We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00001271
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
B Cell Lymphoma Drug: IgG-RFB4-SMPT-dgA Phase 1

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Primary Purpose: Treatment
Official Title: A Phase I Study of Continuous Infusion Immunotoxin IgG-RFB4-SMPT-dgA in Refractory CD22 Positive B-Cell Lymphoma
Study Start Date : July 1991
Estimated Study Completion Date : April 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001271


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001271     History of Changes
Other Study ID Numbers: 910176
91-C-0176
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: June 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Antigen Modulation
Pharmacokinetics
Ricin A Chain

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunotoxins
Immunologic Factors
Physiological Effects of Drugs