Trial Outcomes & Findings for Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation (NCT NCT00659334)

Results Overview

Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2\* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

116 participants

Primary outcome timeframe

24 hours (some patients between 3 and 72 hours) after administration of Combidex

Results posted on

2022-12-21

Participant Flow

Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU.

There are seven groups in the study. In Groups 1(adults) and 4(pediatric) subjects receive the Combidex infusion only. In Groups 2(adult) and 5(pediatrics) subjects receive Combidex and undergo neurosurgery. In Groups 3(adult) and 6(pediatric) subjects undergo surgery with tissue exam; and in Group 7(adult only) subjects with MS or stroke.

Participant milestones

Participant milestones
Measure	Combidex Only (Group 1) Adults with brain tumor to receive Combidex infusion only	Combidex and Neurosurgery (Group 2) Adults with brain tumors to receive Combidex infusion and neurosurgery	Neurosurgery Only (Group 3) Adults with brain tumors to receive neurosurgery only (NO Combidex)	Combidex Only (Group 4) Children with brain tumors to receive Combidex only	Combidex and Neurosurgery (Group 5) Children with brain tumors to receive Combidex and neurosurgery	Inflammatory Lesions (Group 7) Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
Overall Study STARTED	46	41	5	2	1	21
Overall Study COMPLETED	38	36	5	2	1	20
Overall Study NOT COMPLETED	8	5	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Combidex Only (Group 1) Adults with brain tumor to receive Combidex infusion only	Combidex and Neurosurgery (Group 2) Adults with brain tumors to receive Combidex infusion and neurosurgery	Neurosurgery Only (Group 3) Adults with brain tumors to receive neurosurgery only (NO Combidex)	Combidex Only (Group 4) Children with brain tumors to receive Combidex only	Combidex and Neurosurgery (Group 5) Children with brain tumors to receive Combidex and neurosurgery	Neurosurgery Only (Group 6) Children with brain tumors to receive neurosurgery only, NO Combidex	Inflammatory Lesions (Group 7) Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
Overall Study Screen Failure	8	5	0	0	0	0	1

Baseline Characteristics

Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combidex Only (Group 1) n=46 Participants Adults with brain tumor to receive Combidex infusion only	Combidex and Neurosurgery (Group 2) n=41 Participants Adults with brain tumors to receive Combidex infusion and neurosurgery	Neurosurgery Only (Group 3) n=5 Participants Adults with brain tumors to receive neurosurgery only (NO Combidex)	Combidex Only (Group 4) n=2 Participants Children with brain tumors to receive Combidex only	Combidex and Neurosurgery (Group 5) n=1 Participants Children with brain tumors to receive Combidex and neurosurgery	Neurosurgery Only (Group 6) Children with brain tumors to receive neurosurgery only, NO Combidex	Inflammatory Lesions (Group 7) n=21 Participants Adults with Inflammatory lesions (stroke or MS) to receive Combidex only	Total n=116 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	—	0 Participants n=8 Participants	3 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	35 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	19 Participants n=8 Participants	96 Participants n=24 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	2 Participants n=8 Participants	17 Participants n=24 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 13.2 • n=5 Participants	48.4 years STANDARD_DEVIATION 12.8 • n=7 Participants	45.4 years STANDARD_DEVIATION 14.2 • n=5 Participants	14.7 years STANDARD_DEVIATION 1.4 • n=4 Participants	14.1 years STANDARD_DEVIATION 0 • n=21 Participants	—	43.0 years STANDARD_DEVIATION 15.3 • n=8 Participants	48.8 years STANDARD_DEVIATION 15.1 • n=24 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	17 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	—	8 Participants n=8 Participants	50 Participants n=24 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	24 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	—	13 Participants n=8 Participants	66 Participants n=24 Participants
Region of Enrollment United States	46 participants n=5 Participants	41 participants n=7 Participants	5 participants n=5 Participants	2 participants n=4 Participants	1 participants n=21 Participants	—	21 participants n=8 Participants	116 participants n=24 Participants

PRIMARY outcome

Timeframe: 24 hours (some patients between 3 and 72 hours) after administration of Combidex

Population: No eligible participants were identified to enroll in Group 6. Data not collected for Group 3 due to early study termination.

Signal intensity change in participants with Pre and 24 hours Post Combidex on T1, T2, T2\* MRI sequences will be assessed (some patients undergo scans at 3 and 72 hours in order to assess radiographic changes at these time points). Combidex will be administered in dose 2.6 mg/kg in adults with high and low grade gliomas, metastases, meningiomas, and PNET; and in pediatric patients with astrocytomas grade i-iv, brain stem gliomas, ependymomas, CNS germ cell tumors, and PNET.

Outcome measures

Outcome measures
Measure	Combidex Only (Group 1) n=46 Participants Adults with brain tumor to receive Combidex infusion only	Combidex and Neurosurgery (Group 2) n=41 Participants Adults with brain tumors to receive Combidex infusion and neurosurgery	Neurosurgery Only (Group 3) Adults with brain tumors to receive neurosurgery only (NO Combidex)	Combidex Only (Group 4) n=2 Participants Children with brain tumors to receive Combidex only	Combidex and Neurosurgery (Group 5) n=1 Participants Children with brain tumors to receive Combidex and neurosurgery	Neurosurgery Only (Group 6) Children with brain tumors to receive neurosurgery only, NO Combidex	Inflammatory Lesions (Group 7) n=21 Participants Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
Number of Participants Who Experience Optimal Imaging in Adult and Pediatric Brain Tumors to Establish Timing and Sequencing Parameters of Combidex.	36 Participants	35 Participants	—	2 Participants	1 Participants	—	20 Participants

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combidex Only (Group 1) n=46 participants at risk Adults with brain tumor to receive Combidex infusion only	Combidex and Neurosurgery (Group 2) n=41 participants at risk Adults with brain tumors to receive Combidex infusion and neurosurgery	Neurosurgery Only (Group 3) n=5 participants at risk Adults with brain tumors to receive neurosurgery only (NO Combidex)	Combidex Only (Group 4) n=2 participants at risk Children with brain tumors to receive Combidex only	Combidex and Neurosurgery (Group 5) n=1 participants at risk Children with brain tumors to receive Combidex and neurosurgery	Neurosurgery Only (Group 6) Children with brain tumors to receive neurosurgery only, NO Combidex	Inflammatory Lesions (Group 7) n=21 participants at risk Adults with Inflammatory lesions (stroke or MS) to receive Combidex only
Nervous system disorders Disease Progression	19.6% 9/46 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	24.4% 10/41 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	40.0% 2/5 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/2 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/1 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	— 0/0 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/21 Other adverse events were collected/assessed, but none affected over 5% of the patient population.
Nervous system disorders Cerebellar Infraction	0.00% 0/46 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/41 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/5 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	50.0% 1/2 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/1 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	— 0/0 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/21 Other adverse events were collected/assessed, but none affected over 5% of the patient population.
Infections and infestations Post-Op Infection	2.2% 1/46 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/41 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/5 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/2 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/1 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	— 0/0 Other adverse events were collected/assessed, but none affected over 5% of the patient population.	0.00% 0/21 Other adverse events were collected/assessed, but none affected over 5% of the patient population.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Edward Neuwelt

OHSU Knight Cancer Institute

Phone: 503-494-5626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place