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Home > "P" Clinical Trials Conditions > Phase I Trial of MEDI-507 in CD2-Positive Lymphoproliferative Disease  Phase I Trial of MEDI-507 in CD2-Positive Lymphoproliferative Disease
Phase I Trial of MEDI-507 in CD2-Positive Lymphoproliferative Disease
For Condition: Lymphoproliferative Disorders
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the maximum tolerated dose of MEDI-507 given to patients with CD2-positive lymphoproliferative disorders and determine the safety and tolerability of MEDI-507 among those patients. Lymphoproliferative disorders, such as leukemia and lymphoma, are those in which a large number of white blood cells are stored in the lymph nodes and spleen. Monoclonal antibodies, that is, antibodies made in a laboratory from an animal antibody so that they are quite similar to human ones, have become an important addition to surgery, radiation, and chemotherapy for treating patients with cancer. The form of cancer pertaining to this study is one that affects the T-cells-infection-fighting cells. Most cancers that affect the T-cells have a protein on the surface of the cell called CD2. The antibody MEDI-507 targets CD2 and attaches itself. Patients 18 years of age and older with a confirmed diagnosis of a lymphoproliferative disorder and whose cancer has continued to grow despite previous treatment with chemotherapy, radiation, or antibodies may be eligible for this study. Participants will enter one of seven dose groups. The dose depends on a patient's body weight at the time he or she enters the study. Each group of patients will receive higher doses of MEDI-507 than the previous group as long as MEDI-507 is safe and tolerated well. The first group will receive a dose of 0.2 mg/kg per day on 2 consecutive days each treatment week, every other week for 16 weeks. If MEDI-507 appears safe and is tolerated well after 2 weeks, then the next group will receive the same dose of MEDI-507 but for 3 consecutive days each treatment week, every other week for 16 weeks. Subsequent groups will receive higher doses. Patients will stay in the hospital Monday to Friday, during the time they are receiving MEDI-507. Patients will undergo the following tests and procedures: -Blood test for complete blood count and chemistries. -Blood test for hepatitis B and C virus, HIV, and cytomegalovirus, that is, a herpesvirus. -Urinalysis. -Chest X-ray. -Vital signs. -Temperature. -Assessment of adverse effects. In addition, patients who are receiving lower doses of MEDI-507 who do not have a severe side effect may be allowed to receive the next higher dose-that is, if their lymphocyte counts do not decrease by 50% from baseline after the second treatment week and if it seems safe to receive higher doses. During the study, patients may also receive blood transfusions to maintain proper levels of blood cells and platelets and may receive filgrastim, a stimulator of bone marrow cells if the white blood cell count gets too low. There will be follow-up. Patients will be asked to return 30 days after the last dose of the drug and then every 3 months for 1 year-and may have the option to enter a long-term follow-up study.
Details: The primary objective of this study is to determine the maximum tolerated dose (MTD) and safety and tolerability of MEDI-507 in patients with CD2-positive lymphoproliferative disorders. Seven cohorts of 3 patients each will receive escalating intravenous doses of MEDI-507 ranging from 0.2 to 2.6 mg/kg per treatment day and 0.4 to 4.8 mg/kg per treatment week. Patients will receive MEDI-507 for 2 or 3 consecutive days each treatment week as inpatients, every other week for 16 weeks at the following doses: Cohort 1 (0.2 and 0.2 mg/kg); Cohort 2 (0.2, 0.2, and 0.2 mg/kg); Cohort 3 (0.4 and 0.4 mg/kg); Cohort 4 (0.4, 0.4, and 0.4 mg/kg); Cohort 5 (0.4, 0.8, and 1.2 mg/kg); Cohort 6 (0.4, 1.2, and 1.8 mg/kg); and Cohort 7 (0.4, 1.8, and 2.6 mg/kg). Patients in Cohorts 1 and 3 will receive MEDI-507 on 2 consecutive days each treatment week. Patients in the remaining cohorts will receive MEDI-507 on 3 consecutive days each treatment week. MEDI-507 will be administered until unacceptable toxicity, documentation of disease progression, or other reasons for patient withdrawal, whichever comes first. Patients may be entered in the next higher dose cohort if the patients treated in the preceding dose cohort have completed 2 treatment weeks and 1 week of follow-up after the second week of treatment without a dose-limiting toxicity (DLT). If 1 of 3 patients experiences a DLT, 3 additional patients will be entered in that dose cohort. If no additional DLTs occur, then patients may be entered in the next higher dose cohort. If 2 of 3 or 2 of 6 patients experience a DLT, the MTD will be exceeded and the preceding dose cohort will be the MTD. This study will also evaluate the serum pharmacokinetics of MEDI-507 and determine the dose of MEDI-507 required to saturate CD2-binding sites (Cohorts 3 through 7) in tumor aspirates and in peripheral blood. This study will assess the clinical tumor response in a preliminary fashion in a variety of CD2-positive lymphoproliferative disorders. This study represents an extension of the Metabolism Branch basic research efforts towards understanding the mechanism of antitumor activity of monoclonal antibodies in general and specifically antibodies to CD2. In this Phase I study, a limited course of MEDI-507 therapy will be evaluated as prolonged therapy may be associated with unacceptable immunosuppression secondary to depletion of normal T-cells that express CD2.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must meet all of the following criteria at the time of enrollment. 1. Men or women at least 18 years of age. Women of childbearing potential must have a negative serum pregnancy test within 72 hours of study drug administration. Women of childbearing potential must agree to practice an effective method of contraception. Sexually active males must agree to use a condom. 