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Mesothelioma Clinical Trials

PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer

This study is currently recruiting patients.

Sponsored by

Memorial Sloan-Kettering Cancer Center
For more information:National Cancer Institute (NCI)

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 recurrentovarian epithelial, fallopian tube, primaryperitoneal, colorectal, or other cancer found primarily within the peritoneal cavity.

Condition Treatment or Intervention
Endocrine Cancer
female reproductive cancer
Gastrointestinal Cancer
thorax and respiratory cancer
unclassified and other cancer
 Drug: PV701
 Procedure: gene therapy

This is a Phase I test

  • In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Intraperitoneal PV701 in Patients With Advanced or Recurrent Malignancy Largely Confined to the Peritoneal Cavity

Further Study Details: 


  • 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.

  • 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).
  • 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both



  • Histological confirmation of 1 of the following:
  • Ovarian epithelial carcinoma
  • Fallopian tube cancer
  • Primary peritoneal cancer
  • Advanced colorectal carcinoma
  • Other malignancy confined to the peritoneal cavity or peritoneal surfaces
  • No lesion greater than 2 cm in greatest diameter based on surgical re-assessment
  • Low burden of tumor in the abdominal or pelvic cavities and no clinically significant ascites
  • Received potentially effective therapy when available (e.g., platinum/taxane for ovarian cancer, fluoropyrimidine-based therapy for colorectal cancer)
  • No concurrent hematological malignancy (e.g., chronic lymphocytic leukemia or non-Hodgkin's lymphoma)
  • No bilateral adrenal metastases
  • No adrenal metastases in the remaining adrenal gland after adrenalectomy (including radical nephrectomy)
  • No lung tumors 5 cm or more
  • No pleural effusions (at least 25% of hemithorax) by radiography
  • No CNS metastases by CT scan or MRI  

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