NCT00006478

Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma

Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	autologous tumor cell vaccine
BIOLOGICAL	keyhole limpet hemocyanin
BIOLOGICAL	sargramostim
PROCEDURE	adjuvant therapy

Timeline

• Start date: 2000-10-11
• Primary completion: 2008-04-03
• Completion: 2008-04-03
• First posted: 2003-01-27
• Last updated: 2023-09-18
• Results posted: 2010-11-17

Locations

1 site across 1 country: United States