Expired Study
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Omaha, Nebraska 68198


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy - Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation - Minimal disease state at day 100 to 6 months post-transplantation - 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 - Must have adequate circulating lymphoma cells PATIENT CHARACTERISTICS: Age: - Over 19 Performance status: - Karnofsky greater than 70% Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - Absolute neutrophil count greater than 1,000/mm^3* - CD4+ count greater than 200/microliter* NOTE: *No restrictions if study vaccine administered at 6 months after transplantation Hepatic: - 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) Renal: - Creatinine no greater than 2.0 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified


NCT ID:

NCT00006478


Primary Contact:

Study Chair
Julie M. Vose, MD
University of Nebraska


Backup Contact:

N/A


Location Contact:

Omaha, Nebraska 68198
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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