Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Lymphoma
- Sponsor
- University of Nebraska
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Number of Participants With Humoral and Cellular Immune Response
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Over 19 years of age
- •Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy
- •Minimal disease state at day 100 to 6 months post-transplantatio
- •Lymph nodes smaller than 2 centimeters (cm)
- •Less than 20% bone marrow involvement with lymphoma
- •Uncertain complete remission, defined by greater than 75% reduction in the size of the pre-transplantation mass not representing active disease
- •Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy
- •o Must have adequate circulating lymphoma cells
- •Karnofsky greater than 70%
- •Absolute neutrophil count greater than 1,000/mm\^3 (No restrictions if study vaccine administered at 6 months after transplantation)
Exclusion Criteria
- •Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation
- •Not pregnant or nursing/negative pregnancy test
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Safety of Idiotype Vaccine(At each immunization and at study completion)
- Changes in Quantitative Bcl-2(1 year post transplant evaluation and then annually until disease progression)
- Toxicity of Idiotype Vaccine(At each immunization and at study completion)