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PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055705
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : April 26, 2011
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Cancer Biological: PV701 Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2003

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 3 months


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 9 g/dL


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 1.5 times ULN
  • No uncontrolled hepatic dysfunction
  • No active hepatitis B or C


  • See Disease Characteristics
  • Creatinine no greater than 1.6 mg/dL AND/OR
  • Creatinine clearance at least 50 mL/min
  • No uncontrolled renal dysfunction


  • No uncontrolled cardiovascular dysfunction
  • No myocardial infarction within the past 6 months
  • No life-threatening arrhythmias within the past 6 months


  • See Disease Characteristics
  • No uncontrolled pulmonary dysfunction
  • No pulmonary atelectasis (lobar)
  • No pulmonary infiltrates (lobar)
  • No pulmonary consolidation (lobar or segmental)
  • No baseline grade II dyspnea


  • See Disease Characteristics
  • No uncontrolled adrenal dysfunction
  • No known adrenal insufficiency


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled gastrointestinal dysfunction
  • No neurological dysfunction
  • No serious medical or psychological condition that would preclude study participation or increase the risk of adverse effects of the study treatment
  • No history of serious immunodeficiency
  • No active uncontrolled bacterial infection (including asymptomatic urinary tract infection)
  • No contraindication to intraperitoneal therapy including the following:

    • Intra-abdominal infection
    • Dense widespread adhesions
    • Peritonitis
    • Periumbilical infection
    • Bowel obstruction
    • Ileostomy
  • No hypersensitivity to eggs
  • No continued contact with live birds (e.g., poultry farmers, veterinarians, laboratory technicians, pet store owners, breeders)


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • No more than 3 prior cytotoxic chemotherapy regimens
  • More than 30 days since prior chemotherapy

Endocrine therapy

  • More than 14 days since prior systemic corticosteroids


  • More than 30 days since prior radiotherapy


  • See Disease Characteristics
  • No prior complete or partial lobectomy with removal of lung tissue at least segmental size
  • No prior organ allograft


  • Recovered from prior therapy
  • More than 14 days since prior antiviral medication
  • More than 4 weeks since prior immunosuppressive drugs
  • No other concurrent investigational drugs
  • No concurrent chronic immunosuppressive drugs (e.g., cyclosporine)
  • No vaccination for influenza within 48 hours of study drug administration
  • No concurrent hypoglycemic agents
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055705

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: David R. Spriggs, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00055705    
Other Study ID Numbers: CDR0000270801
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: August 2004
Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
recurrent colon cancer
stage IV colon cancer
ovarian sarcoma
recurrent ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent endometrial carcinoma
stage IV endometrial carcinoma
recurrent uterine sarcoma
stage IV uterine sarcoma
ovarian stromal cancer
recurrent rectal cancer
stage IV rectal cancer
metastatic gastrointestinal carcinoid tumor
recurrent gastrointestinal carcinoid tumor
gastrointestinal stromal tumor
advanced malignant mesothelioma
recurrent malignant mesothelioma
recurrent gastric cancer
stage IV gastric cancer
carcinoma of the appendix
small intestine adenocarcinoma
small intestine leiomyosarcoma
small intestine lymphoma
recurrent small intestine cancer
recurrent gallbladder cancer
unresectable gallbladder cancer