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

This study is currently recruiting patients.

Sponsored by: University of Nebraska
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
 Drug: autologous tumor cell vaccine
 Drug: keyhole limpet hemocyanin
 Drug: sargramostim
 Procedure: adjuvant therapy
 Procedure: biological response modifier therapy
 Procedure: non-specific immune-modulator therapy
 Procedure: tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Pilot Study of Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation in Patients With Follicular Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

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 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

Location and Contact Information


Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States; Recruiting
Julie M. Vose, MD  402-559-3848    jmvose@unmc.edu 

Study chairs or principal investigators

Julie M. Vose, MD,  Study Chair,  University of Nebraska   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068307; UNMC-260-00; GENITOPE-IND-8294; NCT00006478
Record last reviewed:  April 2001
Last Updated:  February 4, 2005
Record first received:  November 6, 2000
ClinicalTrials.gov Identifier:  NCT00006478
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005