Clinical Trial DRUG STML-701-0114
- A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Multiforme
- Principal Investigator
- Priya Kumthekar
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG STML-701-0114
- The goal of this research study is to establish the safety and tolerability of the drug SL-701, and to determine its effects on patients with recurrent Glioblastoma Multiforme (GBM) tumors.
- SL-701 is an experimental medication. This means that the United States Food and Drug Administration (FDA) has not yet approved SL-701. SL-701 is an anti-cancer immunotherapy that uses 3 different short proteins, called “peptides,” that are found in certain brain tumors. The immunotherapy is designed to activate the immune system to recognize and kill brain-tumor cells that display proteins similar to the peptides in SL-701.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have tumor recurrence (cancer came back) or progression (cancer is worsening)after initial (first) treatment.
- Participants who received prior cancer chemotherapy with bevacizumab or other VEGF-VEGFR-directed agents (check with the study doctor for any exclusions) cannot participate in this study.
- Description of Treatment
- Participants will receive SL-701 as an injection (shot by needle) along with an additional medication that will make the immune response stronger. This additional medication (poly-ICLC) is referred to as an adjuvant. Participants will also receive bevacizumab (approved by the FDA for the treatment of GBM) in combination with SL-701 and poly-ICLC. To receive study treatment, participants will come to the study center two times per week for the first 2 weeks, every week for the next 2 weeks, and every 2 weeks thereafter through Week 22. After Week 22, participants will come to the clinic every 4 weeks to receive SL-701 and poly-ICLC injections. Bevacizumab will continue to be given every 2 weeks after Week 22.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Priya Kumthekar
- A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation
- A Phase 1 Open-label, Multicenter Study To Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of an Anti-CTLA-4 Human Monoclonal Antibody (AGEN1884), and to Estimate the Maximum Tolerated Dose in Subjects With Advanced or Refractory Cancer
- A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined with Bevacizumab vs. Bevacizumab Monotherapy in Patients with Recurrent Glioblastoma
- A Phase II Trial of Bevacizumab in Patients with Recurrent Solid Tumor Brain Metastases Who Have Failed Whole Brain Radiation Therapy
last updated: 02-Jul-16 02:34 AM
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