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Idiotype vaccine for low-grade non-Hodgkin's lymphoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Idiotype vaccine for low-grade non-Hodgkin's lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Idiotype vaccine for low-grade non-Hodgkin's lymphoma Clinical research trials and Idiotype vaccine for low-grade non-Hodgkin's lymphoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Idiotype vaccine for low-grade non-Hodgkin's lymphoma. Idiotype vaccine for low-grade non-Hodgkin's lymphoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Idiotype vaccine for low-grade non-Hodgkin's lymphoma clinical trial. Test subjects typically receive the most expert healthcare available for their Idiotype vaccine for low-grade non-Hodgkin's lymphoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Idiotype vaccine for low-grade non-Hodgkin's lymphoma  Idiotype vaccine for low-grade non-Hodgkin's lymphoma
Idiotype vaccine for low-grade non-Hodgkin's lymphoma
For Condition: Lymphoma, Low-Grade
Status: No longer recruiting
Sponsor(s): Favrille ,
Synopsis: The purpose of this study was to determine if an idiotype vaccine, made from a patient's lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their tumor.
Details: The purpose of this study was to assess the ability of active immunotherapy to induce tumor regressions in relapsed low-grade lymphoma. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in the production of immunoglobulin idiotype. B-cell lymphomas arise from the clonal expansion of a single B-cell and all tumor cells express that unique Id protein. No normal B-cells possess that Id on their cell surface. Hence, Id protein should serve as an ideal target for individualized active immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak immunogens. To augment the immune response against Id, the Id protein must be chemically coupled to a strongly immunogenic protein. Keyhole limpet hemocyanin (KLH) is a commonly used protein carrier capable of augmenting the body's immune reaction against Id protein. While initial studies reported a predominately humoral (antibody) response, cellular immunity (T-cells) also plays a critical role in anti-tumor immunity. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - 18 years of age - Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification) - Patients that have responded with at least stable disease to their most recent chemo- or anti-CD20 antibody (Rituxan®, Zevalin, Bexxar) therapy for a minimum of 90 days and who currently have relapsed or who continue to have stable disease. - Tumor accessible for biopsy or previously existing biopsy material - At least 1 additional bidimensional lesion measuring at least 2 cm in each dimension - Performance status (ECOG) of 0, 1 or 2 - Absolute Granulocyte count ? 1,000/mm3 - Total Bilirubin < 2 mg/dL - AST and ALT < 2x Upper Limit of Normal - Creatinine < 1.5 mg/dL Exclusion Criteria - Patients who have had more than 3 prior chemotherapy or anti-CD20 regimens - Prior fludarabine - Prior tumor-specific idiotype immunotherapy - Patients whose disease has progressed within the first 90 days of their last chemotherapy or anti-CD20 treatment - Concurrent immunosuppressive therapy (high-dose steroids; etc) - Prior splenectomy - Surgery, cancer radiotherapy, steroid therapy, immunotherapy or chemotherapy within 90 days prior to first scheduled vaccination - Known history of CNS lymphoma or meningeal lymphomatosis - HIV positive - Serious non-malignant disease (e.g., psychiatric disorders, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives - Prior malignancy (excluding nonmelanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for > 2 years - Treatment with an investigational drug within 30 days prior to study entry - Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with FavId.
Total Enrollment: 22
Location and Contact Information:
Tower Hematology Oncology Medical Group
Los Angeles, California, 90048
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center
Bronx, New York, 10466
United States
University of Florida, Jacksonville
Jacksonville, Florida, 32209
United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45219
United States
Medical Group of North County
Vista, California, 92083
United States
University of California San Diego
La Jolla, California, 92093
United States
New York Hospital - Cornell Medical Center
New York City, New York, 10021
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Scripps Stevens Cancer Center
La Jolla, California, 92037
United States
Oncology Associates of San Diego
San Diego, California, 92123
United States
Northwestern University
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: FavId-01;
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036426
Other Lymphoma, Low-Grade Studies:
1. Campath-1H and Allogeneic Blood Stem Cell Transplantation for Lymphoid Malignancies
2. Phase II study of ONTAK in previously treated patients with low-grade Non-Hodgkin's Lymphoma (NHL)
3. Comparative trial for pixantrone in combination with rituximab in indolent non-Hodgkin's lymphoma
4. Dose ranging trial for pixantrone in the FND-R variant regimen in indolent non-Hodgkin's lymphoma
5. Idiotype vaccine for low-grade non-Hodgkin's lymphoma
Related Studies:
Other Lymphoma, Low-Grade Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Idiotype vaccine for low-grade non-Hodgkin's lymphoma
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