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PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer Clinical research trials and PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer. PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer  PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
For Condition: Gastrointestinal Cancer,thorax and respiratory cancer,unclassified and other cancer,female reproductive cancer,Endocrine Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 recurrentovarian epithelial, fallopian tube, primaryperitoneal, colorectal, or other cancer found primarily within the peritoneal cavity.
Details: 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. - 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). - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidSpriggs, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting David Spriggs 212-639-2203
Additional Information:
Study ID Numbers: CDR0000270801; NCI-1617,MSKCC-02080
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055705
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5. PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
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PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
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