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A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma 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 A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma Clinical research trials and A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma 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 A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma. A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma 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 A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma 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.

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A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma



A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma

For Condition: B Cell Lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of response.
Details: Patients with CD22(+) B-cell lymphomas will be treated with escalating doses as a 192 hr infusion of immunotoxin in a Phase I study to determine dose limiting toxicity evidence of response.
Eligibility:
Study Type:  Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients with a histologic diagnosis confirmed from a pretreatment biopsy at the Laboratory of Pathology, NCI of one of the following entities: Diffuse small Lymphocytic Lymphoma; Follicular, Small Cleaved cell Lymphoma; Follicular, Mixed Small Cleaved and Large Cell Lymphoma; Follicular Large Cell Lymphoma; Diffuse, Intermediately Differentiated Lymphocytic Lymphoma; Diffuse, Small Cleaved Cell Lymphoma; Diffuse, Mixed Small and Large Cell Lymphoma; Diffuse, Large Cell Lymphoma; Large Cell Immunoblastic Lymphoma; Small Noncleaved Cell Lymphoma. Presence of CD22 antigen on at least 30 percent of tumor cells. Presence of objectively measurable sites of disease. Bone marrow positivity and circulating tumor cells in the peripheral blood will be considered evaluable but not measurable disease. No patients with purely B-cell Lymphosarcoma cell leukemia without nodal or soft tissue involvement. No patients with B-cell chronic lymphocytic leukemia, or B-cell or pre-B-cell acute lymphocytic leukemia, and hairy cell leukemia. Patients with objectively measurable disease outside a radiation port or disease which has clearly progressed within a radiation port. HIV negative. No CNS disease. No pulmonary parenchymal disease. Pleural effusions or ascites may be present. Patients with progression of disease despite at least one standard combination chemotherapy regimen. No chemotherapy for at least two weeks prior to entry. Patients who do not desire or are not candidates for autologous or allogeneic bone marrow transplantation procedures. Life expectancy of at least 3 months Creatinine clearance greater than 60 cc per minute. Total bilirubin less than 1.5 mg/dl. SGPT less than 2 times the upper limit of normal. Albumin greater than 75 percent of the lower limit of normal. If prior treatment with doxorubicin, the radionuclide or echocardiogram ejection fraction shall be at least 35 percent. Performance status 0-2. Not in need of current radiation therapy to alleviate local problems. No prior exposure to murine antibodies. No need for current corticosteroid treatment.
Total Enrollment: 24

Location and Contact Information:

National Cancer Institute (NCI)
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:  910176;  91-C-0176
Study Start Date: July 16, 1991
Record last reviewed: June 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001271

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