Print Friendly Page

Protocol No. NCI9950

Principal Investigator Bruce, Justine

Phase I

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title A Phase I Study of M6620 (VX-970) in Combination with Cisplatin and XRT in Patients with Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC; SDC 10060121)

Objective The purpose of this study is to test the safety of a study drug called VX-970 given with the usual doses of cisplatin along with radiation.

Treatment VX-970 is not FDA-approved. It has been tested in animals and in early clinical trials in persons. This study tests different doses of the study drug to see which is safer in people.

Description During the 1st week of dosing (week -1), VX-970 will be given alone on Day 1 by vein over 60 minutes. Then, beginning one week later, VX-970 will be given in combination with the usual IV cisplatin and radiation therapy once a week for 7 weeks.

Key Eligibility
  • Patients must have histologically or cytologically confirmed head and neck squamous cell cancer (HNSCC) including paranasal sinus cancers but excluding nasopharyngeal carcinomas
  • Clinical staged III or IV HNSCC that is not amenable to surgical resection
  • Patients with primary oropharynx HNSCC must be HPV (-)
  • Carcinoma of the neck of unknown primary site origin (regardless of HPV/p16 status) is eligible
  • Patients must have measurable disease
  • Patients with nasopharyngeal carcinoma, skin SCC, and salivary gland carcinomas are not eligible
  • Patients who are receiving adjuvant chemoradiation after surgical resection of the primary site of disease are not eligible
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are not eligible
  • Patients on tacrolimus or any other immunosuppressants with significant interaction with cisplatin are not eligible
  • Patients with known brain metastases are excluded
  • Patients who received prior systemic chemotherapy for the current cancer are excluded (prior chemotherapy for a different cancer is allowed)
  • Patients with definitive clinical or radiographic evidence of distant metastasis or adenopathy below the clavicles are not eligible

Applicable Disease Sites Esophagus; Head and Neck; Melanoma/Skin cancer; Thyroid

Therapies Involved Cytotoxic Chemotherapy; Radiotherapy

Drugs Involved VX-970 (M6620); cis-diamminedichloroplatinum (cisplatin); cisplatin; platinol (cisplatin); platinum (cisplatin)

Status Open

Participating Institutions UW Hospital and Clinics