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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John Stoddard Cancer Center at Iowa Methodist Medical Center
• Treatments: Ganciclovir; Ganciclovir triphosphate

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