Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

John Stoddard Cancer Center at Iowa Methodist Medical Center

Status and phase

Unknown

Phase 2

Conditions

Primary Peritoneal Cavity Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: ganciclovir

Biological: herpes simplex thymidine kinase

Study type

Interventional

Funder types

Other

Identifiers

NCT00005025

CDR0000067546

HGTRI-0105

NCI-V00-1584

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: