Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
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.
Biological: autologous tumor cell vaccine
Biological: keyhole limpet hemocyanin
Procedure: adjuvant therapy
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2000|
|Study Completion Date:||April 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|