Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma

NCT00484874 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: J0703NA_00005743
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.

Conditions

Hodgkin's Disease

Keywords

Hodgkin's lymphoma; Radioimmunotherapy; Bexxar; I-131 Tositumomab; Safety; Efficacy; Nuclear Medicine; Monoclonal antibody; Radiolabeled

Outcome Measures

Primary Outcomes (2)

• Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma.

  2 years

• Overall and Complete Response Rates

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CTI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  12 weeks post therapy

Secondary Outcomes (2)

• Median Time to Progression Following I-131 Tositumomab Therapy.

  From time measurement criteria are met for response until first date that recurrent or progressive disease is objectively documented, assessed up to 5 years.

• Frequency of Visualization of Hodgkin's Lymphoma With I-131 Tositumomab Imaging and Tumor Radiation Absorbed Dose

  up to 1 week post-intervention

Study Arms (1)

A Single Dose of I-131 Tositumomab

EXPERIMENTAL

I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.

Drug: I-131 Tositumomab therapeutic regimen

Interventions

I-131 Tositumomab therapeutic regimen DRUG

Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.

Also known as: Brand name: Bexxar

A Single Dose of I-131 Tositumomab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven Hodgkin's lymphoma that is relapsed or refractory and the patient has previously had a transplant or is ineligible for transplant
• All stages and histologic subtypes of Hodgkin's lymphoma
• Malignant cells may be CD20+ or CD20-
• May have previously had either a non-myeloablative or myeloablative allogeneic or autologous stem cell transplant
• If prior history of greater than 1 transplant, eligible if other entry criteria are met
• No upper limit on the amount of prior chemotherapy
• Must be at least 4 weeks out from their most recent chemotherapy or radiation therapy, 6 weeks if the last regimen included BCNU, or mitomycin
• Age 18 or greater
• Karnofsky performance status ≥ 60
• Organ and marrow function within 4 weeks of registration on the protocol as defined below:
• Leukocytes \>2,000/mm3
• Absolute neutrophil count \>1,000/ mm3
• Platelets \>75,000/ mm3
• Hemoglobin \>7 g/dL
• Creatinine \<2.5 mg/dL

You may not qualify if:

• Receiving any other investigational agents at the same time
• Hypocellular bone marrow (less than or equal to 10% cellularity) or marked decrease in any one (or more) hematopoietic precursor within 4 weeks of registration on the protocol
• Inability to follow basic radiation safety precautions
• Active infections requiring intravenous antibiotics until after resolution of the infection

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Heather Jacene, MD
• Organization: Dana-Farber Cancer Institute

hjacene@partners.org

617-632-3767

Study Officials

• Richard L Wahl, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 11, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2014
• Study Completion: November 1, 2015
• Last Updated: August 1, 2018
• Results First Posted: August 1, 2018

Record last verified: 2018-07

Locations

US (1)