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A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent 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 A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent Lymphoma Clinical research trials and A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent 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 A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent Lymphoma. A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent 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 A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent Lymphoma clinical trial. Test subjects typically receive the most expert healthcare available for their A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent 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 > "A" Clinical Trials Conditions > A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent Lymphoma  A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent Lymphoma
A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent Lymphoma
For Condition: Lymphoma, Follicular,Lymphoma, Small Lymphocytic
Status: No longer recruiting
Sponsor(s): Antigenics ,
Synopsis: Primary Objectives: - To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are: - the rate of complete and partial responses - the time to progression. Secondary Objectives: - To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks. - To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens. - To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient. - To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients with previously treated or newly diagnosed follicular center cell grade I or grade II lymphoma, small lymphocytic lymphoma, MALT lymphoma, monocytoid B-cell lymphoma, Waldenstrom’s macroglobulinemia, or marginal zone lymphoma with bidimensionally measurable disease; - Part of the resected specimen must undergo routine pathologic examination to confirm the diagnosis of lymphoma. The remaining tissue must be used for the preparation of autologous HSPPC-96; - Autologous HSPPC-96 vaccine must be successfully prepared and provided by the sponsor; - A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96 preparation; - Bidimensionally measurable disease in at least one location other than the resected lymphoid tissue; - Life expectancy of at least 16 weeks; - Zubrod performance status of less then or equal to 2; - Adequate bone marrow function; - Adequate hepatic function; - Adequate renal function; - Signed written informed consent; - Patients of child-bearing potential must practice contraception, which is adequate in the opinion of the Principal Investigator; - Patients of child-bearing potential must have a negative serum pregnancy test prior to entry into the study and must not be lactating; - Patients must be willing to be followed at the M. D. Anderson Cancer Center during the course of treatment and follow-up; - Electrocardiogram if none performed in the prior six months; - Patients must have no chemotherapy, immunotherapy, radiotherapy, or experimental anti-cancer therapy within six weeks prior to starting autologous HSPPC-96 administration; - Patients must have fully recovered from prior anti-cancer therapy; - Tumor measurements and staging no more than 4 weeks prior to receiving the first dose of autologous HSPPC-96. Exclusion Criteria: - Patients with active or prior history of central nervous system lymphoma; - Patients with serious intercurrent medical illnesses, requiring hospitalization; - Patients with a history of primary or secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on functional immune system) or patients taking immunosuppressive drugs such as systemic corticosteroids; - Women who are pregnant or lactating; - Patients participating in another clinical trial; - Patients receiving growth factors of any kind, including G-CSF, GM-CSF, or Epogen; - Patients with bulky disease, defined as greater than 10 cm in diameter; - Patients with positive HIV antibody; - Patients with more than 4 previous treatment regimens will be excluded.
Total Enrollment: 35
Location and Contact Information:
M.D. Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: C-100-09; MDACC Protocol ID99-354
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081809
Other Lymphoma, Small Lymphocytic Studies:
1. A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent Lymphoma
2. A Pilot Study of Pivanex in Patients with Chronic Lymphocytic Leukemia
3. Dose ranging trial for pixantrone in the FND-R variant regimen in indolent non-Hodgkin's lymphoma
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A Safety and Effectiveness Study of Vaccine Therapy in Patients with Indolent Lymphoma
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