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Vaccine Therapy and GM-CSF in Treating Patients With Progressive Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008
Sponsors and Collaborators: Favrille
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00104819
  Purpose

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.


Condition Intervention Phase
Lymphoma
 Drug: autologous immunoglobulin idiotype-KLH conjugate vaccine
Drug: sargramostim
 Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: 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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate by modified Cheson Criteria [ Designated as safety issue: No ]
  • Duration of response by modified Cheson Criteria [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Response rate improvement [ Designated as safety issue: No ]

Estimated Enrollment: 238
Study Start Date: September 2004
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104819

  Show 51 Study Locations
Sponsors and Collaborators
Favrille
National Cancer Institute (NCI)
Investigators
Study Chair: John F. Bender, PharmD Favrille
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000415573, FAV-ID-09, CWRU-FVID-2404, CWRU-100415, CASE-2404, FAV-WIRB-20041124
Study First Received: March 3, 2005
Last Updated: November 21, 2008
ClinicalTrials.gov Identifier: NCT00104819  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma

Study placed in the following topic categories:
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Immunoglobulin Idiotypes
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
 Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma
Recurrence
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
 Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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