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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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.