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

Phase 2

Terminated

Conditions: Lymphoma

Interventions: Biological: autologous tumor cell vaccine
Biological: keyhole limpet hemocyanin
Biological: sargramostim
Procedure: adjuvant therapy

Registration Number: NCT00006478

Lead Sponsor: University of Nebraska

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation	autologous tumor cell vaccine	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.
Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation	sargramostim	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.
Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation	adjuvant therapy	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.
Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation	keyhole limpet hemocyanin	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Humoral and Cellular Immune Response	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 Outcome Measures

Name	Time	Method
Safety of Idiotype Vaccine	At each immunization and at study completion	To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Changes in Quantitative Bcl-2	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.
Toxicity of Idiotype Vaccine	At each immunization and at study completion	To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting