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Home > "C" Clinical Trials Conditions > Campath-1H for Treating Adult T-Cell Leukemia  Campath-1H for Treating Adult T-Cell Leukemia
Campath-1H for Treating Adult T-Cell Leukemia
For Condition: Acute T-Cell Leukemia-Lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the safety and effectiveness of Campath-1H for treating patients with adult T-cell leukemia (ATL). ATL is caused by a virus called HTLV-1 that infects lymphocytes (white blood cells) called T-cells. Cancerous cells can be found not only in the blood, but also in the skin, lungs, lymph nodes, liver, bone, bone marrow, spleen, and meninges (tissues covering the brain). There are four categories of ATL, based on the aggressiveness of disease smoldering, chronic, lymphoma, and acute. Campath-1H is a monoclonal antibody that attaches to and kills normal and cancerous lymphocytes, including T cells. Although Campath-1H is an experimental drug for treating ATL, it is approved by the Food and Drug Administration for treating chronic lymphocytic leukemia. Patients 18 years of age and older with any type of ATL except smoldering may be eligible for this study. Candidates will be screened with a medical history and physical examination, photos of skin lesions, measurement of lesions such as lymph nodes and skin nodules, blood and urine tests, electrocardiogram (EKG), chest x-ray, CT scan or ultrasound of the abdomen, skin biopsy, bone marrow aspirate and biopsy, skin test, and lumbar puncture (spinal tap). Participants will undergo treatment in two phases, as follows: - Dose escalation phase: Patients will receive an infusion of Campath-1H daily. The initial dose will be low and will be increased daily as long as there are no side effects, or only mild reactions, until the patient is receiving the maximum dose of 30 milligrams per day. - Stable dose phase: Patients will receive three infusions of Campath-1H per week for up to 12 weeks. In addition, patients will be evaluated during treatment with the following tests and procedures: - History and physical examination every 4 weeks. - Blood tests every 4 weeks. - CT scans to measure the size of the tumors every 4 weeks. - Skin biopsies and lymph note aspirates: Up to five biopsies and five aspirates may be taken to help diagnose the disease and evaluate the effect of Campath-1H on the cancer. - Bone marrow or lymph node biopsy: These procedures may be done to document or monitor disease progress. Patients will receive treatment for up to 12 weeks as long as the patient is benefiting. If all the cancer disappears early in the early course of treatment, Campath-1H will be stopped after 8 weeks. Patients whose cancer worsens with treatment will be taken off the medication.
Details: The purpose of the study is to determine: (1) the clinical response to Campath-1H of patients with adult T-cell leukemia; (2) to define the time course of Campath-1H saturation of CD52 in lymph node and peripheral blood leukemia cells of patients with ATL; (3) the toxicity of Campath-1H in patients who have ATL. This study represents an extension of Metabolism Branch NCI protocols for the treatment of ATL. The scientific basis for these therapeutic studies is that the leukemic cells of patients with ATL express high levels of CD52 on their surface consistent with the levels of expression observed on normal T-cells. Campath-1H exerts its antitumor effects through complement-mediated and antibody dependent cell-mediated toxicity. Eligible patients with ATL will be treated with the standard phase II dose of Campath-1H. Clinical response will be evaluated using routine immunological and clinical evaluation and by monitoring the time course of saturation of CD52 and the absolute number of residual circulating malignant cells by FACS analysis using two fluorochrome-labeled antibodies to the Il-2 receptor, anti-Tac and 7G7/B6 and CD52, as well as antibodies to CD3, CD4, CD7, and CD8. Furthermore, responses will be evaluated in patients with leukemia by polymerase chain reaction for T cell receptor genes and HTLV-1. If as anticipated the therapy with Campath-1H yields some partial and complete remissions in patients with ATL, we will propose that it be used in association with other therapeutic approaches under investigation by the metabolism branch including saturating doses of Zenapax (Registered Trademark) or (90) Y-armed Zenapax (Registered Trademark). This latter approach is of particular interest because of the known efficacy of Campath-1H in leukemia and its relative ineffectiveness in nodal disease and the known high response rate with (90) Y-armed Zenapax (Registered Trademark) in lymph node metastases. Patients treated at the Clinical Center, National Institutes of Health selected for entry on the present study with Campath-1H will have failed treatment with saturating doses of Zenapax (Registered Trademark).
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must have serum antibodies directed to HTLV-I. All patients must have a histologically confirmed diagnosis of adult T-cell leukemia/lymphoma and more than 10% of the malignant cells must express CD52 and CD25. All stages of Tac-expressing adult T-cell leukemia except smoldering are eligible: patients with chronic, lymphoma or acute ATL are eligible. Patients must have measurable disease. All patients with greater than 10% abnormal (i.e., Tac homogenous strongly expressing) PBMC in the peripheral blood will be deemed to have measurable disease. The patient must have a granulocyte count of at least 1000/mm(3) and a platelet count of greater than or equal to 50,000/mm(3). Patients must have a creatinine of less than 3.0 mg/dl. Omission of cytotxic chemotherapy for ATL for 3 weeks prior to entry into the trial is required. However patients receiving a stable dose of corticosteroids for at least three to four weeks without evidence of tumor response will be eligible. Patients must have a life expectancy of greater than 2 months. Eligible patients must be greater than or equal to 18 years old. There is no upper age limit. Patients must have SGOT and SGPT value less than or equal to 2.5-fold greater than the upper limit of normal and bilirubin less than or equal to 3.0/dl. If a liver function test is judged to be elevated due to the underlying ATL, this parameter will be considered an unevaluable parameter for toxicity determinations. Patients must be able to understand and sign an Informed Consent form. All patients must use adequate contraception during participation in this trial and for three months after completing therapy. EXCLUSION CRITERIA: Patients with symptomatic leukemic meningitis will be excluded. However, patients that have both ATL and another HTLV-I-associated disease, tropical spastic paraparesis (TSP), will be included. Pregnant and nursing patients are not eligible for the study. Because the effects of CAMPATH-1H on the developing fetus are unknown pregnant women will be excluded. Breast-feeding in patients with HTLV-1 infection is contraindicated because of the risk of transmission of the virus to the child. In addition, CAMPATH-1H may be present in breast milk and produce adverse events in the breast-feeding child. HIV positive patients are excluded from the study. CAMPATH-1H may produce a different pattern of toxicities in patients with HIV infection and in addition the depletion of T cells produced by CAMPATH-1H may have adverse effects on HIV positive individuals. Patients with smoldering ATL are excluded. Patients who previously received Campath-1GH are ineligible.
Total Enrollment: 29
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: 030194; 03-C-0194
Study Start Date: May 19, 2003
Record last reviewed: March 17, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061048
Other Acute T-Cell Leukemia-Lymphoma Studies:
1. Campath-1H for Treating Adult T-Cell Leukemia
Related Studies:
Other Acute T-Cell Leukemia-Lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Campath-1H for Treating Adult T-Cell Leukemia
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