Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

IgG-RFB4-SMPT-dgA

Drug
Who is being recruted

B Cell Lymphoma

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 1991

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 1991Actual date on which the first participant was enrolled.

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. 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.

Official TitleA Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma 
Principal SponsorNational Cancer Institute (NCI)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
24 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
B Cell Lymphoma
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Cancer Institute (NCI)Bethesda, United StatesSee the location

CompletedOne Study Center