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

Lymphoma Clinical Trial

Official title:

Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00028613
• Other study ID #: BRLX1400
• Secondary ID: CWRU-BRLX-1400BR
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2002
• Last updated: January 8, 2014
• Start date: March 2001
• Est. completion date: October 2001

Study information

• Verified date: January 2014
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: October 2001
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Radiation:
• iodine I 131 monoclonal antibody Lym-1

Locations

Country	Name	City	State
United States	Ireland Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,