A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma
- Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric
patients with progressive or recurrent glioblastoma multiforme or anaplastic
- Determine the safety of this drug in these patients.
- Determine the efficacy of this drug in these patients.
- Compare the efficacy of this drug in patients with different histological types of
tumor, degrees of transferrin receptor expression, and serum antidiphtheria antibody
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to
1 of 2 treatment groups by age (5-9 vs 10-18).
All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2
intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 (Tf-CRM107).
- Group 1 (ages 5-9): Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter.
Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity. Three
cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum
tolerated dose (MTD) is determined.
- Group 2 (ages 10-18): Patients receive intratumoral Tf-CRM107 as in group 1. Two
cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is
The MTD in both groups is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.
Patients are followed monthly for 6 months and then every 3 months for 6 months.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Patrick Rossi, MD
United States: Federal Government
|Children's Hospital of Orange County||Orange, California 92668|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|