Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: herpes simplex thymidine kinase Drug: ganciclovir |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer |
| Study Start Date: | June 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Iowa | |
| Human Gene Therapy Research Institute | |
| Des Moines, Iowa, United States, 50309 | |
| Study Chair: | Charles Joseph Link, MD | John Stoddard Cancer Center at Iowa Methodist Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00005025 History of Changes |
| Other Study ID Numbers: | CDR0000067546, HGTRI-0105, NCI-V00-1584 |
| Study First Received: | April 6, 2000 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013