Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies

NCT ID: NCT01224821

Last Updated: 2016-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-12-31
• Study Completion Date: 2008-05-31

Brief Summary

Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade non-Hodgkin's lymphoma (NHL). The primary objective of this study is to demonstrate that each site could accurately conduct the whole body dosimetry required for the safe and effective dosing of Iodine-131 Anti-B1 Antibody. Additional objectives of this study are to evaluate the efficacy, dosimetry, and safety of Iodine-131 Anti-B1 Antibody.

Conditions

Lymphoma, Non-Hodgkin

Keywords

iodine I 131 tositumomab; anti-B1 Antibody; Bexxar; radioimmunotherapy; tositumomab

Study Design

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

Study Groups

Tositumomab and Iodine I-131 Tositumomab

Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST.

Group Type: EXPERIMENTAL

Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab

Intervention Type: BIOLOGICAL

Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST.

Interventions

Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab

Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients must have a histologically confirmed diagnosis of low-grade non-Hodgkin's B-cell lymphoma or low-grade lymphoma that has transformed to intermediate-, or high-grade lymphoma (transformed lymphoma) according to the Working Formulation for Clinical Usage (IWF A, B, and C).
• Patients must have evidence that their tumor tissue expresses the CD20 antigen.
• Patients must have progressive disease of either low-grade or transformed lymphoma within one year of completion of the last chemotherapy regimen administered.
• Patients must have been previously treated with at least one chemotherapy regimen that included an anthracycline or anthracenedione.
• Patients must have a performance status of at least 60% on the Karnofsky Scale and anticipated survival of at least three months.
• Patients must have an absolute granulocyte count of over 1,500 /mm3 and a platelet count above 100,000 /mm3 within seven days of study entry. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
• Patients must have normal renal function (creatinine less than 2.0 mg/dL) and hepatic function (bilirubin less than 2.0 mg/dL) within seven days of study entry.
• Patients must have bi-dimensionally measurable or evaluable progressive lymphoma disease (at least a 25% increase in tumor size or new sites of disease when compared to the last best disease response). Progression must have occurred within 12 months of the preceding response.
• Patients must be at least 18 years of age.
• Patients must give written informed consent and sign an approved informed consent form prior to study entry.

Exclusion Criteria

• Patients with more than an average of 25% of the intertrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically at study entry.
• Patients who have received cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within FOUR weeks prior to study entry (six weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of toxicity. The use of steroids must have been discontinued (except maintenance-dose steroids) at least one week prior to study entry and patients must then show evidence of stable or progressive disease.
• Patients with prior hematologic stem cell transplant following high-dose chemotherapy or chemo/radiotherapy .
• Patients with obstructive hydronephrosis.
• Patients with evidence of active infection requiring intravenous antibiotics at the time of study entry.
• Patients with New York Heart Association class 3 or 4 heart disease or other serious illness that would preclude evaluation.
• Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which patient has been disease-free for five years.
• Patients with known HIV infection.
• Patients with known brain or leptomeningeal metastases.
• Patients who are pregnant. Patients of child-bearing potential must undergo a pregnancy test within seven days of study entry. Males and females must agree to use effective contraception during the study.
• Patients with previous allergic reactions to iodine. This does not include IV contrast materials.
• Patients who were previously given any monoclonal or polyclonal antibodies of any foreign species for either diagnostic or therapeutic purposes. This includes engineered chimeric and humanized antibodies.
• Patients who previously received radioimmunotherapy.
• Patients with progressive disease in a field that has been previously irradiated with more than 3500 cGy.
• Patients who are on another protocol involving non-approved drugs or biologics.

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

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Study Documents

Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

104731

Identifier Type: -

Identifier Source: org_study_id