Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial
Official title:
A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma
Phase I trial to study the effectiveness of intratumoral (in the tumor) PV701 in treating patients who have advanced or recurrent unresectable squamous cell carcinoma (cancer) of the head and neck. Vaccines made from a specially-modified virus such as PV701 may make the body build an immune response to kill tumor cells while leaving normal cells undamaged. Injecting PV701 directly into the tumor may cause a stronger immune response and kill more tumor cells
OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) of PV701 administered by direct intratumoral
injection in patients with advanced or recurrent unresectable squamous cell carcinoma of the
head and neck.
II. Determine the toxicity of intratumoral PV701 in these patients. III. Determine response
rate and time to progression at the injection site in patients treated with this drug.
OUTLINE: This is a dose-escalation study. Patients receive intratumoral PV701 once weekly
for 3 weeks. Courses repeat every 6 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of PV701 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
determined, at least 6 evaluable patients are treated at that dose.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 6-10
months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01469429 -
Phase 1b Food Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer.
|
Phase 1/Phase 2 | |
Completed |
NCT01155609 -
L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer
|
N/A | |
Completed |
NCT00049283 -
Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
|
Phase 1 | |
Completed |
NCT01044433 -
Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck
|
Phase 2 | |
Completed |
NCT00407810 -
Cetuximab and Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT00098631 -
Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT00096512 -
S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT00055770 -
Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT01249443 -
Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection
|
Phase 1 | |
Completed |
NCT01637194 -
Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer
|
Phase 1 | |
Completed |
NCT00033618 -
Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck
|
Phase 2 | |
Withdrawn |
NCT01674374 -
Botanical Therapy in Treating Mucositis in Patients With Head and Neck Cancer Who Have Undergone Chemoradiation Therapy
|
Phase 2 | |
Completed |
NCT01816984 -
PI3K Inhibitor BKM120 and Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT01528137 -
Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer
|
Phase 1 | |
Terminated |
NCT02177838 -
Cetuximab and Radiation Therapy in Treating Patients With Stage III-IV Head and Neck Cancer
|
N/A | |
Completed |
NCT00114283 -
Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT00055913 -
Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT01682031 -
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
|
Phase 2 | |
Completed |
NCT00492089 -
Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer
|
Phase 2 | |
Completed |
NCT00410826 -
Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer
|
Phase 2 |