Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Primary Central Nervous System Non-Hodgkin Lymphoma

NCT01973062 | Terminated Phase 2 Results DMC

• 2 other identifiers: CASE4413NCI-2013-01993
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well yttrium Y 90 ibritumomab tiuxetan and rituximab work in treating patients with recurrent or refractory primary central nervous system non-Hodgkin lymphoma. Radiolabeled monoclonal antibodies, such as yttrium 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.

Conditions

Primary Central Nervous System Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Radiographic Response Assessed by MRI or FDG-PET/MRI

  Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids

  Up to 2 years

Secondary Outcomes (4)

• Progression Free Survival

  Up to 2 years

• Overall Survival

  Up to 2 years

• Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.

  Up to 30 days following the last dose of study treatment

• Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI

  At day 11

Study Arms (1)

rituximab and yttrium Y 90 ibritumomab tiuxetan

EXPERIMENTAL

Patients receive rituximab IV on day 1. Within 7 to 9 days, patients receive rituximab IV and yttrium Y 90 ibritumomab tiuxetan IV in the absence of disease progression or unacceptable toxicity.

Biological: rituximab; Radiation: yttrium Y 90 ibritumomab tiuxetan

Interventions

rituximab BIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan

rituximab and yttrium Y 90 ibritumomab tiuxetan

yttrium Y 90 ibritumomab tiuxetan RADIATION

Given IV

Also known as: 90Y ibritumomab tiuxetan, IDEC Y2B8, Y90 Zevalin, Y90-labeled ibritumomab tiuxetan

rituximab and yttrium Y 90 ibritumomab tiuxetan

Eligibility Criteria

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

You may qualify if:

• Patients with histological diagnosis of recurrent or refractory primary central nervous system (CNS) lymphoma with at least 1 measurable gadolinium enhancing lesion on brain MRI scans
• Karnofsky performance status (KPS) \>= 60
• Patients could not have had more than 3 prior therapy regimens for the treatment of PCNSL
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
• Platelets \>= 100 x 10\^9/L
• Hemoglobin (Hgb) \> 10 g/dL
• Serum total bilirubin =\< 1.5 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) =\< 3.0 x ULN
• Aspartate aminotransferase (AST) =\< 3.0 x ULN
• Serum creatinine =\< 1.5 x ULN
• Minimum interval since completion of radiation treatment is 12 weeks
• Minimum interval since last drug therapy:
• weeks since the completion of non-cytotoxic agents
• weeks since the completion of a non-nitrosourea-containing regimen
• weeks since the completion of a nitrosourea-containing regimen

You may not qualify if:

• Pregnant or breast-feeding women
• Patients unwilling or unable to comply with the protocol
• Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active infection, uncontrolled diabetes, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness, etc.) that could cause unacceptable safety risks or compromise compliance with the protocol
• Known diagnosis of human immunodeficiency virus (HIV) infection; prior radioimmunotherapy, prior myeloablative therapy with autologous bone marrow transplantation or peripheral stem cell rescue, and prior external beam radiation therapy to more than 25% of active bone marrow
• Patients who have received filgrastim (G-CSF) or sargramostim (GM-CSF) within 2 weeks before treatment or major surgery within the prior 4 weeks

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Rituximab; ibritumomab tiuxetan

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Manmeet Ahluwalia, MD
• Organization: Case Comprehensive Cancer Center

ahluwam@ccf.org

216-444-6145

Study Officials

• Manmeet Ahluwalia, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: March 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 24, 2020
• Results First Posted: July 20, 2018

Record last verified: 2020-07

Locations

US (1)