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

August 1, 2013 updated by: Favrille

Phase II Trial of FavId™ (Patient-Specific Idiotype/KLH) and GM-CSF in Subjects Who Demonstrated Progressive Disease and Did Not Receive FavId on Study FavId-06

RATIONALE: Vaccines made from a person's cancer cells may make the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase II trial is studying how well giving vaccine therapy together with GM-CSF works in treating patients with progressive B-cell non-Hodgkin's lymphoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Provide treatment with autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ and sargramostim (GM-CSF) to patients with progressive grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who did not receive FavId™ while enrolled on protocol FAV-ID-06.

Secondary

  • Determine the response rate and duration of response in patients treated with this regimen.
  • Determine the response rate and response rate improvement after best response to prior salvage therapy in patients treated with this regimen.
  • Determine the time to progression in patients treated with this regimen.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to timing of disease progression while enrolled on protocol FAV-ID-06 (disease progression after prior rituximab AND never randomized vs disease progression after randomization to placebo arm).

Patients receive autologous immunoglobulin idiotype-KLH vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4. Treatment repeats monthly for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional treatment as above every 2 months for 1 year (6 treatments) and every 3 months until disease progression.

After completion of study treatment, patients are followed for 30 days or until the start of subsequent treatment.

PROJECTED ACCRUAL: Approximately 238 patients (67 in group I and 171 in group II) will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

238

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB Comprehensive Cancer Center
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Cancer Research Foundation
      • La Jolla, California, United States, 92093-0960
        • Rebecca and John Moores UCSD Cancer Center
      • Los Angeles, California, United States, 90048
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • San Diego, California, United States, 92120
        • Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital Cancer Center
      • San Francisco, California, United States, 94143-0324
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • Stanford, California, United States, 94305-5824
        • Stanford Cancer Center
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center - Vallejo
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers - Denver Midtown
    • Delaware
      • Newark, Delaware, United States, 19713
        • Helen F. Graham Cancer Center at Christiana Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Center for Hematology-Oncology - Boca Raton
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Cancer Center - Coeur d'Alene
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush Cancer Institute at Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Cancer Institute at Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Josephine Ford Cancer Center at Henry Ford Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • Montana
      • Missoula, Montana, United States, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Cancer Center
    • New York
      • Bronx, New York, United States, 10466-2604
        • Our Lady of Mercy Medical Center Comprehensive Cancer Center
      • Manhasset, New York, United States, 11030
        • Don Monti Comprehensive Cancer Center at North Shore University Hospital
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
      • Fargo, North Dakota, United States, 58122
        • Roger Maris Cancer Center at MeritCare Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Case Comprehensive Cancer Center
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Knight Cancer Institute at Oregon Health and Science University
      • Portland, Oregon, United States, 97213
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Medical Office - Interstate Medical Office Central
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center at Centennial Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cancer Care Centers of South Texas - Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Yakima, Washington, United States, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)

    • Grade 1, 2, or 3
  • Progressive disease AND did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™) while enrolled on protocol FAV-ID-06

  • Meets 1 of the following criteria:

    • Received salvage therapy after completion of protocol FAV-ID-06

      • At least 4 weeks, but no more than 4 months, since prior salvage therapy

    • Did not receive salvage therapy after completion of protocol FAV-ID-06

      • At least 4 weeks, but no more than 4 months, since completion of prior treatment on protocol FAV-ID-06
  • No history of CNS lymphoma OR meningeal lymphomatosis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No history of congestive heart failure

Pulmonary

  • No history of compromised pulmonary function

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active bacterial, viral, or fungal infection
  • No psychiatric disorder
  • No other serious nonmalignant disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No prior allogeneic transplantation*
  • No prior rituximab regimen* other than that administered on protocol FAV-ID-06 (rituximab 375 mg/m^2 IV weekly for 4 weeks)

Chemotherapy

  • No prior purine analogues* (e.g., fludarabine or cladribine)

Endocrine therapy

  • No prior or concurrent steroids (e.g., steroid doses in excess of daily replacement)

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Recovered from prior salvage therapy
  • No prior or concurrent immunosuppressive therapy
  • No prior investigational agents*
  • No other concurrent antilymphoma therapy NOTE: *As salvage therapy administered between completion of protocol FAV-ID-06 and enrollment onto this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ provided to patients who did not receive autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId)™ during participation on study Favld-06

Secondary Outcome Measures

Outcome Measure
Time to progression
Response rate by modified Cheson Criteria
Duration of response by modified Cheson Criteria
Response rate improvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Favrille

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: John F. Bender, PharmD, Favrille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAV-ID-09
  • CDR0000415573 (Registry Identifier: PDQ (Physician Data Query))
  • CWRU-FVID-2404
  • CWRU-100415
  • CASE-2404
  • FAV-WIRB-20041124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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