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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: autologous tumor cell vaccine
* Biological: keyhole limpet hemocyanin
* Biological: sargramostim
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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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) CD4+ count greater than 200/microliter (No restrictions if study vaccine administered at 6 months after transplantation) Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement) Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 2 times normal (unless due to lymphomatous involvement) Creatinine no greater than 2.0 mg/dL Fertile patients must use effective contraception during and for 6 months after study participation Exclusion Criteria: Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation Not pregnant or nursing/negative pregnancy test

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation<br>Phase II trial to study the effectiveness, safety & toxicity of vaccine therapy following chemotherapy and peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma. Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Participants 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. | Biological: autologous tumor cell vaccine<br> <br> Biological: keyhole limpet hemocyanin<br> <br> Biological: sargramostim<br> <br> * Other names: Leukine;Procedure: adjuvant therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Humoral and Cellular Immune Response | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Idiotype Vaccine | To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting | At each immunization and at study completion | 
| Toxicity of Idiotype Vaccine | To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting | At each immunization and at study completion | 
| Changes in Quantitative Bcl-2 | 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. | 1 year post transplant evaluation and then annually until disease progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma