Brief Title
Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
Official Title
A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
Brief Summary
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.
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 Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
herpes simplex thymidine kinase
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Start Date
June 2000
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Charles Joseph Link, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00005025
Organization ID
CDR0000067546
Secondary IDs
HGTRI-0105
Study Sponsor
John Stoddard Cancer Center at Iowa Methodist Medical Center
Study Sponsor
Charles Joseph Link, MD, Study Chair, John Stoddard Cancer Center at Iowa Methodist Medical Center
Verification Date
March 2003