Carcinoma, Squamous Cell of Head and Neck Clinical Trial
Official title:
A Phase Ib Study of BKM120 With Weekly Cisplatin and Radiotherapy in High Risk Locally Advanced Squamous Cell Cancer of the Head and Neck
This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.
- This phase Ib study is combining standard chemoradiotherapy with weekly cisplatin and BKM120 to assess tolerability of this combination in high risk patients with locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN). The investigators will also obtain preliminary information about the efficacy of this treatment. - The participant will receive the study drug buparlisib once daily, by mouth, for 45 days. The participant will be given a study drug-dosing diary for each cycle. It will include special instructions for taking the study drug at home. - The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study before and how well they have tolerated their doses. - All participants will receive weekly cisplatin injection. Cisplatin will be given intra-venously (IV) on days: (1, 8, 15, 22, 29, 36 and 43) at DFCI. - All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks, delivered at DFCI. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. - The investigators would like to keep track of the participant's medical condition. Follow-up will continue every 4 to 12 weeks after the end of treatment for the first year and at the investigator's discretion thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03291002 -
Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC
|
Phase 1 | |
| Terminated |
NCT02277184 -
Ficlatuzumab, Cisplatin and IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma
|
Phase 1 | |
| Completed |
NCT01080066 -
A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
|
N/A | |
| Completed |
NCT02585973 -
Dose-escalating AZD1775 + Concurrent Radiation + Cisplatin for Intermediate/High Risk HNSCC
|
Phase 1 | |
| Completed |
NCT01836029 -
Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
|
Phase 2 | |
| Active, not recruiting |
NCT03715946 -
Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03088059 -
Biomarker-based Study in R/M SCCHN
|
Phase 2 | |
| Recruiting |
NCT06003231 -
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
|
Phase 2 | |
| Terminated |
NCT02438995 -
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck
|
Phase 1 | |
| Completed |
NCT02242916 -
State of the Art Photon Therapy Versus Particle Therapy for Recurrent Head & Neck Tumors; a Planning Study
|
N/A | |
| Recruiting |
NCT01876693 -
A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
|
N/A | |
| Terminated |
NCT02655068 -
Phase III Trial of PET/CT vs. CTSurveilance for Head and Neck Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT03509012 -
Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT02296684 -
Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
| Active, not recruiting |
NCT03799744 -
Safety,Tolerability,and Efficacy of VCN-01 With Durvalumab in R/M Head and Neck Squamous Cell Carcinoma
|
Phase 1 | |
| Completed |
NCT03109158 -
NC-6004 With 5-FU and Cetuximab for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03485209 -
Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors
|
Phase 2 | |
| Completed |
NCT01307267 -
A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
|
Phase 1 | |
| Terminated |
NCT02822482 -
Copanlisib in Association With Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss
|
Phase 1/Phase 2 | |
| Completed |
NCT02101034 -
PD 0332991 and Cetuximab in Patients With Incurable SCCHN
|
Phase 1/Phase 2 |