Radiolabeled Monoclonal Antibody in Treating Patients With Previously Treated Large Cell Lymphoma

NCT ID: NCT00028613

Last Updated: 2014-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2001-10-31

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances such as radioactive iodine to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibodies in treating patients who have large cell lymphoma that has been previously treated.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose of iodine I 131 monoclonal antibody Lym-1 in patients with previously treated diffuse large cell lymphoma.
• Determine the safety of this drug in these patients.
• Determine the response of patients to this drug.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive unlabeled monoclonal antibody Lym-1 IV over 40 minutes followed 15-30 minutes later by iodine I 131 monoclonal antibody Lym-1 IV over 2 minutes.

Cohorts of 3-6 patients receive escalating doses of iodine I 131 monoclonal antibody Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed weekly for 8 weeks and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 8-36 patients will be accrued for this study.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

iodine I 131 monoclonal antibody Lym-1

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Histologic diagnosis of B-cell diffuse large cell lymphoma (REAL classification system) confirmed by an independent central pathology reviewer.
• The tumor's B-cell phenotype will be confirmed by positive L-26 (CD20).
• Previous treatment with 2 common combination chemotherapy regimens. Patients previously treated with unlabeled monoclonal antibody therapy are eligible.
• Men or women at least 18 years of age.
• Karnofsky Performance Score (KPS) estimated to be > 60 at the time of the scheduled therapeutic dose of 131I-Lym-1.
• Life expectancy estimated to be at least 3 months from the time of the therapeutic dose of 131I Lym-1.
• Measurable disease demonstrable by physical examination or computerized tomography (CT).
• CT scan evidence of at least one indicator lesion with at least one diameter that measures > 2 cm. (The CT scan should be done within 2 weeks of the imaging study.)

Exclusion Criteria

• Inability or unwillingness to comply with the following:
• Bone marrow biopsy
• Return for follow-up visits
• Remaining motionless for extended periods of time for imaging procedures
• Serial blood/urine sampling (for dosimetry patients only)
• Pregnancy (Women of childbearing potential must be practicing an effective method of contraception.)
• Presence of a second malignancy except for basal cell skin carcinoma or carcinoma in-situ of the cervix
• Presence of active lymphomatous meningitis or other CNS involvement with lymphoma.
• HIV positive patients.
• Prior total body irradiation, or a course of prior radiation > 3,000 cGy delivered to > 20% of the central marrow or the lumbar vertebrae within 6 months of screening.
• Serum creatinine or total bilirubin > 2 x the upper limit of normal.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase > 3 x the upper limit of normal.
• Significant marrow lymphoma (defined as lymphoma cells constituting greater than 20% of the hematopoietic marrow elements from an iliac crest biopsy). A prior bone marrow biopsy is acceptable if it meets the following criteria:
• If there is prior bone marrow involvement, the biopsy must be performed within 45 days of screening.
• If there is no prior bone marrow involvement, the biopsy must be performed within 90 days of screening
• WBC count < 3,500/mm3, granulocyte count < 1,500/mm3, or platelet count < 125,000/mm3.
• Positive human anti-mouse antibodies (HAMA) serum values, defined as > 74 ng/mL at screening.
• Patients who have not recovered from toxicities of most recent anti-lymphoma therapy.
• Treatment with:
• Colony stimulating factor G-CSF or GM-CSF within 120 hours of screening laboratory assessment.
• Erythropoietin (EPO) within a month of screening laboratory assessment
• Whole blood or platelet transfusion within 120 hours of screening laboratory assessment
• History or electrocardiographic (ECG) evidence of Q-wave myocardial infarction within 6 months of screening or congestive heart failure (CHF; NYHA Stage III or IV).
• Known hypersensitivity to iodine or iodine-containing organic substances.
• Patients who require therapy with anticoagulants or antiplatelet drugs which cannot be discontinued during the study.
• Patients who are known to have antiplatelet antibodies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Omer N. Koc, MD

Role: STUDY_CHAIR

Case Comprehensive Cancer Center

Locations

Ireland Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CWRU-BRLX-1400

Identifier Type: -

Identifier Source: secondary_id

BRLX-303680

Identifier Type: -

Identifier Source: secondary_id

CWRU-090036

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-2038

Identifier Type: -

Identifier Source: secondary_id

BRLX1400

Identifier Type: -

Identifier Source: org_study_id