Trial of C134 in Patients With Recurrent GBM (C134-HSV-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03657576|
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : May 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme of Brain Anaplastic Astrocytoma of Brain Gliosarcoma of Brain||Biological: C134||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Modified continuous reassessment model (mCRM). Using this statistical method, dose changes occur based upon toxicities (or lack thereof) observed after a 24 day observation period for the initial dose level. If toxicities occurring at any dose were acceptable, doses for subsequent cohorts can be increased by up to 1 log until a maximum tolerated dose is reached. If toxicities are unacceptable then dose de-escalation occurs until a safe acceptable maximum tolerated dosage is defined. However, it should be noted that the dose alterations are not predictable and cannot be predefined, they are statistically determined after each patient using mCRM software.|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of IRS-1 HSV C134 Administered Intratumorally in Patients With Recurrent Malignant Glioma|
|Actual Study Start Date :||September 23, 2019|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2024|
Experimental: C134 Treatment
All patients who enroll will receive C134 inoculation into their tumor (one time procedure with 1-5 inoculation sites)
C134 is a virus that was created from an oncolytic Herpes Simplex Virus (oHSV) known to infect and kill tumor cells. The Investigators have made changes to the original virus to make C134. It efficiently infects tumor cells (not normal healthy cells) and induces an immune response to fight the cancer as well.
- Measure of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: from baseline through month 12 ]Adverse events will be monitored and any changes in status will be recorded for each patient as outlined in CTCAE v4.0 reporting requirements.
- Measure of Progression Free Survival [ Time Frame: pre-study, day 3, day 28, month 3, month 6, month 12 ]Patients will receive contrast-enhanced MRI to monitor progression (changes in tumor volume or tumor enhancement assessed by the iRANO criteria). As indicated in the criteria, biopsy and/or resection may be performed in instances of uncertainty. Determination of time to progression (in months) will be recorded for each patient and median progression-free survival will be calculated for the entire cohort (Kaplan-Meier).
- Measure Overall Survival [ Time Frame: day 0, day 1, day 2, day 3, day 7, day 28, month 3, month 6, month 12 ]Patients survival will be recorded (Kaplan-Meier).
- Measurement of HSV titer [ Time Frame: pre-study, day 28, month 3, month 6, month 12 ]Detection and quantification of HSV antibody titer via ELISA, pfu/mL.
- Composition of the white blood cells [ Time Frame: pre-study, day 2, day 7, day 28, month 3, month 6, month 12 ]White blood cell subset analysis by FACS, as a percent of total white blood cell number.
- Measure interferon levels [ Time Frame: pre-study, day 2, day 7, day 28, month 3, month 6, month 12 ]Intracellular lymphocyte interferon levels will be assessed by FACS analysis ng/mL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657576
|Contact: Norma Miller, RN||(205) firstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Norma Miller, RN 205-996-6169 email@example.com|
|Principal Investigator:||James Markert, MD||University of Alabama at Birmingham|