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Status:

UNKNOWN

Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma

Lead Sponsor:

Favrille

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with t...

Detailed Description

OBJECTIVES: * Determine the efficacy of immunotherapy comprising rituximab, autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™), and sargramostim (GM-CSF), in terms of response rate (pa...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:
  • Grade 1 or 2 follicular lymphoma
  • Tumor must be accessible to biopsy or biopsy material available for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™)
  • Measurable or evaluable disease after node biopsy
  • No mantle cell, marginal zone, MALT-type, small lymphocytic, or grade 3 follicular (follicular large cell) lymphoma
  • No CNS involvement with lymphoma
  • PATIENT CHARACTERISTICS:
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Platelet count \> 100,000/mm\^3
  • WBC ≥ 3,000/mm\^3
  • Hepatic
  • AST and ALT ≤ 2 times upper limit of normal
  • Bilirubin ≤ 2 mg/dL
  • Renal
  • Creatinine ≤ 1.5 mg/dL
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 30 days after completion of study treatment
  • HIV negative
  • No other medical or psychiatric disease that would preclude study compliance
  • No other malignancy (active or treated) within the past 5 years
  • PRIOR CONCURRENT THERAPY:
  • Radiotherapy
  • Prior local radiotherapy allowed
  • Other
  • No other prior anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    August 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    56 Patients enrolled

    Trial Details

    Trial ID

    NCT00258336

    Start Date

    August 1 2004

    Last Update

    January 10 2014

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Sarah Cannon Cancer Center at Centennial Medical Center

    Nashville, Tennessee, United States, 37203