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Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA Clinical research trials and Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA. Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA clinical trial. Participants typically obtain the most effective healthcare available for their Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA  Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA
Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA
For Condition: T Cell Leukemia
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a dose-finding study to estimate the maximum tolerated dose (MTD) of yttrium-90-labeled humanized monoclonal antibody anti-Tac (90Y-MOAB anti-Tac). All patients receive intravenous 90Y-MOAB anti-Tac once every 6 weeks with a fixed dose of calcium-DTPA given for 3 days; the quantity of anti-Tac protein administered is determined by individual serum interleukin-2 receptor levels. Groups of 3-6 patients receive escalated doses of yttrium-90 until the MTD is determined. Additional patients are treated at the MTD. Patients without evidence of disease progression or circulating antibodies to humanized anti-Tac may receive up to 8 further treatments that are at least 6 weeks apart and at least 1 week after the cessation of G-CSF therapy (if given to increase neutrophil count). Patients are followed 4-6 weeks after the therapy is completed.
Details: The purpose of the study is to determine (1) the maximum tolerated dose of humanized-anti-Tac monoclonal antibody conjugated with Yttrium-90 (90Y) and (2) the clinical response in patients with Tac-expressing adult T-cell leukemia (ATL). This study represents an extension of Metabolism Branch, NCI protocols utilizing modifications of the anti-Tac monoclonal antibody in the treatment of ATL. The scientific basis for these therapeutic studies is that the leukemic cells of patients with ATL express abnormally high levels of the Tac antigen (the IL-2Ralpha) on their surfaces whereas resting normal cells including T cells, do not. The administration of unconjugated murine and humanized anti-Tac to patients with Tac-expressing malignancies is permitted under Protocol #83-C-0023 and #90-C-0075 respectively. The use of murine anti-Tac conjugated with 111In for scanning and conjugated with 90Y for therapy in patients with ATL is permitted under Protocols # 87-C-0003 and #90-C-0043B respectively. The maximum tolerated dose in the Phase I trial of 90Y-murine anti-Tac (90Y-MAT) was 10 mCi. In 1993 a phase II study of Yttrium-90 (90Y)-labeled humanized-anti-Tac (90Y-HAT) protocol #93-C-0066 was initiated. In that trial all patients received an initial dose of 10 mCi of 90Y-HAT followed by up to 8 successive doses of 5 mCi. A review of the results of the first 15 patients treated has shown evidence of both less efficacy and less toxicity than seen in the 90Y-murine anti-Tac study. Also, recent data from another group has indicated that the maximum tolerated dose of the 90Yttrium can be significantly increased through use of an intravenous chelate, calcium DTPA (Ca-DTPA). As a result we propose a Phase I/II, dose escalation trial of 90Yttrium labeled humanized anti-Tac with a fixed dose of calcium-DTPA for the treatment of patients with Tac-expressing ATL. We will administer Ca-DTPA intravenously to facilitate urinary excretion of 90Y and thereby reduce toxicity. There will be two phases to the study, a phase I dose escalation element to define the maximum tolerated dose and a phase II element at the dose of 90Y-anti-Tac defined in the first element. Eligible patients will be treated at the Clinical Center of the NIH. Clinical response will be evaluated using routine hematological and clinical evaluation and by monitoring the malignant cell phenotype using antibodies to the interleukin-2 receptor. Furthermore, we plan to monitor the serum levels of the released form of the Tac-peptide (sIL-2R), and to monitor the levels of antibodies produced by the patients that are directed toward the infused humanized anti-Tac.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: All patients must have a histologically confirmed diagnosis of adult T-cell leukemia/ lymphoma. At least 10% of each patient's of peripheral blood, lymph node, or dermal malignant cells react with anti-Tac, as determined by immunofluorescent staining, or soluble IL-2 receptor levels must be greater than 1,000 units/ml (normal geometric mean, 235; 95% confidence levels 112 to 502 units/ml). All stages of Tac-expressing adult T-cell leukemia are eligible. Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat. To be diagnosed as smoldering ATL, the patient must have a normal lymphocyte count (less than 4 X 10(3)/mm(3)), greater than or equal to 5% abnormal lymphocyte on morphologic examination of the peripheral blood smear, no hypercalcemia, lactate dehydrogenase less than or equal to 1.5 times the upper limit of normal, no lymphadenopathy, no involvement of extranodal organs except skin or lung and no malignant pleura effusion or ascites. If the abnormal lymphocyte count is less than 5%, the patient should have at least one histologically-proven skin or pulmonary lesion to be diagnosed as smoldering ATL. All patients must have measurable disease. Patients with greater than 10% abnormal (i.e., Tac-strongly expressing) cells in the peripheral blood will be deemed to have measureable disease. The patient must have a granulocyte count of at least 1,000/mm(3) and a platelet count of 75,000/mm(3). Patients must have a creatinine of less than 1.5 mg/dl. If the patient has an abnormally elevated creatinine a creatinine clearance must be greater than 35 ml/min. Patients must be able to understand and sign informed consent. ATL patients without, as well as those with, previous chemotherapy will be eligible for inclusion in the study. Omission of cytotoxic chemotherapy for ATL is required for 4 weeks prior to entry into the trial. However, patients receiving corticosteroids will not be excluded. Patients must have a life expectancy of greater than 2 month. Patients must be at least 18 years old. Patients must have SGOT and SGPT less than 2.5 times the upper limit of normal, bilirubin less than 2.0 unless this is felt to be due to ATL. If a liver functions study is judged to be elevated due to the underlying ATL this parameter we be considered an unevaluable parameter for toxicity determinations. Patient must not have clinical cardiac failure. Patients with symptomatic pulmonary dysfunction are eligible only if it is due to the underlying malignancy. EXCLUSION CRITERIA: Patient with symptomatic central nervous system disease that is due to the adult T-cell leukemia will be excluded. However, patients that have both ATL and another HTLV-I-associated disease, tropical spastic paraparesis (TSP), will be included. Patients with neurologic signs or symptoms (e.g. altered mental status, cranial nerve palsies, leg weakness, bowel or bladder dysfunction) that are not known to be due to some other diagnosis and could be indicative of CNS involvement by leukemia will receive a lumbar puncture prior to treatment. Female patients of child-bearing potential will be tested for pregnancy; pregnant patients will be excluded from the study. Breast-feeding females are not eligible for the study. HIV positive patients are excluded from the study. Patients with detectable levels of greater than 250 ng/ml of antibody to the infused monoclonal antibody in the serum as assessed by an ELISA procedure will be excluded from the study.
Total Enrollment: 45
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960147; 96-C-0147
Study Start Date: September 27, 1996
Record last reviewed: June 27, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001514
Other T Cell Leukemia Studies:
1. Phase I Study of T-Cell Large Granular Lymphocytic Leukemia Using the MIK-Beta-1 Monoclonal Antibody Directed Toward the IL-2R-Beta Subunit
2. Phase I Study of Anti-Tac(Fv)-PE38 (LMB-2), a Recombinant Single-Chain Immunotoxin for Treatment of Tac-Expressing Malignancies
3. Anti-Tac for Treatment of Leukemia
4. Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA
Related Studies:
Other T Cell Leukemia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I/II Study of Tac-Expressing Adult T-Cell Leukemia (ATL) with Yttrium-90 (90Y)-Radiolabeled Humanized Anti-Tac Monoclonal Antibody and Calcium-DTPA
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