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

This study has been terminated.
(Genitope suspend development of MyVax in light of the decision made by the Food and Drug Administration (FDA) March 6, 2008)
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00006478
First received: November 6, 2000
Last updated: March 1, 2011
Last verified: March 2011
  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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At each immunization and at study completion ] [ Designated as safety issue: Yes ]
    To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting

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

  • Changes in Quantitative Bcl-2 [ Time Frame: 1 year post transplant evaluation and then annually until disease progression ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: September 2000
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006478

Locations
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
Investigators
Study Chair: Julie M. Vose, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Julie M. Vose, UNMC Eppley Cancer Center at the University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00006478     History of Changes
Other Study ID Numbers: 260-00, P30CA036727, UNMC-260-00, GENITOPE-IND-8294
Study First Received: November 6, 2000
Results First Received: October 19, 2010
Last Updated: March 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Nebraska:
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014