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

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	Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: sargramostim	Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim 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

Additional Information:

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

No publications provided

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:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00104819 History of Changes
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:

Immunoproliferative Disorders
Immunoglobulin Idiotypes
Immunologic Factors
Lymphoma, Follicular
Follicular Lymphoma
Recurrence
Lymphoma, Small Cleaved-cell, Diffuse

Lymphatic Diseases
Antibodies
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immunologic Factors
Immunoglobulin Idiotypes

Immune System Diseases
Physiological Effects of Drugs
Lymphoproliferative Disorders
Lymphoma
Pharmacologic Actions
Immunoglobulins

ClinicalTrials.gov processed this record on May 07, 2009