Trial Outcomes & Findings for Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma (NCT NCT00387023)

Last Updated: 2013-11-18

Results Overview

Tumor response to therapy measured by tumor size as measured radiographically at baseline and at three months from baseline. Tumor response classified as complete response (CR) or partial response (PR), or stable disease (SD), or progressive disease (PD) using International Workshop Standardized Response Criteria (IWC) for Non-Hodgkin's Lymphomas. If the orbital/ocular adnexal lymphoma was not evaluable radiographically, clinical evaluation using slit lamp biomicroscopy was used to assess PR or CR.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

3 months

Results posted on

2013-11-18

Participant Flow

All recruitment done at The University of Texas (UT) MD Anderson Cancer Center between August 2004 and November 2007.

Participant milestones

Participant milestones
Measure	Zevalin + Rituximab Rituximab 250 mg/m\^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zevalin + Rituximab n=12 Participants Rituximab 250 mg/m\^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
Age Continuous	60 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Zevalin + Rituximab n=12 Participants Rituximab 250 mg/m\^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
Number of Participants With Complete Response (CR) or Partial Response (PR) CR	10 participants
Number of Participants With Complete Response (CR) or Partial Response (PR) PR	2 participants

Adverse Events

Zevalin + Rituximab

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zevalin + Rituximab n=12 participants at risk Rituximab 250 mg/m\^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
Blood and lymphatic system disorders Transient Pancytopenia	100.0% 12/12 • 7 years and 2 months
Blood and lymphatic system disorders Anemia	8.3% 1/12 • 7 years and 2 months
General disorders Fatigue	66.7% 8/12 • 7 years and 2 months
General disorders Increased Bruisability	58.3% 7/12 • 7 years and 2 months
Musculoskeletal and connective tissue disorders Joint and Muscle Pain	33.3% 4/12 • 7 years and 2 months
Gastrointestinal disorders Nausea	25.0% 3/12 • 7 years and 2 months
General disorders Headache	25.0% 3/12 • 7 years and 2 months
Infections and infestations Fever	8.3% 1/12 • 7 years and 2 months
General disorders Dizziness	8.3% 1/12 • 7 years and 2 months
Skin and subcutaneous tissue disorders Flushing	8.3% 1/12 • 7 years and 2 months

Additional Information

Bita Esmaeli, MD / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place