Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma (BiovaxID)
clinicaltrials.gov
This study is currently recruiting participants.
Verified by Biovest International, November 2007
Sponsored by: Biovest International
Information provided by: Biovest International
ClinicalTrials.gov Identifier: NCT00091676
Purpose
The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission.
Condition Intervention Phase
Non-Hodgkins Lymphoma
Biological: tumor specific immune response
Biological: control vaccine
Phase III
MedlinePlus related topics: Lymphoma
ChemIDplus related topics: Sargramostim Granulocyte-macrophage colony-stimulating factor Regramostim Chlordiazepoxide Trichloroethylene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission
Further study details as provided by Biovest International:
Primary Outcome Measures:
To demonstrate prolongation of the period of Disease Free Survival (significant prolongation of the period of complete remission) in idiotype vaccine treated patients [ Time Frame: until date of relapse ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
To determine the ability of the idiotype vaccine to produce a molecular complete remission [ Time Frame: once subject achieves molecular CR ] [ Designated as safety issue: No ]
To determine the impact of molecular disease free survival [ Time Frame: until relapse ] [ Designated as safety issue: No ]
To assess the ability of the idiotype vaccine to generate an immunologic response against the NHL tumor [ Time Frame: varies ] [ Designated as safety issue: No ]
To compare the overall survival of subjects randomized to receive either treatment [ Time Frame: minimum 5 years from last subject randomized ] [ Designated as safety issue: No ]
To confirm the safety of 5 monthly injections of the vaccine with GM-CSF [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 629
Study Start Date: February 2000
Estimated Study Completion Date: March 2009
Arms Assigned Interventions
1: Experimental Biological: tumor specific immune response
5 vaccinations over a 6 month time period
2: Active Comparator Biological: control vaccine
5 vaccinations over a 6 month time period
Detailed Description:
Patients with Stage III-IV follicular lymphoma and tumor > 2cm (Stage II allowed if tumor > 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Criteria
Inclusion/Exclusion Criteria:
Diagnosis of indolent follicular lymphoma(follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes) with surface IgM or IgG phenotype.
Stage III-IV with lymph node > 2cm or Stage II with lymph node > 5 cm
No prior chemotherapy other than local radiation (not greater than 2 sites)
ECOG < 2
Survival > 1 yr
Serum creatinine < 1.5 mg/dl
Bilirubin <1.5 mg/dl
SGOT/SGPT < 3.5 ULN
No HIV antibodies or HBV antigen
Negative pregnancy screen (females)
No unrelated neoplasm in the previous 10 years
No evidence of primary or secondary CNS lymphoma
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091676
Contacts
Contact: Christine McCague 910-772-7329 christine.mccague@wilm.ppdi.com
Locations
United States, Florida
Cancer and Blood Disease Center Recruiting
Lecanto, Florida, United States, 34461
Contact: Joyce Winder, RN 352-746-0707 trials@tampabay.rr.com
Principal Investigator: Gustavo Fonseca, M.D.
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Stacy Moss 813-745-8391 mosssl@moffitt.usf.edu
Principal Investigator: Gregoire Bergier, MD
United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Courtney Johnson 404-778-3575 courtney.johnson@emoryhealthcare.org
Principal Investigator: Christopher Flowers, MD
United States, Hawaii
Hawaii Pacific Health Research Institute Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Lori Keith 808-547-5925
Principal Investigator: Ian Okazaki, MD
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center-Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: David Patton, CCRC 312-695-4538 d-patton2@northwestern.edu
Principal Investigator: Jane Winter, M.D.
United States, Maryland
National Cancer Institute Active, not recruiting
Bethesda, Maryland, United States, 20892
National Naval Medical Center Active, not recruiting
Bethesda, Maryland, United States, 20889
United States, Massachusetts
Tufts University Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Jamie Hill 617-636-4998 jhill@tufts-nemc.org
Principal Investigator: Andreas Klein, MD
United States, Minnesota
Duluth Clinic Cancer Center Active, not recruiting
Duluth, Minnesota, United States, 55805
United States, Mississippi
North Missippi Hem & Onc Associates Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Marthe Thomas, RN 662-844-9166 mthomas_nmho@dixie-net.com
Principal Investigator: Christopher Croot, M.D.
United States, New York
NYU School of Medicine Cancer Institute Recruiting
New York, New York, United States, 10016
Contact: Andrea Downey, RN 212-263-5466 andrea.downey@nyumc.org
Principal Investigator: Franco Muggia, M.D.
Westchester Oncology and Hematology Recruiting
Hawthorne, New York, United States, 10532
Contact: Judy Laumuanopuii, MD 914-594-4000 ext 111
Principal Investigator: Tauseef Ahmed, MD
United States, North Carolina
Duke Comprehensive Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Contact: Sue Roth 919-681-4769 roth0003@mc.duke.edu
Principal Investigator: Jon Gockerman, M.D.
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brenda Horn 215-617-1812 brenda.horn@upenn.edu
Principal Investigator: Stephen Schuster, M.D.
United States, Texas
Univeristy of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Kim Hartig 713-792-4249 khartig@mdanderson.org
Principal Investigator: Sattva Neelapu, MD
United States, Virginia
Virginia Oncology Associates Active, not recruiting
Norfolk, Virginia, United States, 23502
United States, Washington
Puget Sound Cancer Centers Recruiting
Seattle, Washington, United States, 98133
Contact: Karen Zapata, RN 206-365-8252 karen.zapata@usoncology.com
Principal Investigator: David Dong, MD
Sponsors and Collaborators
Biovest International
Investigators
Study Director: Angelos Stergiou, MD Biovest International
Principal Investigator: Jon Gockerman, MD Duke University
More Information
Related Info
Publications:
Hsu FJ, Caspar CB, Czerwinski D, Kwak LW, Liles TM, Syrengelas A, Taidi-Laskowski B, Levy R. Tumor-specific idiotype vaccines in the treatment of patients with B-cell lymphoma--long-term results of a clinical trial. Blood. 1997 May 1;89(9):3129-35.
Bendandi M, Gocke CD, Kobrin CB, Benko FA, Sternas LA, Pennington R, Watson TM, Reynolds CW, Gause BL, Duffey PL, Jaffe ES, Creekmore SP, Longo DL, Kwak LW. Complete molecular remissions induced by patient-specific vaccination plus granulocyte-monocyte colony-stimulating factor against lymphoma. Nat Med. 1999 Oct;5(10):1171-7.
Kwak LW, Campbell MJ, Czerwinski DK, Hart S, Miller RA, Levy R. Induction of immune responses in patients with B-cell lymphoma against the surface-immunoglobulin idiotype expressed by their tumors. N Engl J Med. 1992 Oct 22;327(17):1209-15.
Dar MM, Kwak LW. Vaccination strategies for lymphomas. Curr Oncol Rep. 2003 Sep;5(5):380-6. Review.
Responsible Party: Biovest International ( Angelos Stergiou, MD/Executive Director )
Study ID Numbers: BV 301
First Received: September 15, 2004
Last Updated: November 29, 2007
ClinicalTrials.gov Identifier: NCT00091676
Health Authority: United States: Food and Drug Administration
Keywords provided by Biovest International:
follicular
lymphoma
Non-Hodgkins
idiotype
vaccine
indolent follicular Non-Hodgkins Lymphoma
tumor-derived
B-cell
cancer
Study placed in the following topic categories:
Immunoproliferative Disorders
Immunoglobulin Idiotypes
Lymphoma, Diffuse
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphatic Diseases
Lymphoma, Small Cleaved-Cell, Diffuse
Trichloroethylene
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma, Intermediate-Grade
Chlordiazepoxide
Lymphoma
Lymphoma, Small-Cell
Follicular lymphoma
Additional relevant MeSH terms:
Neoplasms
Hemic and Lymphatic Diseases
Neoplasms by Histologic Type
Immune System Diseases
ClinicalTrials.gov processed this record on December 31, 2007 |
