Clinical trial · Interventional
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
NCT00055705CI-TRIAL-00004733completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PV701 | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.