Non Hodgkin Lymphoma Clinical Trial
Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating 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.
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.
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
Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation
Not pregnant or nursing/negative pregnancy test
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There is 1 Location for this study
Omaha Nebraska, 68198, United States
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