Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Stage III or Stage IV Non-Hodgkin's Lymphoma
NCT ID: NCT00004198
Last Updated: 2023-12-27
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
1999-06-25
2003-11-20
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus sargramostim following chemotherapy in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.
Detailed Description
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OUTLINE: Patients receive induction chemotherapy consisting of oral cyclophosphamide, vincristine, and prednisone (CVP). Treatment repeats every 3 weeks until the maximal clinical response is achieved followed by 2 additional courses of consolidation therapy for up to a maximum of 10 courses. Patients not achieving adequate response receive up to 6 courses of alternate chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone. At 3 months or up to 1 year following completion of chemotherapy, patients achieving adequate disease response receive vaccination consisting of recombinant tumor derived immunoglobulin idiotype with keyhole limpet hemocyanin conjugate subcutaneously (SQ) at 2 sites immediately followed by sargramostim (GM-CSF) SQ on day 1. Patients receive GM-CSF alone on days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter until disease progression.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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keyhole limpet hemocyanin
sargramostim
tumor cell-based vaccine therapy
Eligibility Criteria
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Inclusion Criteria
* Follicular small cleaved cell
* Follicular mixed small cleaved and large cell with less than 50% large cells
* Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy
* Must have adequate circulating lymphoma cells
* Over 18 years old
* Karnofsky 80-100%
* WBC greater than 2,500/mm3
* Platelet count greater than 100,000/mm3
* Hemoglobin at least 10 g/dL
* Bilirubin less than 2 mg/dL
* SGOT/SGPT less than 2 times normal
* Creatinine less than 2 mg/dL
* HIV negative
* At least 2 months since prior non-physiologic doses of prednisone of greater than 20 mg or equivalent
Exclusion Criteria
* No CNS metastasis
* No other illness or condition, including innate or pharmacologic immunosuppression, that would preclude study
* No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* Not pregnant or nursing
* No prior biologic therapy for lymphoma
* No prior cytotoxic therapy for lymphoma
* No prior steroids for lymphoma
* No concurrent maintenance steroids or greater than 5 mg of daily prednisone or equivalent
* No prior radiotherapy for lymphoma A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Genitope Corporation
INDUSTRY
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Julie M. Vose, MD
Role: STUDY_CHAIR
University of Nebraska
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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Other Identifiers
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GENITOPE-9901
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0196-99-FB
Identifier Type: -
Identifier Source: org_study_id