Vaccine Therapy in Treating Patients With Recurrent B-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00561756|
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : November 17, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: plasmid DNA vaccine therapy Other: flow cytometry Other: immunoenzyme technique||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial to Assess Safety and Immunogenicity of Xenogeneic CD20 DNA Vaccination With Patients With B-Cell Lymphoma|
|Study Start Date :||October 2007|
|Primary Completion Date :||November 2015|
|Study Completion Date :||November 2015|
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|
- Safety and immunogenicity [ Time Frame: 2 years ]
- Antibody and T-cell responses against CD20 [ Time Frame: 2 years ]
- Antitumor response [ Time Frame: 2 years ]
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): 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|