Ovarian CancerPhase 1Ad5Delta24RGDNCT00562003
Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients
A Phase 1 study testing Tenckhoff Catheter placement and Ad5-delta24RGD in people with Ovarian Cancer and Primary Peritoneal Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the maximally tolerated dose and spectrum of toxicities encountered with intraperitoneal delivery of a RGD modified conditionally replicative adenovirus (Ad5-Delta 24RGD) in patients with recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer
- What is being tested?
- Tenckhoff Catheter placement and Ad5-delta24RGD
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2010
- Phase
- Phase 1
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically documented invasive epithelial ovarian or extra-ovarian adenocarcinoma
- Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional chemotherapy.Prior chemotherapy must have included a taxane/platinum based regimen
- Patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable
- Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months
- Patients must have adequate hematologic, renal, cardiac, pulmonary, coagulation, and hepatic function defined as:
- WBC> 3,000 ul
Show all 15Show fewer
- Granulocytes> 1,500 ul
- Platelets> 100,000
- Creatinine clearance (actual or calculated) >80 mg/dl or serum creatinine <2.0
- Serum transaminases <2.5x upper limits of normal
- Normal serum bilirubin
- PT/PTT/INR < 1.5 x institutional ULN
- Ejection fraction on echocardiogram > 55%
- O2 saturation > 92%
- Patients must be 19 years or older (as mandated by Alabama state law) and must have signed informed consent
Who cannot join
- Patients with epithelial ovarian tumors of low malignant potential (with or without invasive implants), with ovarian stromal tumors, or with germ cell tumors of the ovary are ineligible to participate in the study
- Patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study
- Patients who are pregnant or lactating are ineligible to participate in the study
- Patients with a GOG performance status of 3 or 4 are ineligible to participate in the study
- Patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or EF < 55%, pulmonary hypertension), active or chronic debilitating pulmonary disease (i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation < 92%), or coagulation disorders (i.e., bleeding disorders, on therapeutic anti-coagulants)
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology
Birmingham, Alabama, 35205
About this study
Official title: A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (Ad5-Delta 24 RGD)for Intraperitoneal Delivery in Ovarian and Extraovarian Cancer Patients (Infectivity Enhanced Virotherapy for Ovarian Cancer)
The primary purpose of this study is to determine the maximally tolerated dose and spectrum of toxicities encountered with intraperitoneal delivery of a RGD modified conditionally replicative adenovirus (Ad5-Delta 24RGD) in patients with recurrent ovarian cancer.
Secondary objectives :
- To determine the biologic effects encountered with intraperitoneal delivery of Ad5-Delta 24RGD in patients with recurrent ovarian cancer cells
- To determine immunologic response generated against Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
- To determine potential clinical activity of Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
- Conditions
- Ovarian Cancer, Primary Peritoneal Cancer
- Being tested
- Tenckhoff Catheter placement, Ad5-delta24RGD
- Keywords
- Ovarian cancer study
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenckhoff Catheter placementProcedure or surgery
'Tenckhoff catheter' will be placed into the abdominal cavity by a minor surgical procedure performed in the Radiology Department.
Ad5-delta24RGDDrug
Within two weeks before the start of the study, a physical exam, blood tests, removal of fluid from abdominal cavity through the catheter and a CT scan of abdomen and pelvis will be performed.
The procedure will involve receiving the Ad5-delta24RGD virus once a day for 3 days. The virus will be put into the abdominal cavity through a 'Tenckhoff catheter'.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD
Measured: 1 month
Secondary outcomes (1)
To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ronald D Alvarez, M.D., Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562003
- Sponsor's protocol ID
- F061005016 (UAB 0643)
- Other IDs
- UAB 0643
- Acronym
- Ad5Delta24RGD
- Status last verified
- Jan 2011
- First submitted
- 20 Nov 2007
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (Ad5-Delta 24 RGD)for Intraperitoneal Delivery in Ovarian and Extraovarian Cancer Patients (Infectivity Enhanced Virotherapy for Ovarian Cancer)
- ClinicalTrials.gov ID
- NCT00562003
- Acronym / sponsor ID
- Ad5Delta24RGD / F061005016 (UAB 0643)
- Conditions
- Ovarian Cancer, Primary Peritoneal Cancer
- Keywords
- Ovarian cancer study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Nov 2007 (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.
The primary purpose of this study is to determine the maximally tolerated dose and spectrum of toxicities encountered with intraperitoneal delivery of a RGD modified conditionally replicative adenovirus (Ad5-Delta 24RGD) in patients with recurrent ovarian cancer.
Secondary objectives :
- To determine the biologic effects encountered with intraperitoneal delivery of Ad5-Delta 24RGD in patients with recurrent ovarian cancer cells
- To determine immunologic response generated against Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
- To determine potential clinical activity of Ad5-Delta 24RGD when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have histologically documented invasive epithelial ovarian or extra-ovarian adenocarcinoma
- Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional chemotherapy.Prior chemotherapy must have included a taxane/platinum based regimen
- Patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable
- Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months
- Patients must have adequate hematologic, renal, cardiac, pulmonary, coagulation, and hepatic function defined as:
Key exclusion criteria (5 listed)
- Patients with epithelial ovarian tumors of low malignant potential (with or without invasive implants), with ovarian stromal tumors, or with germ cell tumors of the ovary are ineligible to participate in the study
- Patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study
- Patients who are pregnant or lactating are ineligible to participate in the study
- Patients with a GOG performance status of 3 or 4 are ineligible to participate in the study
- Patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or EF < 55%, pulmonary hypertension), active or chronic debilitating pulmonary disease (i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation < 92%), or coagulation disorders (i.e., bleeding disorders, on therapeutic anti-coagulants)
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 |
|---|---|---|
| Tenckhoff Catheter placement'Tenckhoff catheter' will be placed into the abdominal cavity by a minor surgical procedure performed in the Radiology Department. | Procedure or surgery | – |
| Ad5-delta24RGDWithin two weeks before the start of the study, a physical exam, blood tests, removal of fluid from abdominal cavity through the catheter and a CT scan of abdomen and pelvis will be performed. The procedure will involve receiving the Ad5-delta24RGD virus once a day for 3 days. The virus will be put into the abdominal cavity through a 'Tenckhoff catheter'. | Drug | – |
Primary outcome
To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD
Time frame: 1 month
1 secondary outcome
To determine biologic, immunologic, and anti-tumor effects of Ad5-delta24RGD
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
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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.
Ronald D Alvarez, M.D. principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenckhoff Catheter placement and Ad5-delta24RGD in people with Ovarian Cancer and Primary Peritoneal Cancer, run by University of Alabama at Birmingham 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?
The sponsor lists 15 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 26 Jan 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD (time frame: 1 month). It is what the study was designed to measure, not a finding.
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 26 Jan 2011.