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

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ClinicalTrials.gov Identifier: NCT01973062
Recruitment Status : Terminated (Funding Unavailable)
First Posted : October 31, 2013
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Primary Central Nervous System Non-Hodgkin Lymphoma Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the radiographic response proportion in patients with refractory or recurrent primary central nervous system lymphoma (PCNSL) to ibritumomab tiuxetan (yttrium Y 90 ibritumomab tiuxetan) when given as an intravenous infusion.

SECONDARY OBJECTIVES:

I. Determine the progression free survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.

II. Determine the overall survival of patients treated with ibritumomab tiuxetan when given as an intravenous infusion.

III. Establish the toxicity profile of ibritumomab tiuxetan in this patient population.

IV. Use positron emission tomography (PET)/magnetic resonance imaging (MRI) to map the distribution of Y-90 ibritumomab tiuxetan, and calculate the Gy delivered based on the activity found within tumor.

OUTLINE:

Patients receive rituximab intravenously (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. Distribution and dose absorbed dose will be assessed on day 11. Quality of life will be assessed at screening, at day 1, 36, 92, and at each follow-up visit.

After completion of study treatment, patients are followed every 3-6 months for 2 years.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Radioimmunotherapy With Zevalin (Ibritumomab Tiuxetan) Therapy for Patients With Refractory or Relapsed Primary Central Nervous System Lymphoma (PCNSL)
Study Start Date : March 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Arm Intervention/treatment
Experimental: rituximab and yttrium Y 90 ibritumomab tiuxetan
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
Given IV
Other Names:
  • IDEC-C2B8
  • IDEC-C2B8 monoclonal antibody
  • Mabthera
  • MOAB IDEC-C2B8
  • Rituxan

Radiation: yttrium Y 90 ibritumomab tiuxetan
Given IV
Other Names:
  • 90Y ibritumomab tiuxetan
  • IDEC Y2B8
  • Y90 Zevalin
  • Y90-labeled ibritumomab tiuxetan




Primary Outcome Measures :
  1. Radiographic Response Assessed by MRI or FDG-PET/MRI [ Time Frame: Up to 2 years ]
    Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Up to 2 years ]
    The number of patients without an unequivocal increase in tumor size or the appearance of new lesions by MRI

  2. Overall Survival [ Time Frame: Up to 2 years ]
    The number of patients alive up to two years after treatment

  3. Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population. [ Time Frame: Up to 30 days following the last dose of study treatment ]
    Number of patients with toxicities related to the study drug

  4. Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI [ Time Frame: At day 11 ]
    Number of Gy delivered to each tumor as calculated using the MIRD dosimetry formula on PET data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    • 3 weeks since the completion of non-cytotoxic agents
    • 4 weeks since the completion of a non-nitrosourea-containing regimen
    • 6 weeks since the completion of a nitrosourea-containing regimen
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients are not on corticosteroids or on stable doses (less than 6 mg daily of dexamethasone) for more than 1 week before baseline imaging
  • Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception
  • Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission; patients with other prior malignancies must be disease-free for >= three years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973062


Locations
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United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Manmeet Ahluwalia, MD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01973062     History of Changes
Other Study ID Numbers: CASE4413
NCI-2013-01993 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2013    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents