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Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00006478   Information provided by National Cancer Institute (NCI)
First Received: November 6, 2000   Last Updated: February 6, 2009   History of Changes

November 6, 2000
February 6, 2009
September 2000
April 2008   (final data collection date for primary outcome measure)
  • Humoral and cellular immune response [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Changes in quantitative bcl-2 levels [ Designated as safety issue: No ]
  • Humoral and cellular immune response
  • Safety
  • Toxicity
  • Changes in quantitative bcl-2 levels
Complete list of historical versions of study NCT00006478 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma

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.

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.

Phase II
Interventional
Treatment
Lymphoma
  • Biological: autologous tumor cell vaccine
  • Biological: keyhole limpet hemocyanin
  • Biological: sargramostim
  • Procedure: adjuvant therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
20
 
April 2008   (final data collection date for primary outcome measure)

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 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)
  • SGOT and 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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006478
Julie M. Vose, UNMC Eppley Cancer Center at the University of Nebraska Medical Center
CDR0000068307, UNMC-260-00, GENITOPE-IND-8294
University of Nebraska
 
Study Chair: Julie M. Vose, MD University of Nebraska
National Cancer Institute (NCI)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP