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Siplizumab in Treating Patients With Lymphoproliferative Disorder Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Siplizumab in Treating Patients With Lymphoproliferative Disorder conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Siplizumab in Treating Patients With Lymphoproliferative Disorder Clinical research trials and Siplizumab in Treating Patients With Lymphoproliferative Disorder healthcare trials occur in a lot of of places across 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 effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Siplizumab in Treating Patients With Lymphoproliferative Disorder. Siplizumab in Treating Patients With Lymphoproliferative Disorder Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Siplizumab in Treating Patients With Lymphoproliferative Disorder clinical trial. Test subjects typically receive the most effective healthcare possible for their Siplizumab in Treating Patients With Lymphoproliferative Disorder condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Siplizumab in Treating Patients With Lymphoproliferative Disorder  Siplizumab in Treating Patients With Lymphoproliferative Disorder
Siplizumab in Treating Patients With Lymphoproliferative Disorder
For Condition: Lymphoma,angiocentric immunoproliferative lesions,Leukemia
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Monoclonal antibodies such as siplizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of siplizumab in treating patients who have lymphoproliferative disorder.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of siplizumab (MEDI-507) in patients with CD2-positive lymphoproliferative disorders. - Determine the safety and tolerability of this drug in these patients. Secondary - Determine the time to MEDI-507 saturation of CD2-binding sites in peripheral blood and tumor aspirates of these patients. - Determine the serum pharmacokinetics of this drug in these patients. - Determine the time to T-cell and natural killer cell depletion and recovery in patients after treatment with this drug. - Determine the antitumor activity of this drug, in terms of response rate, time to progression, and overall survival, in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive siplizumab (MEDI-507) IV over 2-6 hours on days 1 and 2 OR on days 1-3. Treatment repeats every 2 weeks for a total of 16 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MEDI-507 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 30 days and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 3-42 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 lymphoproliferative disorder, including the following types: - Adult T-cell leukemia - No smoldering leukemia - Cutaneous T-cell lymphoma - All stages, excluding stage Ia - Patients with stage Ib, II, or III disease must have failed at least 1 prior standard therapy regimen - Peripheral T-cell lymphoma - Stage I-IV - Disease progression after standard chemotherapy - Large granular lymphocyte leukemia meeting the following criteria: - Must have 1 of the following: - Myelosuppression based on at least 1 of the following laboratory values: - Granulocyte count no greater than 1,500/mm^3 - Platelet count no greater than 75,000/mm^3 - Hemoglobin no greater than 10 g/dL - Requirement for hematopoietic support (e.g., transfusion or colony-stimulating factors, including filgrastim [G-CSF], interleukin-11, or epoetin alfa) to maintain blood levels or control systemic symptoms (e.g., fever, night sweats, or weight loss) - Disease unresponsive to 1 prior therapy regimen - Monoclonal and polyclonal forms of disease allowed - CD2-positive by immunohistochemistry - At least 30% of tumor cells must express CD2 - Measurable or evaluable disease - No history of CNS disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - More than 2 months Hematopoietic - See Disease Characteristics - Granulocyte count at least 1,000/mm^3* - Platelet count at least 50,000/mm^3* NOTE: *Requirement waived for patients with large granular lymphocyte leukemia Hepatic - SGOT and SGPT no greater than 2.0 times upper limit of normal - Bilirubin no greater than 2.0 mg/dL - Hepatitis B surface antigen negative - No positive antibodies to hepatitis C virus Renal - Creatinine less than 1.5 mg/dL Cardiovascular - No myocardial infarction within the past 6 months - No uncontrolled hypertension within the past 6 months - No stroke or transient ischemic attack within the past 6 months Pulmonary - Oxygen saturation level at least 90% by pulse oximetry - No respiratory insufficiency requiring oxygen therapy Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No positive antigenemia test for cytomegalovirus - No history of significant adverse events related to previously administered monoclonal antibody - No active infection requiring systemic anti-infective therapy - No physical or general medical illness that would increase risk to the patient - No psychological or behavioral condition that would increase risk to the patient or preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - At least 30 days since prior gamma globulin - At least 30 days since prior monoclonal antibody therapy - No prior siplizumab (MEDI-507) - No other concurrent monoclonal antibody therapies - No other concurrent biologic response modifier therapy - No concurrent gamma globulin - Concurrent G-CSF, epoetin alfa, and interleukin-11 allowed for large granular lymphocyte leukemia Chemotherapy - See Disease Characteristics - At least 3 weeks since prior cytotoxic chemotherapy and recovered - No concurrent FDA-approved or investigational cancer chemotherapeutic agents Endocrine therapy - At least 3 weeks since prior steroids and recovered - No concurrent steroids Radiotherapy - Not specified Surgery - At least 3 weeks since prior surgery and recovered Other - At least 30 days since other prior investigational anticancer drugs - No other concurrent investigational anticancer drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnJanik, Principal Investigator, Metabolism Branch
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitement 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000344422; NCI-04-C-0031,MEDIMMUNE-MI-CP094
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075361
Other Angiocentric Immunoproliferative Lesions Studies:
1. Investigating Voriconazole to Prevent Systemic Fungal Infection
2. Radiation Therapy and Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With High-Grade Lymphoma or Acute Lymphoblastic Leukemia
3. UCN-01 and Fludarabine to Treat Lymphoma and Leukemia
4. Flavopiridol in Treating Patients With Refractory Cancer
5. Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
Related Studies:
Other angiocentric immunoproliferative lesions Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Siplizumab in Treating Patients With Lymphoproliferative Disorder
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