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Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer Clinical research trials and Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer. Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer clinical trial. Subjects frequently get the best healthcare possible for their Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer  Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer
Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer
For Condition: recurrent ovarian epithelial cancer,stage 4 ovarian epithelial cancer,peritoneal cavity cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Simmons Cancer Center
Synopsis: RATIONALE: Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. PURPOSE: Phase I trial to study the effectiveness of gene therapy using the p53 gene in treating patients with advanced recurrent or persistent ovarian cancer or primary peritoneal cavity cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of intraperitoneal adenoviral p53 gene therapy in patients with advanced, recurrent, or persistent ovarian carcinoma. II. Evaluate the vector pharmacokinetics and biologic efficacy of gene transfer, gene expression, and cell death in these patients. III. Determine the immunologic response to therapy in these patients. PROTOCOL OUTLINE: This is a dose escalation study of adenoviral p53 gene therapy. Patients undergo removal of ascites, if present, from the peritoneal cavity followed by a bolus infusion of adenovirus p53 once a week for 3 consecutive weeks, followed by a 2 week rest. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience palliative results with at least stable disease may continue treatment weekly without the rest period. Cohorts of 3-6 patients are treated at each level of adenovirus p53. The maximum tolerated dose is defined as the dose level below that at which 2 of 6 patients experience dose limiting toxicity. Patients who receive the MTD without unacceptable toxicity may continue to receive treatment on a weekly basis. PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued over 16-18 months for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed invasive ovarian epithelial carcinoma or primary peritoneal carcinoma at time of initial laparotomy - No histologically confirmed noninvasive ovarian malignancy or low malignant potential tumor or carcinomatosis from other nonovarian or peritoneal sites - At least three courses of first-line combination chemotherapy (platinum and paclitaxel) with either persistent or recurrent disease; If no treatment with first-line paclitaxel, salvage paclitaxel failure must be documented prior to eligibility - Ascites that is cytologically positive for adenocarcinoma or gross evidence of recurrent disease with ascites, or gross recurrent disease with abdominopelvic washing cytologically positive for adenocarcinoma - Adequate peritoneal distribution by Technetium 99 scan --Prior/Concurrent Therapy-- - Biologic therapy: No prior viral based gene therapy treatments or p53 directed vaccines; No other prior gene therapy - Chemotherapy: See Disease Characteristics; At least 4 weeks since chemotherapy; No concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since radiotherapy; No concurrent radiotherapy - Surgery: At least 4 weeks since surgery, including surgery for a perforated bowel, bowel anastamosis, colostomy, or ileostomy --Patient Characteristics-- - Age: 18 and over - Life expectancy: Greater than 12 weeks - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT/SGPT no greater than 2.5 times normal; No active hepatitis or chronic liver failure - Renal: Creatinine no greater than 2 mg/dL - Other: Not HIV positive; No concurrent immunosuppressive disorders; No active systemic infections or active peritonitis; Geographically available for follow-up; Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CarolynMuller, Study Chair, Simmons Cancer Center
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Additional Information:
Study ID Numbers: CDR0000066481; UTSMC-089733300,NCI-T97-0096
Study Start Date: June 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003450
Other Peritoneal Cavity Cancer Studies:
1. Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
2. Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
3. Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
4. Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
5. Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Refractory or Recurrent Ovarian Cancer
Related Studies:
Other peritoneal cavity cancer Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer
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