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

NCT ID: NCT00006478

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-11
• Study Completion Date: 2008-04-03

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation

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.

Group Type: EXPERIMENTAL

autologous tumor cell vaccine

Intervention Type: BIOLOGICAL

keyhole limpet hemocyanin

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

adjuvant therapy

Intervention Type: PROCEDURE

Interventions

autologous tumor cell vaccine

Intervention Type: BIOLOGICAL

keyhole limpet hemocyanin

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

adjuvant therapy

Intervention Type: PROCEDURE

Other Intervention Names

Leukine

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)
• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie M Vose, MD

Role: STUDY_CHAIR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

37-7109-2007-001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GENITOPE-IND-8294

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0260-00-FB

Identifier Type: -

Identifier Source: org_study_id