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| ID | Type | Description | Link |
|---|---|---|---|
| HGTRI-0105 | |||
| NCI-V00-1584 |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| herpes simplex thymidine kinase | Biological | |||
| ganciclovir | Drug |
DISEASE CHARACTERISTICS:
Histologically confirmed, refractory or relapsed, ovarian epithelial adenocarcinoma, fallopian tube cancer, or extraovarian peritoneal cancer for which no curative therapy exists
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
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Joseph Link, MD | John Stoddard Cancer Center at Iowa Methodist Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Gene Therapy Research Institute | Des Moines | Iowa | 50309 | United States |
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| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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