Protocol Number: 01-C-0235

Title:

Combination Antibody Therapy with Apolizumab (1D10) and Rituximab (CD20) in Relapsed Lymphoma and CLL

Number:

01-C-0235

Summary:

This study will evaluate the safety and effectiveness of two antibodies, apolizumab and rituximab, in treating B-cell lymphomas and chronic lymphocytic leukemia. Rituximab attaches to a molecule called CD20 on B-cell lymphomas and can cause significant shrinkage of these tumors in up to half of patients. It is not as effective against leukemia. Apolizumab attaches to a protein called 1D10 on B-cell cancers and has also been able to shrink tumors in some patients. There is little experience with apolizumab in patients with leukemia. This study will test whether the two antibodies together are more effective against these tumors than either one alone.

Patients 18 years and older with B-cell lymphoma or chronic lymphocytic leukemia may be eligible for this study. Patients' leukemia or lymphoma cells must have both the CD20 and 1D10 antigen receptors and must have had at least one systemic treatment for their disease. Candidates will be screened with a medical history and physical examination, blood and urine tests, electrocardiogram, X-rays and other imaging studies, and possibly a bone marrow aspirate (withdrawal of a small marrow sample through a needle inserted into the hip bone) and lumbar puncture (withdrawal of a small sample of cerebrospinal fluid-fluid that bathes the brain and spinal cord-through a needle placed between the bones in the lower back).

Participants will receive infusions of rituximab and apolizumab once a week for 4 weeks. The first patients in the study will receive lower doses of apolizumab with standard doses of rituximab. If the apolizumab is well tolerated, subsequent patients will receive higher doses. Diphenydramine (Benadryl® (Registered Trademark)), acetominophen (Tylenol® (Registered Trademark)) and rofecoxib (Vioxx® (Registered Trademark)) will also be given to reduce reactions to the antibodies. Patients whose tumors did not grow during the 4 weeks of therapy will be offered additional treatment at a later time. Participants will be followed every 3 months for 1 year, every 4 months the second year, every 6 months the third year and then yearly until their disease worsens or the study ends.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Diagnosis of B-cell lymphoma, Waldenstrom's CLL with surface expression of both CD20 and 1D10 antigen by immunohistochemistry (IHC) or fluorescence of activated cell sorting (FACS) with anti-CD20 and 1D10 antibody. Positive 1D10 expression in a FACS assay is defined as more than 2 times the mean fluorescence intensity (MFI) of the control antibody by FACS or greater than 20% of cells 1D10+ by IHC.

Confirmation of diagnosis in Laboratory of Pathology, NCI or OSU.

Prior therapy with at least one systemic treatment, and not a candidate for potentially curative (i.e., transplant) treatment at the time of study entry. Prior treatment with rituximab greater than or equal to 1 month ago is permitted.

Age greater than 18 years.

ECOG performance status less than or equal to 2.

Major organ function: ANC greater than or equal to 500/microliter, Platelet greater than or equal 25,000/microliter, Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 cc/min; SGPT less than 5 x upper limit of normal; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients with Gilbert's syndrome as defined by greater than 80% unconjugated; unless impairment due to organ involvement by lymphoma.

Provides informed consent.

EXCLUSION CRITERIA:

Pregnancy or nursing. Both male and female patients must be willing to use adequate contraception.

Prior apolizumab treatment.

SActive cardiac disease, cerebrovascular disease or peripheral arterial vascular disease.

Active CNS lymphoma.

Systemic cytotoxic chemotherapy within 3 weeks of enrollment or systemic steroids (except stable doses less than 10 mg/day) within 1 week of enrollment.

Special Instructions: Currently Not Provided

Keywords:

HU 1D10

Rituximab

Lymphoma

Monoclonal Antibody

Recruitment Keywords:

Lymphoma

Non-Hodgkin's Lymphoma

NHL

Chronic Lymphocytic Leukemia

CLL

Leukemia

Conditions:

Non-Hodgkin's Lymphoma

Chronic Lymphocytic Leukemia

Investigational Drug(s):

MoAb: HU 1D10 (Apolizumab)

Ritoximab

Investigational Device(s):

None

Contacts:

CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239

Electronic Address: ncicssc@mail.nih.gov

Citations:

Apoptosis of malignant human B cells by ligation of CD20 with monoclonal antibodies

Inroads in the therapy of indolent lymphomas: exploiting biological insights

Monoclonal antibody therapy of cancer

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Bethesda, Maryland 20892. Last update: 10/23/2004