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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00104819
• Other study ID #: FAV-ID-09
• Secondary ID: CDR0000415573CWR
• Status: Terminated
• Phase: Phase 2
• First received: March 3, 2005
• Last updated: August 1, 2013
• Start date: September 2004

Study information

• Verified date: August 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 238
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• autologous immunoglobulin idiotype-KLH conjugate vaccine

• sargramostim

Locations

Country	Name	City	State
United States	New Mexico Cancer Center	Albuquerque	New Mexico
United States	Greater Baltimore Medical Center Cancer Center	Baltimore	Maryland
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	UAB Comprehensive Cancer Center	Birmingham	Alabama
United States	Mid Dakota Clinic, PC	Bismarck	North Dakota
United States	Center for Hematology-Oncology - Boca Raton	Boca Raton	Florida
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Rush Cancer Institute at Rush University Medical Center	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Kootenai Cancer Center - Coeur d'Alene	Coeur d'Alene	Idaho
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio
United States	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania
United States	Rocky Mountain Cancer Centers - Denver Midtown	Denver	Colorado
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Roger Maris Cancer Center at MeritCare Hospital	Fargo	North Dakota
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky
United States	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Don Monti Comprehensive Cancer Center at North Shore University Hospital	Manhasset	New York
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Sarah Cannon Cancer Center at Centennial Medical Center	Nashville	Tennessee
United States	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Helen F. Graham Cancer Center at Christiana Hospital	Newark	Delaware
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Kaiser Permanente Medical Office - Interstate Medical Office Central	Portland	Oregon
United States	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	Cancer Care Centers of South Texas - Medical Center	San Antonio	Texas
United States	Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego	San Diego	California
United States	Sharp Memorial Hospital Cancer Center	San Diego	California
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	Stanford Cancer Center	Stanford	California
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Favrille	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	Response rate by modified Cheson Criteria			No
Secondary	Duration of response by modified Cheson Criteria			No
Secondary	Time to progression			No
Secondary	Response rate improvement			No