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Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma Clinical research trials and Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma. Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma  Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
For Condition: stage 4 grade II follicular mixed cell lymphoma,stage 3 grade I follicular small cleaved cell lymphoma,stage 3 grade II follicular mixed cell lymphoma,stage 4 grade I follicular small cleaved cell lymphoma
Status: No longer recruiting
Sponsor(s): University of Nebraska ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill tumor cells. Sargramostim may stimulate a person's immune system and help to kill tumor cells. 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.
Details: OBJECTIVES: I. Determine the ability of recombinant idiotype immunotherapy to stimulate a specific immune response against the B cell idiotype of the malignant clone that constitutes the tumor in patients with previously untreated stage III or IV indolent non-Hodgkin's lymphoma. II. Determine the safety and toxicity of this treatment regimen using Genitope Corporation's molecular rescue technology in this patient population. PROTOCOL 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. PROJECTED ACCRUAL: Not specified
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage III or IV, indolent non-Hodgkin's lymphoma; Follicular small cleaved cell; Follicular mixed small cleaved and large cell with less than 50% large cells - No intermediate, high grade, or other non-Hodgkin's lymphomas (e.g., mantle cell, monocytoid B cell, marginal zone, small lymphocytic, chronic lymphocytic leukemia, or follicular large cell) - Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy; Must have adequate circulating lymphoma cells - No CNS metastasis [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.] --Prior/Concurrent Therapy-- - Biologic: No prior biologic therapy for lymphoma - Chemotherapy: No prior cytotoxic therapy for lymphoma - Endocrine: No prior steroids for lymphoma; At least 2 months since prior nonphysiologic doses of prednisone of greater than 20 mg or equivalent; No concurrent maintenance steroids or greater than 5 mg of daily prednisone or equivalent - Radiotherapy: No prior radiotherapy for lymphoma - Surgery: Not specified --Patient Characteristics-- - Age: Over 18 - Performance status: Karnofsky 80-100% - Life expectancy: Not specified - Hematopoietic: WBC greater than 2,500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin less than 2 mg/dL; SGOT/SGPT less than 2 times normal - Renal: Creatinine less than 2 mg/dL - Other: 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; HIV negative; Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JulieVose, Study Chair, University of Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Additional Information:
Study ID Numbers: CDR0000067441; UNMC-196-99,GENITOPE-9901
Study Start Date: June 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004198
Other Stage 4 Grade I Follicular Small Cleaved Cell Lymphoma Studies:
1. Interferon alfa-2b in Treating Patients With Advanced Low-Grade Non-Hodgkin's Lymphoma
2. Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
3. Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma
4. Rituximab in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
5. Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma
Related Studies:
Other stage 4 grade I follicular small cleaved cell lymphoma Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
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