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Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma Clinical research trials and Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma. Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma  Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma
Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma
For Condition: grade 3 follicular lymphoma,grade 1 follicular lymphoma,grade 2 follicular lymphoma
Status: Recruiting
Sponsor(s): Genitope ,
Synopsis: RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase II trial to study the effectiveness of rituximab followed by vaccine therapy and sargramostim in treating patients who have refractory or progressivenon-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the time to progression 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. - Determine the immune response rate in patients treated with these regimens. - Determine the safety and toxicity of these regimens in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive rituximab IV weekly for 4 weeks. - Group I: The first 20 patients to achieve a partial response (PR) or better receive autologous immunoglobulin idiotype-KLH conjugate vaccine (GTOP-99) 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 GTOP-99 and sargramostim SC as in group I beginning 13 weeks after the last dose of rituximab. In both 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. PROJECTED ACCRUAL: Approximately 60-140 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed follicular center cell non-Hodgkin's lymphoma - Stage III or IV disease at time of entry on Genitope study 2000-03 - At least 1 bidimensionally measurable lesion (1.5 cm X 1.5 cm) by radiography - Previously registered on and confirmed to be ineligible for randomization on Genitope study 2000-03 by failing to achieve or maintain a complete or partial response after chemotherapy by CT scans of the chest, abdomen, and pelvis (and neck if there was palpable disease) - Completed all 8 courses of chemotherapy (cyclophosphamide, vincristine, and prednisone [CVP]) per Genitope study 2000-03 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JuliaIwashita, Study Chair, Genitope
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Nancy Bartlett 314-362-6359
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Julie Vose 402-559-9053
Rush Cancer Institute at Rush University Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Stephanie Gregory 312-942-5689
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97201-3098
United States
Recruiting Craig Nichols 503-494-1080
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting John Leonard 212-746-0284
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5151
United States
Recruiting Ronald Levy 650-725-4968
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Ian Flinn 410-502-7985
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Kristen Ganjoo 317-278-4694
Additional Information:
Study ID Numbers: CDR0000269810; IUMC-0212-20,GENITOPE-2002-09
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071955
Other Grade 1 Follicular Lymphoma Studies:
1. Combination Chemotherapy With Monoclonal Antibody Therapy in Treating Patients With Newly Diagnosed Non-Hodgkin's Lymphoma
2. Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
3. Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma
4. Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
5. Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
Related Studies:
Other grade 1 follicular lymphoma Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's Lymphoma
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