Status:
COMPLETED
Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Glioblastoma
GBM
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to characterize the safety and tolerability of avelumab in combination with Laser Interstitial Thermal Therapy (LITT) for blood barrier disruption in patients with recurren...
Detailed Description
This is an open label, non-randomized Phase I study of intravenous avelumab every 2 weeks to be administered after real-time MRI-guided LITT therapy for patients with a first recurrence of a glioblast...
Eligibility Criteria
Inclusion
- Patients must have histologically proven GBM from the initial resection.
- Patients must have a life expectancy \> 16 weeks. Patients must have a Karnofsky performance status of ≥ 60 or ECOG 0 - 2
- Patient's requirement for dexamethasone should be ≤ 4mg daily or a stable dose at enrollment.
- Patients must have adequate bone marrow, hepatic and renal function and hemoglobin and the test musts be performed within 14 days prior to study Day 1.
- Highly effective contraception for both male and female subjects if the risk of conception exists.
Exclusion
- Known history of autoimmune disorder except diabetes mellitus type 1, vitiligo or hypothyroidism only requiring hormone replacement
- Patients who have received any other therapeutic investigational agent within 30 days of enrollment with the exception of the personalized MTA vaccine (NCT03223103) that can be continued throughout the study.
- Patients who have received any other therapeutic investigational agent within 30 days of enrollment or prior
- Prior placement of intracavitary BCNU-impregnated wafers (Gliadel).
- Prior treatment with checkpoint inhibitors, CTL-4 antibody or other immunotherapy agents
- Presence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatment.
- Prior organ transplantation, including allogeneic stem cell transplantation
- Significant acute or chronic infections including, among others: HIV, AIDS, HBV
- Pregnancy or lactation
- Contact site for full inclusion/exclusion list.
Key Trial Info
Start Date :
June 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03341806
Start Date
June 13 2018
End Date
October 13 2021
Last Update
January 4 2022
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029