NCT00055705

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2003

Completed
Last Updated

April 26, 2011

Status Verified

August 1, 2004

First QC Date

March 6, 2003

Last Update Submit

April 23, 2011

Conditions

Cancer

Keywords

recurrent ovarian epithelial cancerstage IV ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancerrecurrent colon cancerstage IV colon cancerovarian sarcomarecurrent ovarian germ cell tumorstage IV ovarian germ cell tumorrecurrent endometrial carcinomastage IV endometrial carcinomarecurrent uterine sarcomastage IV uterine sarcomaovarian stromal cancerrecurrent rectal cancerstage IV rectal cancermetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorgastrointestinal stromal tumoradvanced malignant mesotheliomarecurrent malignant mesotheliomarecurrent gastric cancerstage IV gastric cancercarcinoma of the appendixsmall intestine adenocarcinomasmall intestine leiomyosarcomasmall intestine lymphomarecurrent small intestine cancerrecurrent gallbladder cancerunresectable gallbladder canceradvanced adult primary liver cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancer

Interventions

PV701BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

NeoplasmsCarcinoma, Ovarian EpithelialFallopian Tube NeoplasmsColonic NeoplasmsEndometrial NeoplasmsRectal NeoplasmsGastrointestinal Stromal TumorsMesothelioma, MalignantStomach NeoplasmsAppendiceal NeoplasmsGallbladder NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesUterine NeoplasmsUterine DiseasesRectal DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueMesotheliomaAdenomaNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsPleural NeoplasmsLung DiseasesRespiratory Tract DiseasesStomach DiseasesCecal NeoplasmsCecal DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesAdenocarcinomaLiver NeoplasmsLiver Diseases

Study Officials

  • David R. Spriggs, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2003

First Posted

March 7, 2003

Study Start

January 1, 2003

Last Updated

April 26, 2011

Record last verified: 2004-08

Locations

US(1)