Trial record 15 of 31 for:    "Li Fraumeni syndrome"

Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003450
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: June 2002
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Biological: Ad5CMV-p53 gene
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of Intraperitoneal Adenoviral p53 Gene Therapy in Patients With Advanced Recurrent or Persistent Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 20
Study Start Date: September 1998
Detailed Description:

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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003450

Locations
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Sponsors and Collaborators
Simmons Cancer Center
Investigators
Study Chair: Carolyn Y. Muller, MD University of New Mexico Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003450     History of Changes
Other Study ID Numbers: CDR0000066481, UTSMC-089733300, NCI-T97-0096
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014