Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

NCT00089115 | Terminated Phase 3

• 4 other identifiers: FAV-ID-06CDR0000378046FAV-WIRB-20040335CWRU-FVID-1404
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 60

Brief Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with vaccine therapy may cause a stronger immune response and kill more cancer cells. PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

• Time to progression after 248 patients have progressed

Secondary Outcomes (4)

• Response rate improvement after 248 patients have progressed

• Overall complete response rate by modified Cheson Criteria after 248 patients have progressed

• Duration of response by modified Cheson Criteria after 248 patients have progressed

• Safety by Common Toxicity Criteria (CTC) after 248 patients have progressed

Interventions

autologous immunoglobulin idiotype-KLH conjugate vaccine BIOLOGICAL

rituximab 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 * Meets 1 of the following criteria for treatment with rituximab: * Treatment naïve * Relapsed or refractory disease after prior chemotherapy * Relapsed after a prior documented response (i.e., complete or partial response) to rituximab of at least 6 months duration * Tumor accessible for biopsy OR existing biopsy material (taken within the past 6 months) suitable for vaccine preparation * Measurable or evaluable disease after tumor tissue procurement for vaccine production * No more than 2 prior treatment regimens for NHL * Single regimens include any of the following: * Maintenance rituximab * Rituximab administered once weekly for 8 courses * Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab\* NOTE: \*CHOP followed by rituximab at time of relapse is considered 2 treatment regimens * No history of CNS lymphoma or meningeal lymphomatosis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 (unless related to bone marrow involvement by lymphoma) * Hemoglobin ≥ 10g/dL Hepatic * Not specified Renal * Not specified Cardiovascular * No congestive heart failure Pulmonary * No compromised pulmonary function Immunologic * HIV negative * No prior allergic response to GM-CSF * No active bacterial, viral, or fungal infection Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychiatric disorder that would preclude study participation * No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious nonmalignant disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * See Chemotherapy * At least 4 weeks since prior immunotherapy * No prior radiolabeled anti-lymphoma antibody (e.g., iodine I 131 tositumomab or ibritumomab tiuxetan) * No prior autologous or allogeneic stem cell transplantation * No prior lymphoma-specific idiotype immunotherapy (e.g., Id vaccine) * No prior investigational vaccine or immunotherapeutic containing keyhole limpet hemocyanin (KLH) Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy * More than 9 months since prior fludarabine * More than 2 years since prior chemotherapy/rituximab combination therapy (e.g., CHOP/rituximab or cyclophosphamide, vincristine, and prednisone \[CVP\]/rituximab) * No more than 6 total prior treatment courses with fludarabine Endocrine therapy * No concurrent steroids for allergic reaction to sargramostim (GM-CSF) Radiotherapy * See Biologic therapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * At least 4 weeks since prior experimental therapy * No concurrent systemic immunosuppressive therapy * No other concurrent anti-lymphoma therapy

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

Sponsors & Collaborators

• Favrille: lead

Study Sites (60)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089, United States

Location

Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, 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 Comprehensive Cancer Center

San Francisco, California, 94143-0324, United States

Location

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305, 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

Medical Oncology Hematology Consultants, P.A. at Helen F. Graham Cancer Center

Newark, Delaware, 19713-2055, United States

Location

Lombardi 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

University of Florida Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

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

Tampa, Florida, 33612-9497, United States

Location

North Idaho Cancer Center

Coeur d'Alene, Idaho, 83814, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

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

Kansas City, Kansas, 66160-7357, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

Ochsner Cancer Institute at Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204-6881, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, 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

St Louis, Missouri, 63110, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59802, United States

Location

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Beth Israel Medical Center - Philipps Ambulatory Care Center

New York, New York, 10003, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, 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

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Mid Dakota Clinic, P. C.

Bismarck, North Dakota, 58502-5538, 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

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106-5047, 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

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

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Fox Chase-Temple Cancer Center

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

Baylor University Medical Center - Dallas

Dallas, Texas, 75246, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Cancer Care Network of South Texas

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 Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (1)

• Freedman A, Neelapu SS, Nichols C, Robertson MJ, Djulbegovic B, Winter JN, Bender JF, Gold DP, Ghalie RG, Stewart ME, Esquibel V, Hamlin P. Placebo-controlled phase III trial of patient-specific immunotherapy with mitumprotimut-T and granulocyte-macrophage colony-stimulating factor after rituximab in patients with follicular lymphoma. J Clin Oncol. 2009 Jun 20;27(18):3036-43. doi: 10.1200/JCO.2008.19.8903. Epub 2009 May 4.

  PMID: 19414675 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

Rituximab; 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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John F. Bender, PharmD

  Favrille

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: July 1, 2004
• Last Updated: August 2, 2013

Record last verified: 2006-02

Locations

US (60)