Antisense102: Pilot Immunotherapy for Newly Diagnosed Malignant Glioma

Plain-language summary

In this Phase 1 trial, the patient's own tumor cells are collected during surgery, treated with an investigational antisense molecule (IGF-1R/AS ODN) designed to shut down a targeted surface receptor protein, then re-implanted in small diffusion chambers placed in the patient's abdomen. The study continues an earlier Phase 1 trial in recurrent glioma and aims to reproduce its safety results while exploring clinical responses in newly diagnosed patients. Eligibility requires an MR-documented gadolinium-enhancing mass consistent with malignant glioma and a WHO Grade IV glioma diagnosis that is immunopositive for IGF-1R.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

david andrews

Intervention

IGF-1R/AS ODN; Surgery with tissue harvest and implantation 20 diffusion chambers in the rectus sheath with IGF-1R/AS ODN within 24 hours of craniotomy, implanted for 48 hours. (Insulin-like growth factor receptor-1 antisense oligodeoxynucleotide)

Start date

9/1/2015

Estimated completion

8/17/2020

Countries

United States

Related genes

Locations

• Philadelphia, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Documentation by MR of a gadolinium-enhancing intraparenchymal mass consistent with malignant glioma.
* Frozen section diagnosis of WHO Grade IV glioma, confirmed with permanent section and immunopositive for IGF-1R.
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or a Karnofsky Performance Score (KPS) of at least 60.
* Must be 18 years of age or older.
* Must sign an approved informed consent.
* Hemodynamically stable, consistent with Standard of Care values for patients undergoing elective tumor resection.

Exclusion Criteria:

* Females who are pregnant, nursing, or not inclined to use adequate contraceptive methods if necessary to prevent pregnancy during the study.
* An active second primary malignancy with the exception of basal cell or squamous cell skin carcinoma.
* Major concomitant medical illness inclusive of severe chronic obstructive pulmonary disease, multiple sclerosis, symptomatic coronary artery disease, heart failure, recent major cerebrovascular accident, brittle diabetes, renal dialysis, end stage liver disease, labile hypertension, or any autoimmune disorder.
* A history of heparin-induced thrombocytopenia or hypersensitivity to heparin, enoxaparin, or pork products.
* An abnormal International Normalized Ratio (INR) of greater than 1.3, if repeatable and refractory to correction by routine methods.
* Documented deep venous thrombosis