- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00017290
Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy, Recombinant Idiotype Conjugated To KLH With GM-CSF, Compared To Non-Specific Immunotherapy, KLH With GM-CSF, In Patients With Follicular Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma.
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- 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.
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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California
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Dublin, California, United States, 94568
- SuperGen, Incorporated
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Greenbrae, California, United States, 94904
- California Cancer Care, Inc.
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Stanford, California, United States, 94305-5151
- Stanford Cancer Center at Stanford University Medical Center
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Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers - Midtown
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Florida
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Gainesville, Florida, United States, 32610-0277
- Shands Cancer Center at the University of Florida Health Science Center
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Idaho
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Boise, Idaho, United States, 83712
- Mountain States Tumor Institute - Boise
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Cancer Institute at Rush University Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Cancer Center
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Maryland
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Baltimore, Maryland, United States, 21231
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Baltimore, Maryland, United States, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109-0942
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, United States, 48105-2399
- Veterans Affairs Medical Center - Ann Arbor
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Nebraska
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Omaha, Nebraska, United States, 68198-7680
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Cancer Center at Hackensack University Medical Center
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New York
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New York, New York, United States, 10021
- New York Weill Cornell Cancer Center at Cornell University
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Ohio
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Oregon
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Portland, Oregon, United States, 97201-3098
- Cancer Institute at Oregon Health and Science University
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Tennessee
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Cancer Center at Centennial Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: David Hinds, Genitope Corporation
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Adjuvants, Immunologic
- Cyclophosphamide
- Antibodies
- Immunoglobulins
- Immunoglobulins, Intravenous
- Immunoglobulin Idiotypes
- Prednisone
- Vincristine
- Sargramostim
- Keyhole-limpet hemocyanin
Other Study ID Numbers
- CDR0000068673
- GENITOPE-G2000-03
- CUMC-0101-142
- UCLA-0010061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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