Trial Outcomes & Findings for Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen (NCT NCT00074165)

NCT ID: NCT00074165

Last Updated: 2023-07-06

Results Overview

Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2023-07-06

Participant Flow

Participant milestones

Measure	Rituximab and Carboplatin Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen

Baseline characteristics by cohort

Measure	Rituximab and Carboplatin n=17 Participants Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	55.235 years STANDARD_DEVIATION 12.799 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.

Outcome measures

Measure	Rituximab and Carboplatin n=17 Participants Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.	1 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Data not collected due to low accrual and early termination.

Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Data not collected due to low accrual and early termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: Data not collected due to low accrual and early termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data not collected due to low accrual and early termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data not collected due to low accrual and early termination.

Outcome measures

Outcome data not reported

Adverse Events

Rituximab and Carboplatin

Serious events: 16 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rituximab and Carboplatin n=17 participants at risk Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
Blood and lymphatic system disorders Neutropenic Fever	11.8% 2/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
General disorders Unresponsiveness	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Blood and lymphatic system disorders Anemia	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Musculoskeletal and connective tissue disorders Superficial Epidermolysis	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Psychiatric disorders Neurological Symptoms	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Vascular disorders Stroke	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Vascular disorders Chemical Meningitis and Seizures	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Investigations Extended Hospitalization	11.8% 2/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Injury, poisoning and procedural complications Hospitalized for Fall	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
General disorders Death	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Blood and lymphatic system disorders Carotid Artery Tear	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Blood and lymphatic system disorders Electrolyte Imbalance and Increased Blood Sodium	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Respiratory, thoracic and mediastinal disorders Bronchitis	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.
Cardiac disorders Atrial Fibrillation	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.

Other adverse events

Measure	Rituximab and Carboplatin n=17 participants at risk Rituximab: (i.v.) 375 mg/m\^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m\^2 /day x 2 days = 400 mg/m\^2
General disorders Leg Pain	5.9% 1/17 • During study treatment (1 year). Unanticipated Problems (UP) and Adverse Events (AE) were reported to IRB according to OHSU's (coordinating center) policies, procedures and guidelines posted on the OHSU IRB web site. NCI Common Toxicity Criteria used to assess AEs.

Additional Information

Dr. Edward Neuwelt

OHSU Knight Cancer Institute

Phone: 503-494-5626

Email: neuwelte@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place