- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005025
Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating women who have refractory or relapsed ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the efficacy and safety of in vivo gene therapy with herpes simplex thymidine kinase (HSVtk) vector producer cells (VPC) followed by ganciclovir in women with refractory or relapsed ovarian epithelial adenocarcinoma, fallopian tube cancer, or peritoneal cancer.
- Determine any development of systemic immunity to this regimen or tumor in these patients.
- Determine the toxic effects of intraperitoneal HSVtk VPC in these patients.
OUTLINE: All patients receive an intraperitoneal catheter prior to infusion.
Patients receive herpes simplex thymidine kinase (HSVtk) vector producer cells (VPC) IP over 15-60 minutes on day 0, followed by ganciclovir IV 2 times daily on days 28-41. Treatment repeats for up to 3 courses in patients with stable or responsive disease.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 14-20 patients will be accrued for this study within 18-24 months.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Iowa
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Des Moines, Iowa, United States, 50309
- Human Gene Therapy Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed, refractory or relapsed, ovarian epithelial adenocarcinoma, fallopian tube cancer, or extraovarian peritoneal cancer for which no curative therapy exists
- Must have tissue available from tumor biopsy to grow tumor cells ex vivo
- Must have failed standard therapy with both a platinum agent (cisplatin or carboplatin) and paclitaxel
- Site of disease must be less than 5 cm in greatest diameter
- Evaluable disease by CT scan, physical exam, or laparoscopy
No significant peritoneal fibrosis either from disease or prior surgery
- Surgical lysis of adhesions allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 2,000/mm3
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 50,000/mm3
- Hemoglobin at least 8.5 g/dL (without transfusion)
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT or SGPT no greater than 4 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 4 times ULN
- Hepatitis B surface antigen test required prior to study if transaminases greater than 2.0 times ULN
- No hepatitis B surface antigen
- Amylase normal
- PT and PTT normal
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No cardiac dysfunction by history and exam
- No ischemic heart disease that may be considered anesthetic or operative risk
Pulmonary:
- No lung disease that may be considered anesthetic or operative risk
Other:
- HIV negative
- Not pregnant or nursing
- No acute viral, bacterial, or fungal infection requiring medication within 14 days prior to study
- No patient with greater than 2 L of ascites at the time of intraperitoneal infusion
- No underlying condition that would preclude compliance
- No allergies to study reagent
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- No concurrent high dose vitamin regimens
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Charles Joseph Link, MD, John Stoddard Cancer Center at Iowa Methodist Medical Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Ganciclovir
- Ganciclovir triphosphate
Other Study ID Numbers
- CDR0000067546
- HGTRI-0105
- NCI-V00-1584
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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