Fallopian Tube CancerPhase 2NCT00005025
Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
A Phase 2 study testing herpes simplex thymidine kinase and ganciclovir in people with Fallopian Tube Cancer and Ovarian Cancer, run by John Stoddard Cancer Center at Iowa Methodist Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- herpes simplex thymidine kinase and ganciclovir
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Gene Therapy Research Institute
Des Moines, Iowa, 50309
About this study
Official title: A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
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.
Read the detailed 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.
- Being tested
- herpes simplex thymidine kinase, ganciclovir
- Keywords
- recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herpes simplex thymidine kinaseBiological
ganciclovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2003 (estimated)
- Study startJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Charles Joseph Link, MD, Study chair, John Stoddard Cancer Center at Iowa Methodist Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005025
- Sponsor's protocol ID
- CDR0000067546
- Other IDs
- HGTRI-0105, NCI-V00-1584
- Status last verified
- Mar 2003
- First submitted
- 6 Apr 2000
- Last updated
- 6 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00005025
- Acronym / sponsor ID
- CDR0000067546
- Keywords
- recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- John Stoddard Cancer Center at Iowa Methodist Medical CenterUniversity, hospital or other
- Study start
- Jun 2000
- First posted
- 5 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| herpes simplex thymidine kinase | Biological | – |
| ganciclovir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Joseph Link, MD study chair
John Stoddard Cancer Center at Iowa Methodist Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing herpes simplex thymidine kinase and ganciclovir in people with Fallopian Tube Cancer and Ovarian Cancer, run by John Stoddard Cancer Center at Iowa Methodist Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.