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LymphomaPhase 3NCT00089115

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

A Phase 3 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine, rituximab and sargramostim in people with Lymphoma, run by Favrille at 60 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
autologous immunoglobulin idiotype-KLH conjugate vaccine, rituximab and sargramostim
Type of treatment
Vaccines
How many people
Not given
Where
60 sitesUnited States
Study dates
Jul 2004to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • New Mexico Cancer Center

    Albuquerque, New Mexico, 87109

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204-6881

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Mid Dakota Clinic, P. C.

    Bismarck, North Dakota, 58502-5538

  • Center for Hematology-Oncology - Boca Raton

    Boca Raton, Florida, 33486

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

    Boston, Massachusetts, 02115

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45219

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

    Cleveland, Ohio, 44106-5047

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • North Idaho Cancer Center

    Coeur d'Alene, Idaho, 83814

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

    Columbus, Ohio, 43210-1240

  • Baylor University Medical Center - Dallas

    Dallas, Texas, 75246

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-0001

  • Rocky Mountain Cancer Centers - Denver Midtown

    Denver, Colorado, 80218

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202-2608

  • Roger Maris Cancer Center at MeritCare Hospital

    Fargo, North Dakota, 58122

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • University of Florida Health Science Center - Jacksonville

    Jacksonville, Florida, 32209

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

    Kansas City, Kansas, 66160-7357

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59802

  • Sarah Cannon Cancer Center at Centennial Medical Center

    Nashville, Tennessee, 37203

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center - Philipps Ambulatory Care Center

    New York, New York, 10003

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

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

    Newark, Delaware, 19713-2055

  • Hoag Cancer Center at Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • Fox Chase-Temple Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213

  • Kaiser Permanente Medical Office - Interstate Medical Office Central

    Portland, Oregon, 97227

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

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

    Rochester, New York, 14642

  • Cancer Care Network of South Texas

    San Antonio, Texas, 78229

  • Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego

    San Diego, California, 92120

  • Sharp Memorial Hospital Cancer Center

    San Diego, California, 92123

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0324

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98104

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Cancer Center at Stanford University Medical Center

    Stanford, California, 94305

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

    Tampa, Florida, 33612-9497

  • Our Lady of Mercy Medical Center Comprehensive Cancer Center

    The Bronx, New York, 10466-2604

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Lombardi Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Phase III, Randomized, Double Blind, Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular B-Cell Non-Hodgkin's Lymphoma

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.

Read the detailed description

OBJECTIVES:

Primary

  • Compare time to disease progression in patients with grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who respond (i.e., complete or partial response, or stable disease) to treatment with rituximab and are then treated with sargramostim (GM-CSF) with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine.

Secondary

  • Compare response rate improvement in patients treated with these regimens.
  • Compare overall complete response rate in patients treated with these regimens.
  • Compare duration of response in patients treated with these regimens.
  • Determine the safety of these regimens in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior treatment (yes vs no) and response to rituximab during study (complete response [CR] or partial response [PR] vs stable disease [SD]).

All patients receive rituximab IV once weekly for 4 weeks. Five weeks after the last dose of rituximab, patients are assessed for response. Patients with progressive disease are removed from the study and do not undergo randomization. Patients with a CR, PR, or SD are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4.
  • Arm II: Patients receive placebo SC on day 1. Patients also receive GM-CSF SC on days 1-4.

In both arms, treatment repeats monthly for 6 months in the absence of unacceptable toxicity or clinically significant progressive disease. After the first 6 months, patients with a CR, PR, or SD may continue to receive treatment (per treatment arm as above) every 2 months for 1 year (total of 6 doses) and then every 3 months thereafter in the absence of disease progression.

Patients are followed every 3 months for 2 years and then every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 342 evaluable patients (171 per treatment arm) will be accrued for this study within 18 months.

Conditions
Lymphoma
Being tested
autologous immunoglobulin idiotype-KLH conjugate vaccine, rituximab, sargramostim
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
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • autologous immunoglobulin idiotype-KLH conjugate vaccineBiological

  • rituximabBiological

  • sargramostimBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression after 248 patients have progressed

Secondary outcomes (4)

  1. Response rate improvement after 248 patients have progressed

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2004 (estimated)
  2. Study startJul 2004

Why it stopped: Withdrawn as company has shut down and filed for bankruptcy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089115
Sponsor's protocol ID
FAV-ID-06
Other IDs
CDR0000378046, FAV-WIRB-20040335, CWRU-FVID-1404
Status last verified
Feb 2006
First submitted
4 Aug 2004
Last updated
2 Aug 2013
Results posted
No

Publications

  • 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.

    PubMed 19414675

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing autologous immunoglobulin idiotype-KLH conjugate vaccine, rituximab and sargramostim in people with Lymphoma, run by Favrille at 60 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Withdrawn as company has shut down and filed for bankruptcy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression after 248 patients have progressed. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00089115, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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