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Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines Clinical research trials and Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines. Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines clinical trial. Participants oftentimes recieve the finest healthcare available for their Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines  Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
For Condition: B Cell Lymphoma,Follicular Lymphoma,Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The idiotype of the immunoglobulin on a given B cell malignancy (Id) can serve as a clonal marker, and a previous pilot study in lymphoma patients has demonstrated that autologous Id protein can be formulated into an immunogenic, tumor specific antigen by conjugation to a carrier protein (KLH) and administration with an emulsion-based adjuvant. The goals of vaccine development in the current study are to develop vaccines: 1) with improved potency and 2) which are more effective at inducing cell-mediated immune responses. The selection of GM-CSF as the immunological "adjuvant" is a direct extension of our laboratory studies in small animal models demonstrating that GM-CSF can enhance the potency of the prototype Id-KLH vaccine by augmenting almost exclusively the cellular arm of the immune response. The objectives of this study are: 1) to evaluate cellular and humoral immune responses against the unique idiotype of the patient's lymphoma and 2) to evaluate the ability of the Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination or molecular examination (polymerase chain reaction amplification of the rearranged bcl-2 oncogene). The goal of this study is to treat previously untreated patients with follicular lymphomas to complete remission or minimal residual disease with ProMACE chemotherapy. Three to six months after completion of chemotherapy, in an effort to reduce the relapse rate (by eradicating microscopic disease resistant to chemotherapy), patients will receive an autologous Id vaccine administered in combination with GM-CSF. Id-KLH (0.5 mg) is administered subcutaneously. GM-CSF is administered subcutaneously locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination as close to the initial vaccination site as possible at one of two doses (patients are randomized to either a high or low dose, 500 or 100 micrograms/m2). We plan to accrue 42 patients. Twenty-nine patients have been enrolled. Sixteen patients have entered and/or completed the vaccination phase. Patients have demonstrated significant lymphoproliferative responses specific for autologous idiotype of a magnitude which is significantly greater than previously observed.
Details: The idiotype of the immunoglobulin on a given B cell malignancy (Id) can serve as a clonal marker, and a previous pilot study in lymphoma patients has demonstrated that autologous Id protein can be formulated into an immunogenic, tumor specific antigen by conjugation to a carrier protein (KLH) and administration with an emulsion-based adjuvant. The goals of vaccine development in the current study are to develop vaccines: 1) with improved potency and 2) which are more effective at inducing cell-mediated immune responses. The selection of GM-CSF as the immunological "adjuvant" is a direct extension of our laboratory studies in small animal models demonstrating that GM-CSF can enhance the potency of the prototype Id-KLH vaccine by augmenting almost exclusively the cellular arm of the immune response. The objectives of this study are: 1) to evaluate cellular and humoral immune responses against the unique idiotype of the patient's lymphoma and 2) to evaluate the ability of the Id vaccine to clear the bone marrow of malignant cells detectable by pathologic examination or molecular examination (polymerase chain reaction amplification of the rearranged bcl-2 oncogene). The goal of this study is to treat previously untreated patients with follicular lymphomas to complete remission or minimal residual disease with ProMACE chemotherapy. Three to six months after completion of chemotherapy, in an effort to reduce the relapse rate (by eradicating microscopic disease resistant to chemotherapy), patients will receive an autologous Id vaccine administered in combination with GM-CSF. Id-KLH (0.5 mg) is administered subcutaneously. GM-CSF is administered subcutaneously locally with the vaccine on the day of vaccination and for the three consecutive days following vaccination as close to the initial vaccination site as possible at one of two doses.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must meet all of the following eligibility criteria. Tissue diagnosis of: follicular small cleaved cell, or follicular mixed lymphoma with surface IgM, IgG or IgA phenotype with a monoclonal heavy and light chain. Pathology slides must be submitted to the NIH Pathology Department for review. Stage III or IV lymphoma. Only previously untreated patients are eligible. Previous treatment with radiation alone (less than TBI) is permissible. A single peripheral lymph node of at least 2 cm size accessible for biopsy/harvest. Karnofsky status greater than or equal to 70 percent. Life expectancy of greater than 1 year. Serum creatinine less than or equal to 1.5 mg per dl unless felt to be secondary to lymphoma. Bilirubin less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma or Gilbert's disease. SGOT/SGPT less than or equal to 3.5 times upper limit of normal. Ability to give informed consent. Ability to return to clinic for adequate follow-up for the period that the protocol requires. EXCLUSION CRITERIA: Prior total body irradiation. Presence of antibodies to HIV, hepatitis B surface antigen or other active infectious process. Pregnancy or lactation. Fertile men and women must plan to use effective contraception. A beta-HCG level will be obtained in women of child-bearing potential. Patients with previous or concomitant malignancy, regardless of site, except curatively treated squamous or basal cell carcinoma of the skin, or effectively treated carcinoma in situ of the cervix. Patients unwilling to give informed consent. Failure to meet any of the inclusion criteria. Any medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment will be excluded from this protocol. Patient with CNS lymphoma (current or previously treated) will not be eligible.
Total Enrollment: 43
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960133; 96-C-0133
Study Start Date: September 9, 1996
Record last reviewed: September 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001512
Other Follicular Lymphoma Studies:
1. Experimental Drug Mono-dgA-RFB4 to Treat B-Cell Lymphoma
2. A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma
3. Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
4. Cancer Vaccine for Lymphoma following Chemotherapy
5. Vaccination of Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype
Related Studies:
Other Follicular Lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Active Specific Immunotherapy for Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
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