time Frame: 6 weeks after final cycle of treatment ] [ Designated as safety issue: No ]
  • Clinical responses and survival [ Time Frame: Within two weeks following completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2008
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

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 6-7 weeks for up to a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Biological: DI-Leu16-IL2 immunocytokine

Given IV
Other Names:
  • de-immunized anti-CD20-IL-2 immunocytokine DI-Leu16-IL-2
  • DI-Leu16-IL-2

Biological: rituximab

Given IV
Other Names:
  • C2B8 Monoclonal Antibody
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan

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

Detailed Description:

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 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.

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