|
Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas 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 Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas Clinical research trials and Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas 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 Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas. Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas 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 Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas clinical trial. Test subjects typically receive the most expert healthcare available for their Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas 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.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas  Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas
Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas
For Condition: Lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the safety and effectiveness of combination therapy with the monoclonal antibody Campath-1H and continuous infusion of a chemotherapy regimen called EPOCH for treating non-Hodgkin's T-cell and NK-cell lymphomas. In general, T-cell and NK-cell lymphomas are less responsive to standard treatments than B-cell lymphomas. EPOCH, which includes the drugs doxorubicin, etoposide, vincristine, cyclophosphamide, and prednisone, has shown a high degree of effectiveness in patients whose tumors have stopped responding to standard regimens. Campath-1H may improve the effects of chemotherapy. Patients 17 years of age and older with T- or NK-cell non-Hodgkin's lymphoma whose disease is considered to be more amenable to chemotherapy than surgery or radiation may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, and electrocardiogram. Other tests that may be required include: lumbar puncture (spinal tap); imaging tests such as magnetic resonance imaging (MRI), positron emission tomography (PET), computed tomography (CT), and x-rays; and biopsy (surgical removal of a small tissue sample) of tumor, bone marrow, or other tissue. Patients receive treatment in chemotherapy cycles that are repeated every 3 weeks. Drugs are administered during the first 5 days of the cycle, followed by 16 days of rest. The cycles are repeated until the tumor disappears (goes into remission) or shows no further signs of shrinking: - Campath-1H, given by vein over about 12 hours on the first day of therapy, immediately before the chemotherapy infusion begins. - Doxorubicin, etoposide, and vincristine, given by continuous IV infusion over 4 days, beginning on day 1 and ending on day 5 of each cycle. The drugs are delivered through a lightweight portable infusion pump to an indwelling IV catheter (plastic tube) in a vein. - Cyclophosphamide, given by IV infusion over 15 minutes on day 5 of each cycle. - Prednisone, given by mouth (pills) twice a day on days 1 through 5 of each cycle. - Pegfilgrastim, given by injection under the skin once on day 6 of each cycle to help normal bone marrow cells recover from the chemotherapy and produce neutrophils, a type of white blood cell. - G-CSF, given by injection under the skin once a day to boost white cell production. - Patients also take a combination of antibiotics 3 days a week during EPOCH to prevent infection while resistance is lowered because of the chemotherapy. Treatment continues for six to eight cycles, depending on the response to therapy. Patients who show no signs of disease at the end of treatment will be seen periodically at the Clinical Center for follow-up tests and examinations. Patients whose disease does not disappear entirely, gets worse, or recurs after having disappeared will be offered participation in other appropriate research protocols, if available, or will be returned to the care of the referring physician.
Details: The paradigm of combining therapeutic agents with non-overlapping toxicities for the treatment of malignancy produces clinical remissions and cures in a number of tumor types. A new class of agents, humanized and chimerized monoclonal antibodies, typically have little or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic chemotherapy. It has become clear that in certain lymphomas and breast cancers, the combination of monoclonal antibodies and chemotherapy improves response rate and the quality of the response compared with that achieved by treatment with either agent alone. The clinical outcome for patients with T cell non-Hodgkin's lymphoma is significantly inferior to the outcome of patients with B-cell non-Hodgkin's lymphoma. In most reports less than 20% of patients with T cell lymphoid malignancies remain free of disease at 5 years. Although EPOCH chemotherapy appears to improve outcome in patients with B-cell lymphoid malignancy, it does not improve the outcome for those with T-cell malignancy. In this study we plan to investigate the safety and in a preliminary fashion the antitumor activity of Alemtuzumab and EPOCH infusional chemotherapy in patients with non B-cell CD52-expressing lymphoid malignancies. The purpose of this trial is to establish a dose of Alemtuzumab for evaluation in Phase II trials in specific CD52-expressing malignancies.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: ELIGIBILTY CRITERIA: CD52-expressing lymphoid malignancy, confirmed by pathology or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology, NCI. Patients with T & NK cell malignancy without accessible tissue for flow cytometry analysis may be treated on this study. Patients with untreated aggressive T & NK lymphomas, including but not limited to peripheral T cell lymphoma (nos), gamma-delta hepatosplenic T cell lymphoma, subcutaneous panniculitis-like T cell, NK-T cell lymphoma confirmed by pathology or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology, NCI. Patients with anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible. Age greater than or equal to 17 years. Laboratory tests: Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 ml/min; bilirubin less than 2.0 mg/dl unless due to Gilbert's, AST and ALT less than or equal to 3x ULN (AST and ALT is less than or equal to 6x ULN for patients on hyperalimentation) and; ANC is greater than or equal to 1000/mm(3), platelet greater than or equal to 75,000/mm(3); unless impairment due to respective organ involvement by tumor. No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. HIV negative, because of the unknown effects of combined therapy with chemotherapy and an immunosuppressive agent on HIV progression. Signed informed consent. Willing to use contraception. Not pregnant or nursing, because of the unknown effects of Alemtuzumab on the developing fetus and infant. No serious underlying medical condition or infection that would contraindicate treatment. Patients with CNS involvement are eligible for treatment on this study.
Total Enrollment: 24
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: 030304; 03-C-0304
Study Start Date: September 16, 2003
Record last reviewed: September 15, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069238
Other Lymphoma Studies:
1. Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
2. Phase I Study of Intrathecal Topotecan
3. Arsenic Trioxide With or Without Tretinoin in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy
4. Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
5. Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Related Studies:
Other Lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas
|
|
|
|
|
|
|
|
