Trial | NCT00005025  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    None
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.
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 Started
Jun 30
2000
Last Update
Nov 06
2013
Estimate

Biological herpes simplex thymidine kinase

Drug ganciclovir

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
No Results Posted