Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma
NCT ID: NCT00071955
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2003-03-31
2009-01-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of rituximab followed by vaccine therapy and sargramostim in treating patients who have refractory or progressive non-Hodgkin's lymphoma.
Detailed Description
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* Determine progression-free survival in patients with refractory or progressive follicular non-Hodgkin's lymphoma treated with immediate or delayed autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim after rituximab (groups I and II).
* Determine the immune response rate in patients treated with these regimens (groups I, II, and III).
* Determine the safety and toxicity of these regimens in these patients (groups I, II, and III).
OUTLINE: This is an open-label, multicenter study for patients previously registered on and confirmed ineligible for randomization in protocol Genitope-G2000-03.
Patients receive rituximab IV weekly for 4 weeks.
* Group I: The first 30 patients to achieve and maintain a partial response (PR) or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously (SC) on day 1 and sargramostim SC on days 1-4 beginning 26 weeks after the last dose of rituximab. Treatment repeats every 2 weeks for 14 weeks (8 immunizations).
* Group II: All subsequent patients who achieve a PR or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC as in group I beginning 13 weeks after the last dose of rituximab.
* Group III: Patients who are not eligible for group I or II and, in the investigator's opinion, are suitable candidates for immunization with autologous immunoglobulin idiotype-KLH conjugate vaccine and sargramostim SC receive the same treatment as groups I and II, beginning no more than 1 year after the last (fourth) dose of rituximab.
In all groups, treatment continues in the absence of unacceptable toxicity or emergence of an illness that may interfere with study assessments.
Patients are followed for initial response 8 weeks after completion of immunizations and then every 12 weeks for an additional year. Thereafter, all immunized patients will be followed every 6 months until receipt of first subsequent anti-lymphoma therapy.
PROJECTED ACCRUAL: Up to 120 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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autologous immunoglobulin idiotype-KLH conjugate vaccine
sargramostim
Eligibility Criteria
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Inclusion Criteria
* No intervening therapy for lymphoma (i.e., antibody, corticosteroids, or cytotoxic) between CVP and study entry
* No evidence of transformation (e.g., rapid tumor growth or increasing lactic dehydrogenase)
* No CNS involvement
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after the last immunization series
* HIV negative
* No history of autoimmune disease or conditions requiring treatment with immunosuppressive agents, including corticosteroids
* No other malignancy within the past 2 years except non-basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* See Disease Characteristics
* At least 6 months since prior corticosteroids, including topical administration for any concurrent disease
* No concurrent chronic (more than twice monthly) corticosteroids (including topical or inhaled)
* Transient use (prior to CT scan) or optical solutions allowed
Radiotherapy
* Prior radiotherapy to no more than 2 sites more than 13 weeks before rituximab is allowed
Surgery
* Not specified
Other
* No concurrent participation in other therapeutic clinical trials
18 Years
ALL
No
Sponsors
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Genitope Corporation
INDUSTRY
Principal Investigators
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Martha Mayo, PharmD
Role: STUDY_CHAIR
Genitope Corporation
Locations
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Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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Timmerman JM, Vose JM, Czerwinski DK, Weng WK, Ingolia D, Mayo M, Denney DW, Levy R. Tumor-specific recombinant idiotype immunisation after chemotherapy as initial treatment for follicular non-Hodgkin lymphoma. Leuk Lymphoma. 2009 Jan;50(1):37-46. doi: 10.1080/10428190802563355.
Other Identifiers
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GENITOPE-2002-09
Identifier Type: -
Identifier Source: secondary_id
IUMC-0212-20
Identifier Type: -
Identifier Source: secondary_id
CDR0000269810
Identifier Type: -
Identifier Source: org_study_id