2. Histologically confirmed diagnosis of a lymphoproliferative disorder as determined by the Laboratory of Pathology at the Clinical Center at the National Institutes of Health (NIH). Only patients with the following lymphoproliferative disorders listed will be eligible. a. ATL: Patients with all except the smoldering form of ATL will be eligible, regardless of whether they have had previous therapy since there is no effective standard of care therapy for this disease. b. CTCL: Patients with all stages of cutaneous T-cell lymphoma (CTCL) are eligible with the exception of Stage Ia. Patients with Stages Ib through III are eligible if their disease has failed at least one standard form of prior therapy. c. PTCL: Patients with Stages I-IV peripheral T-cell lymphoma (PTCL) are eligible if their disease has progressed after standard chemotherapy. d. LGL: Patients with large granular lymphocyte leukemia must have myelosuppression (granulocyte count less than or equal to1,500/microL, platelet count less than or equal 75,000/microL, or hemoglobin less than or equal 10 g/dL), or require hematopoietic support (transfusion or colony stimulating factors including filgrastim, IL-11, or erythropoietin) to maintain counts at these or higher levels or systemic symptoms (fever, night sweats or weight loss). Patients must have disease that is unresponsive to one prior therapy. Patients with monoclonal and polyclonal forms of the disease will be eligible. 3. Cells must express CD2. CD2 expression will be verified by immunohistochemistry in the Laboratory of Pathology at the NIH. At least 30% of tumor cells must be CD2 positive for the patient to be eligible for the study by immunohistochemistry. CD2 staining will be performed on existing tissue blocks and on fresh tumor tissue if a biopsy is performed. It is expected that the majority of patients will have CD2 expression evaluated by flow cytometry and the majority of cells will express the marker. 4. Measurable or evaluable disease. 5. Karnofsky Performance Status greater than or equal to 70%. 6. Life expectancy of greater than 2 months. 7. Granulocyte count greater than or equal to 1,000/mm3 and a platelet count greater than or equal to 50,000/mm3. Patients with LGL leukemia are excluded from these criteria. For patients with LGL leukemia, ANC and platelet count will not be considered in determining study eligibility. 8. Serum creatinine less than 1.5 mg/dL. 9. Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) value less than or equal to 2.0-fold greater than the upper limit of normal and bilirubin less than or equal to 2.0 mg/dL. 10. Prior treatment with cytotoxic chemotherapy, surgery, and steroids is allowed provided last treatment was given at least 3 weeks prior to first dose of study drug administration and all toxicities have resolved. 11. Prior treatment with other investigational anticancer drugs, monoclonal antibodies, and gammaglobulin is allowed provided last treatment was given at least 30 days prior to first dose of study drug administration. 12. Patients must understand and sign an NCI pre-screening consent form and a protocol specific informed consent form prior to receipt of any study medication or beginning study procedures. EXCLUSION CRITERIA: Patients must have none of the following at the time of enrollment. 1. Known history of central nervous system (CNS) disease. 2. Pregnant and nursing. The effects of MEDI-507 on the developing fetus and the nursing infant are unknown. 3. Positive for human immunodeficiency virus (HIV) because of the risk of increased HIV-associated complications due to increased immunosuppression. 4. Positive for hepatitis B surface antigen or with antibodies to hepatitis C virus because the therapy may be associated with increased viral replication. 5. Positive antigenemia test for cytomegalovirus (CMV) 6. Prior treatment with MEDI-507. 7. Prior history of significant adverse events related to previously administered monoclonal antibody. 8. History within 6 months prior to first dose of study drug administration or evidence of intercurrent illnesses including myocardial infarction, uncontrolled hypertension, stroke, or transient ischemic attacks. 9. Respiratory insufficiency requiring oxygen therapy or O2 saturation less than 90% by pulse oximetry. 10. Active infection requiring systemic anti-infective therapy or other physical or psychological illnesses that would increase risk to the patient in the opinion of the Principal Investigator. 11. Any general medical or psychological or behavioral conditions that in the opinion of the investigator may pose additional risk in administering study drug to the patient or will not permit the patient to complete the study or sign informed consent.
Total Enrollment: 42
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 040031; 04-C-0031
Study Start Date: October 31, 2003
Record last reviewed: October 28, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071825
Other Lymphoproliferative Disorders Studies:
1. Stem Cell Transplant for Patients with Blood Malignancy Using Donors and Less Toxic Chemotherapy with CAMPATH 1H
2. Phase I Trial of MEDI-507 in CD2-Positive Lymphoproliferative Disease
3. Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) to Evaluate Autoimmune Lymphoproliferative Syndrome (ALPS) and ALPS-associated Lymphoma
4. A Pilot Study of the Combination of Retinoic Acid and Interferon-Alpha2a for the Treatment of Lymphoproliferative Disorders in Children with Immunodeficiency Syndromes
5. Prevention and Treatment of Epstein-Barr Virus (EBV) Lymphoma Following a Solid Organ Transplant Using EBV Specific Cytotoxic T Lymphocytes (CTLs).
Related Studies:
Other Lymphoproliferative Disorders Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase I Trial of MEDI-507 in CD2-Positive Lymphoproliferative Disease
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