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

NCT00104819 | Terminated Phase 2

• 6 other identifiers: FAV-ID-09CDR0000415573CWRU-FVID-2404CWRU-100415CASE-2404FAV-WIRB-20041124
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 51

Brief 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.

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Response rate by modified Cheson Criteria

• Duration of response by modified Cheson Criteria

• Time to progression

• Response rate improvement

Interventions

autologous immunoglobulin idiotype-KLH conjugate vaccine BIOLOGICAL

sargramostim BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Favrille: lead
• National Cancer Institute (NCI): collaborator

Study Sites (51)

UAB Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0960, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

Sharp Memorial Hospital Cancer Center

San Diego, California, 92123, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143-0324, United States

Location

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

Rocky Mountain Cancer Centers - Denver Midtown

Denver, Colorado, 80218, United States

Location

Helen F. Graham Cancer Center at Christiana Hospital

Newark, Delaware, 19713, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Center for Hematology-Oncology - Boca Raton

Boca Raton, Florida, 33486, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Kootenai Cancer Center - Coeur d'Alene

Coeur d'Alene, Idaho, 83814, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush Cancer Institute at Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Greater Baltimore Medical Center Cancer Center

Baltimore, Maryland, 21204, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202-2608, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

Location

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, 10466-2604, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501, United States

Location

Roger Maris Cancer Center at MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45219, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210-1240, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Kaiser Permanente Medical Office - Interstate Medical Office Central

Portland, Oregon, 97227, United States

Location

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, 17822-0001, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Cancer Care Centers of South Texas - Medical Center

San Antonio, Texas, 78229, United States

Location

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98104, United States

Location

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Study Officials

• John F. Bender, PharmD

  Favrille

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: September 1, 2004
• Primary Completion: June 1, 2011
• Last Updated: August 2, 2013

Record last verified: 2008-08

Locations

US (51)