Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00006478|
Recruitment Status : Terminated (Genitope suspend drug development by decision made by the FDA March 6, 2008.)
First Posted : January 27, 2003
Results First Posted : November 17, 2010
Last Update Posted : September 4, 2018
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Vaccine therapy may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: autologous tumor cell vaccine Biological: keyhole limpet hemocyanin Biological: sargramostim Procedure: adjuvant therapy||Phase 2|
- Determine the humoral and cellular immune responses in patients with follicular non-Hodgkin's lymphoma treated with autologous lymphoma-derived idiotype vaccine with keyhole limpet hemocyanin plus sargramostim (GM-CSF).
- Determine the safety and toxicity of this regimen in these patients in the post-transplant setting.
- Determine the changes in quantitative bcl-2 in the blood and bone marrow of these patients before and at various times after the series of idiotype vaccines.
OUTLINE: Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma|
|Study Start Date :||September 2000|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||April 2008|
- Number of Participants With Humoral and Cellular Immune Response [ Time Frame: immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression ]evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation
- Safety [ Time Frame: At each immunization and at study completion ]To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
- Toxicity [ Time Frame: At each immunization and at study completion ]To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
- Changes in Quantitative Bcl-2 [ Time Frame: 1 year post transplant evaluation and then annually until disease progression ]To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.
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): NCT00006478
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|Study Chair:||Julie M. Vose, MD||University of Nebraska|