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

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
autologous tumor cell vaccine
keyhole limpet hemocyanin
sargramostim
adjuvant therapy
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety of Idiotype Vaccine
To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Toxicity of Idiotype Vaccine
To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
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.

Full Information

First Posted
November 6, 2000
Last Updated
August 22, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT00006478
Brief Title
Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma
Official Title
Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Genitope suspend drug development by decision made by the FDA March 6, 2008.
Study Start Date
October 11, 2000 (Actual)
Primary Completion Date
April 3, 2008 (Actual)
Study Completion Date
April 3, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effectiveness of Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
autologous tumor cell vaccine
Intervention Type
Biological
Intervention Name(s)
keyhole limpet hemocyanin
Intervention Type
Biological
Intervention Name(s)
sargramostim
Other Intervention Name(s)
Leukine
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Number of Participants With Humoral and Cellular Immune Response
Description
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
Time Frame
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 Measure Information:
Title
Safety of Idiotype Vaccine
Description
To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Time Frame
At each immunization and at study completion
Title
Toxicity of Idiotype Vaccine
Description
To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting
Time Frame
At each immunization and at study completion
Title
Changes in Quantitative Bcl-2
Description
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.
Time Frame
1 year post transplant evaluation and then annually until disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie M Vose, MD
Organizational Affiliation
University of Nebraska
Official's Role
Study Chair
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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