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In 2014, Orphan Drug Status was granted by the FDA for glioblastoma multiforme. [6] It is in phase II/III clinical trials for glioblastoma, in phase II clinical trials for non-small cell lung cancer, and in phase I clinical trials for the treatment of other solid tumors. [7] Phase I results were presented at ASCO in 2016. [7]
A pivotal clinical trial carried out in the early 1970s showed that among 303 GBM patients randomized to radiation or best medical therapy, those who received radiation had a median survival more than double those who did not. [79] Subsequent clinical research has attempted to build on the backbone of surgery followed by radiation.
Anaplastic astrocytoma, glioblastoma multiforme, metastatic malignant melanoma: Myelosuppression, Stevens–Johnson syndrome (rare), pneumonitis (rare) and hepatitis (rare). Thiotepa: IV, topical Alkylates DNA. Breast, ovarian, and baldder cancer Myelosupression, embryo-fetal toxicity, hepatotoxicity (rare) [19] Trabectedin: IV Alkylates DNA.
An open label, multicenter, global phase 2 clinical trial called STARTRK-2 started in 2015 to test the drug in patients with ROS1/NTRK/ALK gene rearrangements. [33] Lorlatinib (also known as PF-06463922) was shown in an ongoing Phase 2 clinical trial to be effective in some ROS1+ NSCLC patients, and treats the cancer in the brain as well as the ...
The first randomized clinical trial evaluating TTFields was published in November, 2014, and evaluated efficacy of this approach in patients with recurrent glioblastoma. [22] This trial was the primary basis for regulatory approval of NovoTTF-100A / Optune in the United States and Europe. [22]
The Glioblastoma Foundation (GF) is a United States non-profit charitable organization established in June 2016 in Durham, North Carolina.Operating as a 501(c)(3) organization, the Glioblastoma Foundation focuses on research, providing support, and promoting awareness for glioblastoma, a highly aggressive form of brain cancer.
Temozolomide is an alkylating agent used to treat serious brain cancers; most commonly as second-line treatments for astrocytoma and as the first-line treatment for glioblastoma. [4] [6] [7] Olaparib in combination with temozolomide demonstrated substantial clinical activity in relapsed small cell lung cancer. [8] It is available as a generic ...
The U.S. Food and Drug Administration (FDA) approved entrectinib based on the evidence from four clinical trials of 355 patients with various types of solid tumors: Trial 1 (EudraCT 2012-000148-88), Trial 2 (NCT02097810), Trial 3 (NCT02568267), [17] and Trial 4 (NCT02650401). [18]