Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Laryngeal Diseases

Laryngeal Neoplasms

Oropharyngeal Neoplasms

Salivary Gland Neoplasms

Paranasal Sinus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Respiratory Tract Neoplasms

Pharyngeal Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Mouth Neoplasms

Mouth Diseases

Salivary Gland Diseases

Nasopharyngeal Neoplasms

Nasopharyngeal Diseases

Nose Neoplasms

Nose Diseases

Paranasal Sinus Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

Oral Cancer

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.

PV701

David Gustin

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.

Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck

A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma

Descriptive statistics will be generated for each group.

National Cancer Institute (NCI)

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Immune System Diseases

Adenocarcinoma

Stomach Neoplasms

Sarcoma

Carcinoma, Ovarian Epithelial

Lymphoma

Gastrointestinal Stromal Tumors

Liver Neoplasms

Mesothelioma

Mesothelioma, Malignant

Carcinoid Tumor

Leiomyosarcoma

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Lymphosarcoma

Primary Liver Cancer

Gallbladder Cancer

Germ Cells Tumors

Fallopian Tube Cancer

Malignant Mesothelioma

Small Intestinal Adenocarcinoma

Ovarian Germ Cell Tumor

Uterine Sarcoma

Small Intestine Cancer

Hematinics

All Drugs and Chemicals

Herbal and Botanical

Liver Extracts

Cola

David R. Spriggs, MD

RATIONALE: PV701 may be able to kill tumor cells while leaving normal cells undamaged.

PURPOSE: Phase I trial to study the effectiveness of PV701 in treating patients who have advanced or recurrent ovarian epithelial, fallopian tube, primary peritoneal, colorectal, or other cancer found primarily within the peritoneal cavity.

OBJECTIVES:

* Determine the dose-limiting toxicity and maximum tolerated dose of intraperitoneal PV701 after desensitization in patients with advanced or recurrent malignancy largely confined to the peritoneal cavity these patients.
* Determine the optimal desensitization dose of intravenous PV701 in these patients.
* Determine the safety of this drug, in terms of cumulative toxicity, in these patients.
* Determine, preliminarily, the antitumor activity of this drug in these patients.
* Determine the presence and duration of viral shedding, viremia, and immunogenicity of this drug.

OUTLINE: This is an open-label, dose-escalation study comprising 2 different treatment schedules.

* Schedule I (optimal desensitization dose): Patients receive PV701 IV over 30 minutes on day 1 followed by intraperitoneal (IP) PV701 on days 4, 7, and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of PV701 IV and IP until the optimal desensitization dose (ODD) is determined. The ODD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity (DLT).

* Schedule II (maximum tolerated dose):Patients receive the same regimen as in schedule I using PV701 IV at the ODD.

Cohorts of 3-6 patients receive escalating doses of PV701 IP until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT.

PROJECTED ACCRUAL: A total of 3-50 patients will be accrued for this study within 10-17 months.

PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer

A Phase I Clinical Trial To Assess The Safety And Efficacy Of Intraperitoneal PV701 Administrations In Patients With Advanced Or Recurrent Malignancy Largely Confined To The Peritoneal Cavity

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck	NCT00081211	Recurrent Saliv... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Recurrent Squam... Salivary Gland ... Stage III Saliv... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage III Squam... Stage IV Saliva... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo... Stage IV Squamo...	PV701	18 Years -	National Cancer Institute (NCI)
PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer	NCT00055705	Cancer	PV701	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for pv701

Every month we try and update this database with for pv701 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pv701

Every month we try and update this database with for pv701 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pv701 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.