Table 2.
Dose Level | Patient number | Age | Gender | Diagnosis | Type of surgery | Number of CD-NSC doses | Best response |
---|---|---|---|---|---|---|---|
1 | 1 | 59 | M | Glioblastoma | Resection | 9 | Progressiona |
1 | 2 | 59 | F | Glioblastoma | Resection | 8 | Stable disease |
1 | 3 | 48 | F | Glioblastoma | Biopsy | 9 | Stable disease |
2 | 4 | 26 | M | Glioblastoma | Resection | 4 | Progression |
2 | 5 | 40 | M | Anaplastic pleomorphic xanthoastrocytoma | Resection | 4 | Progression |
2 | 6 | 64 | M | Glioblastoma | Biopsy | 3 | Progression |
3 | 7 | 65 | F | Glioblastoma | Resection | 2 | Progression |
3 | 8 | 57 | M | Glioblastoma | Resection | 2 | Progression |
3 | 9 | 54 | M | Glioblastoma | Resection | 4 | Progression |
4 | 10 | 51 | M | Glioblastoma | Resection | 3 | Progression |
4 | 11 | 71 | M | Glioblastoma | Resection | 3 | Progression |
4 | 12 | 58 | M | Glioblastoma | Biopsy | 4 | Progression |
4 | 13 | 58 | M | Glioblastoma | Resection | 1b | Not assessed |
4 | 14 | 56 | M | High grade glioma | Resection | 10 | Stable disease |
4 | 15 | 45 | M | Glioblastoma | Biopsy | 3 | Progression |
4 | 16 | 69 | M | Gliosarcoma | Resection | 2 | Not assessedc |
The changes on Patient 1’s first brain MRI after 8 weeks of study treatment were inconclusive, and since he was neurologically stable, he continued with study treatment. When the second brain MRI approximately 8 weeks later showed definite tumor progression, re-review of the first brain MRI determined that those initial changes were from tumor growing, and so best response for him was changed to progression.
Patient 13 received only one dose of CD-NSCs due to migration of the Rickham catheter tip into the lateral ventricle; therefore, the patient was taken off the study.
Patient 16 experienced a dose-limiting toxicity (grade 3 wound infection) 3 weeks after start of study treatment, requiring removal of the Rickham catheter. Since he did not continue study treatment and chose to enroll in a hospice program, no further imaging of his brain was performed.