Clinical Trial DRUG VRXP-A202
- A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy Plus Cetuximab in Combination with VTX-2337 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Principal Investigator
- Mark Agulnik
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG VRXP-A202
- The goal of this research study is to compare the standard treatment to the standard treatment plus VTX-2337 to see if it helps cancer tumors stop growing or shrink, and if it helps patients with squamous cell carcinoma of the head and neck (SCCHN) live longer. Researchers also want to determine the side effects of the experimental combination of standard treatment and VTX-2337.
- A standard treatment regimen for SCCHN consists of a combination of carboplatin or cisplatin, 5 fluorouracil [5-FU], and cetuximab. This standard treatment is approved by the US Food and Drug Administration (FDA) for treatment of SCCHN. This research study involves adding either VTX-2337 or placebo (an injection that does not contain active drug) to the standard treatment described above. VTX-2337 is an investigational drug that activates multiple components of the body’s immune system (protects the body against disease). An investigational drug is one that is not yet approved by the FDA.
Some of the eligibility criteria include:
- Participants must have squamous cell carcinoma of the head and neck that is recurrent (came back after prior treatment) or metastatic (has spread beyond the head and neck).
- Participants must be 18 years of age or older.
- Description of Treatment
- The treatment period is split into two phases: initial treatment and subsequent treatment. The initial treatment includes six 21-day cycles where participants will receive cisplatin or carboplatin, 5-FU, cetuximab, and study drug/placebo. Starting with Cycle 7, treatment with cisplatin/carboplatin and 5-FU will be discontinued and participants will continue to receive study drug/placebo and cetuximab. Cycles 7 onwards are 28-day cycles instead of 21-day cycles. Participants will continue to receive cetuximab and study drug/placebo until their disease gets worse or they can no longer tolerate the treatment (experience any unacceptable side effects).
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Mark Agulnik
- TPF Induction chemotherapy and ABT-888 (Veliparib) – a Phase 1/Randomized Phase 2 Study in Patients w/ Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck
- A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
- Pazopanib Neoadjuvant Trial In Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613)
- Phase 2 Efficacy and Safety Study of Intravenous GPX-150, an Anthracycline Analog, in Patients with Soft Tissue Sarcoma
- An Open-Label Study to Evaluate the Pharmacokinetics of Doxorubicin following the Concomitant Intravenous Administration of Olaratumab (IMC-3G3) to Patients with Advanced Soft Tissue Sarcoma
- A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy
- Multicenter, Open-Label Phase II Study of Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
- A Phase II Study of Pazopanib with Oral Topotecan in Patients with Metastatic and Non-resectable Soft Tissue and Bone Sarcomas
- Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma (OER-SAR-043)
- A Blanket Protocol to Study Oral Regorafenib in Patients with Refractory Liposarcoma, Osteogenic Sarcoma, and Ewing/Ewing–Like Sarcomas
last updated: 27-Apr-15 03:59 AM
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