PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer

Tracking Information
First Submitted Date ICMJE	March 6, 2003
First Posted Date ICMJE	March 7, 2003
Last Update Posted Date	April 26, 2011
Study Start Date ICMJE	January 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00055705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
Official Title ICMJE	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
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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Cancer
Intervention ICMJE	Biological: PV701
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE	Not Provided
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age; 18 and over Performance status; Karnofsky 70-100% Life expectancy; More than 3 months Hematopoietic; 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 Hepatic; 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 Renal; See Disease Characteristics; Creatinine no greater than 1.6 mg/dL AND/OR; Creatinine clearance at least 50 mL/min; No uncontrolled renal dysfunction Cardiovascular; No uncontrolled cardiovascular dysfunction; No myocardial infarction within the past 6 months; No life-threatening arrhythmias within the past 6 months Pulmonary; 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 Adrenal; See Disease Characteristics; No uncontrolled adrenal dysfunction; No known adrenal insufficiency Other; 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) PRIOR CONCURRENT THERAPY: Biologic therapy; Not specified Chemotherapy; 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 Radiotherapy; More than 30 days since prior radiotherapy Surgery; See Disease Characteristics; No prior complete or partial lobectomy with removal of lung tissue at least segmental size; No prior organ allograft Other; 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00055705
Other Study ID Numbers ICMJE	CDR0000270801; MSKCC-02080; NCI-1617
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Memorial Sloan Kettering Cancer Center
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Study Chair: David R. Spriggs, MD Memorial Sloan Kettering Cancer Center
PRS Account	National Cancer Institute (NCI)
Verification Date	August 2004
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP