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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006478
Recruitment Status : Terminated (Genitope suspend drug development by decision made by the FDA March 6, 2008.)
First Posted : January 27, 2003
Results First Posted : November 17, 2010
Last Update Posted : September 4, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Julie M Vose, MD, University of Nebraska

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.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: autologous tumor cell vaccine Biological: keyhole limpet hemocyanin Biological: sargramostim Procedure: adjuvant therapy Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
Study Start Date : September 2000
Actual Primary Completion Date : March 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Primary Outcome Measures :
  1. Number of Participants With Humoral and Cellular Immune Response [ 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 ]
    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 :
  1. Safety [ Time Frame: At each immunization and at study completion ]
    To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting

  2. Toxicity [ Time Frame: At each immunization and at study completion ]
    To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting

  3. Changes in Quantitative Bcl-2 [ Time Frame: 1 year post transplant evaluation and then annually until disease progression ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 19

Performance status:

  • Karnofsky greater than 70%

Life expectancy:

  • Not specified


  • 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


  • 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


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation


Biologic therapy:

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006478

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United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805
Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
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Study Chair: Julie M. Vose, MD University of Nebraska
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Responsible Party: Julie M Vose, MD, Principal Investigator, University of Nebraska Identifier: NCT00006478    
Other Study ID Numbers: 260-00
P30CA036727 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: November 17, 2010
Last Update Posted: September 4, 2018
Last Verified: August 2018
Keywords provided by Julie M Vose, MD, University of Nebraska:
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Keyhole-limpet hemocyanin
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic