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

Lymphoma Clinical Trial

Official title:

Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006478
• Other study ID #: 0260-00-FB
• Secondary ID: 37-7109-2007-001
• Status: Terminated
• Phase: Phase 2
• Start date: October 11, 2000
• Est. completion date: April 3, 2008

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: April 3, 2008
• Est. primary completion date: April 3, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• autologous tumor cell vaccine

• keyhole limpet hemocyanin

• sargramostim

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Safety of Idiotype Vaccine	To evaluate the safety of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting	At each immunization and at study completion
Secondary	Toxicity of Idiotype Vaccine	To evaluate the toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting	At each immunization and at study completion
Secondary	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.	1 year post transplant evaluation and then annually until disease progression