Vaccine Therapy in Treating Patients With Recurrent B-Cell Lymphoma
RATIONALE: Vaccines made from mouse DNA may help the body build an effective immune response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of mouse DNA vaccine in treating patients with recurrent B-cell lymphoma.
Biological: plasmid DNA vaccine therapy
Other: flow cytometry
Other: immunoenzyme technique
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial to Assess Safety and Immunogenicity of Xenogeneic CD20 DNA Vaccination With Patients With B-Cell Lymphoma|
- Safety and immunogenicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Antibody and T-cell responses against CD20 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Antitumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Vaccine Therapy
This single arm, open-label, phase I clinical trial of xenogeneic CD20 DNA vaccination is designed to evaluate its safety in patients with B cell lymphoma. The study is a dose escalation study at three test doses, 0.5 mg, 2 mg and 4 mg of purified plasmid DNA per injection. There will be an initial cohort of three patients receiving a pre-level 1 dose of 0.1 mg/vaccination before proceeding to the three test doses.
|Biological: plasmid DNA vaccine therapy Other: flow cytometry Other: immunoenzyme technique|
- To evaluate the safety and feasibility of intramuscular DNA vaccination with a plasmid DNA vector expressing the mouse extracellular domain of CD20, namely pINGmminiCD20. Doses of pING-mminiCD20 will be escalated by group to determine the optimal biological dose.
- To evaluate antibody and T-cell responses to CD20 after vaccination.
- To observe patients for evidence of any antitumor response generated after vaccination.
OUTLINE: The entire immunization schedule comprises five injections administered every three weeks (for a total of approximately four and one half months). After the second injection, blood will be drawn for assessment of antibody and T-cell responses. After the fifth and final injection, blood will again be drawn for assessment of antibody and T-cell responses.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561756
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||M. Lia Palomba, MD||Memorial Sloan Kettering Cancer Center.|
|Principal Investigator:||Andrew D. Zelenetz, MD, PhD||Memorial Sloan Kettering Cancer Center.|
|Principal Investigator:||Alan N. Houghton, MD||Memorial Sloan Kettering Cancer Center.|