Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
NCT ID: NCT00017290
Last Updated: 2013-12-04
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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UNKNOWN
PHASE3
INTERVENTIONAL
2000-11-30
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.
Detailed Description
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* Compare the time to tumor progression in patients with stage III or IV follicular B-cell non-Hodgkin's lymphoma treated with cyclophosphamide, prednisone, and vincristine followed by immunotherapy with keyhole limpet hemocyanin with or without autologous tumor-derived immunoglobulin idiotype and adjuvant sargramostim (GM-CSF).
* Compare the efficacy of these immunotherapy regimens in terms of converting patients with partial response or unconfirmed complete response to clinical complete response.
* Compare the safety and toxic effects of these immunotherapy regimens in this patient population.
* Compare the time to treatment failure and survival of patients treated with these regimens.
* Correlate the induction of idiotype-specific immune response with clinical benefits of achieving molecular remission in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
Patients receive cyclophosphamide IV over 30-40 minutes and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses.
At 6 months after completion of chemotherapy, patients maintaining partial response (PR), complete response (CR), or unconfirmed complete response (CRU) receive immunotherapy. Patients are stratified according to participating center and baseline disease status (PR vs CR/CRU). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive autologous tumor-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin (KLH) subcutaneously (SC) on day 1 and adjuvant sargramostim (GM-CSF) SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24.
* Arm II: Patients receive KLH alone SC on day 1 and GM-CSF SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20, and 24.
Quality of life is assessed prior to first immunization, at 2-8 weeks after completion of immunizations, and then every 6 months for 30 months.
Patients are followed every 3 months for 1 year and then every 6 months thereafter. Patients also enroll in a long-term follow-up study for an additional 5 years.
PROJECTED ACCRUAL: A total of 360 patients (240 in arm I and 120 in arm II) will be accrued from the 480 patients biopsied for this study within 15-18 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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autologous immunoglobulin idiotype-KLH conjugate vaccine
keyhole limpet hemocyanin
sargramostim
cyclophosphamide
prednisone
vincristine sulfate
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed stage III or IV follicular B-cell non-Hodgkin's lymphoma
* At least 1 bidimensionally measurable lesion by radiography, in addition to lesion removed for biopsy
* No clinical evidence of CNS involvement
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative
Renal:
* Creatinine less than 1.5 times ULN
Other:
* No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No history of autoimmune disease
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior antibody therapy for lymphoma
Chemotherapy:
* No prior cytotoxic therapy for lymphoma
Endocrine therapy:
* No prior corticosteroids for lymphoma
* At least 12 months since prior corticosteroids or immunosuppressants for other conditions
* Prior transient corticosteroids (prior to CT imaging) or optical solutions allowed
Radiotherapy:
* Prior radiotherapy for lymphoma (no more than 2 sites of limited disease) allowed
Surgery:
* See Disease Characteristics
Other:
* No concurrent participation in other therapeutic clinical trial
18 Years
ALL
No
Sponsors
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Genitope Corporation
INDUSTRY
Principal Investigators
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David Hinds
Role: STUDY_CHAIR
Genitope Corporation
Locations
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SuperGen, Incorporated
Dublin, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, United States
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States
Mountain States Tumor Institute - Boise
Boise, Idaho, United States
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
Countries
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References
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Levy R, Ganjoo KN, Leonard JP, Vose JM, Flinn IW, Ambinder RF, Connors JM, Berinstein NL, Belch AR, Bartlett NL, Nichols C, Emmanouilides CE, Timmerman JM, Gregory SA, Link BK, Inwards DJ, Freedman AS, Matous JV, Robertson MJ, Kunkel LA, Ingolia DE, Gentles AJ, Liu CL, Tibshirani R, Alizadeh AA, Denney DW Jr. Active idiotypic vaccination versus control immunotherapy for follicular lymphoma. J Clin Oncol. 2014 Jun 10;32(17):1797-803. doi: 10.1200/JCO.2012.43.9273. Epub 2014 May 5.
Other Identifiers
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GENITOPE-G2000-03
Identifier Type: -
Identifier Source: secondary_id
CUMC-0101-142
Identifier Type: -
Identifier Source: secondary_id
UCLA-0010061
Identifier Type: -
Identifier Source: secondary_id
CDR0000068673
Identifier Type: -
Identifier Source: org_study_id