A-dmDT390-bisFv(UCHT1) Immunotoxin Therapy for Patients With Cutaneous T-Cell Lymphoma (CTCL)

The purpose of this study is to further evaluate the clinical responses including response rate and duration and correlate with patient disease stage, tumor burden, anti-DT titer and degree of T cell depletion induced by A-dmDT390-bisFv(UCHT1) fusion protein for patients with surface CD3+ malignant diseases. The secondary objective is to further explore the toxicity profile of A-dmDT390-bisFv(UCHT1) fusion protein for a high-response subgroup of patients with CTCL whose disease stage has not progressed beyond stage IB/IIB with mSWAT \< 50%. Patients will receive full supportive care including transfusions of irradiated washed blood and blood products, antibiotics, antiemetics, etc, when appropriate. However, other anti-neoplastic drugs or hematopoietic growth factors (e.g., erythropoietin, interleukin-11, G-CSF and GM-CSF) are not allowed. Treatment will consist of one 4 day cycle consisting of 2 daily infusions for a total of 8 treatments given on an outpatient basis. Patients will be monitored until day 14 for signs of late drug toxicity by a daily phone call from their health care provider. Subjects will be instructed on how to monitor their own blood pressure at home and encouraged to measure and chart their daily weights that they can report to their health care provider. Off-treatment follow-up will be based upon response. Patients who experience a partial or complete remission who later relapse can receive radiation treatment of new lesions and remain on study as this course is typical of responses to an immunomodulating drug. Patients will have a follow-up visit and testing on day 37. Patients with partial or complete remissions will have another follow-up visit on day 60, then every three months for 1 year, followed by annual visits to assess duration of the response. To accommodate patients, we are offering a travel reimbursement program. Due to the 4 days of consecutive infusions, we will reimburse the expense the patient would incur to travel to the participating institution for treatment. Objectives: 1. Evaluate the overall clinical responses including response rate and duration in a larger group of CTCL high-response patients to see if is higher than current therapies (\>49%). 2. Determine the complete response rate and duration of response of A-dmDT390-bisFv(UCHT1) fusion protein in a larger group of CTCL high-response patients to see if is higher than current therapies (\>20%). 3. Further define toxicities of A-dmDT390-bisFv(UCHT1) regimen in patients with CTCL who have been selected to be free from preexisting cardiac disease and never treated with Campath. 4. Determine if correlations exist between disease stage, tumor burden, anti-DT titer and degree of T cell depletion and response rate and response duration.