NCT00055705CompletedPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Locations
- 1
Study Overview
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).
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •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
- •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
- •Cardiovascular
- •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
- +39 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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