Recurrent Fallopian Tube CarcinomaPhase 1NCT00602277
Viral Therapy in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Did Not Respond to Platinum Chemotherapy
A Phase 1 study testing Laboratory Biomarker Analysis and Wild-type Reovirus in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I/II trial is studying the side effects and best dose of viral therapy in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that did not respond to platinum chemotherapy (phase II closed as of 1/7/2011). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis and Wild-type Reovirus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
- Recurrent disease after platinum-based chemotherapy
- Must have experienced disease persistence during primary platinum-based therapy or recurrence within 12 months after completion of platinum-based chemotherapy ("platinum-refractory" or "platinum-resistant" disease)
- A patient receiving a second course of platinum-based chemotherapy for platinum-sensitive disease who then develops persistence or recurrence within 12 months is considered eligible for this trial
- Must have measurable disease by RECIST criteria (phase II) (phase II closed as of 1/7/2011)
- Must have received ≥ 1 prior platinum-based cytotoxic chemotherapy regimen (for primary disease) containing carboplatin, cisplatin, or other organoplatinum compound
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- Initial treatment may have included any of the following:
- High-dose therapy
- Consolidation therapy
- Intraperitoneal (IP) therapy
- Extended therapy administered after surgical or nonsurgical assessment
- One additional non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors) for recurrent or persistent disease allowed
- Patients may have received hormonal therapy for management of disease (e.g., SERMs, aromatase inhibitors, progestins, and GnRH agonists)
- No loculated ascites for which IP distribution of virus is not expected to be feasible
- No known brain metastases
- GOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
- Life expectancy > 12 weeks
- Leukocytes ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Hemoglobin ≥ 10 g/dL
- Platelets ≥ 100,000/mcL
- Total bilirubin normal
- AST/ALT ≤ 2.5 times upper limit of normal
- Creatinine normal
- Ejection fraction > 50% by echocardiogram or MUGA
- Cardiac enzymes normal
- Not pregnant or nursing
- Fertile patients must use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
- Must be able to avoid direct contact with pregnant or nursing women, infants, or immunocompromised individuals while on study and for ≥ 3 weeks following the last dose of study agent administration
- Cardiac conduction abnormalities (e.g., bundle branch block, heart block) are allowed if their cardiac status has been stable for 6 months before study entry
- At least 4 weeks since most recent cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- Recovered from adverse events due to agents administered more than 4 weeks earlier
- No prior radiotherapy to the abdomen or pelvis
- No other concurrent investigational agents
- No investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy
Who cannot join
- Patients in whom insertion of an IP catheter is not feasible due to surgical contraindications or abdominal and pelvic adhesions
- Known HIV infection or hepatitis B or C
- Clinically significant cardiac disease (New York Heart Association class III or IV cardiac disease) including any of the following:
- Pre-existing arrhythmia
- Uncontrolled angina pectoris
- Myocardial infarction 1 year prior to study entry
Show all 12Show fewer
- Compromised left ventricular ejection fraction ≥ grade 2 by MUGA or echocardiogram
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- Chronic oral steroids at an equivalent dose of prednisone 5 mg daily
- Inhaled steroids allowed
- Patients on immunosuppressive therapy
- Concurrent routine prophylactic use of growth factor (filgrastim [G-CSF] or sargramostim [GM-CSF])
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: A Phase 1 Study of Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) (NSC 729968) in Patients With Ovarian, Primary Peritoneal and Fallopian Tube Carcinoma
This phase I/II trial is studying the side effects and best dose of viral therapy in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that did not respond to platinum chemotherapy (phase II closed as of 1/7/2011). Viral therapy may be able to kill tumor cells without damaging normal cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the safety and tolerability of intravenous (IV) and intraperitoneal (IP) administration of wild-type reovirus (REOLYSIN®).
II. Determine the maximum tolerated dose of IP REOLYSIN® when used with a fixed dose of IV REOLYSIN®.
III. Determine the objective response rate (complete response and partial response per Response Evaluation Criteria in Solid Tumors [RECIST] criteria) of treatment with IV and IP REOLYSIN® in patients with recurrent, platinum-refractory ovarian epithelial, peritoneal, or fallopian tube carcinoma. (Phase II) (phase II closed as of 1/7/2011).
SECONDARY OBJECTIVES:
- To identify viral replication in tumor following IV reovirus. II. To identify anti-reovirus antibodies in patients being treated with IV and IP REOLYSIN® therapy.
III. To identify viral replication in the abdominal washings of patients undergoing IV and IP REOLYSIN® therapy.
IV. To correlate response to therapy with Ras oncogene status. V. To evaluate double-stranded RNA-activated protein kinase activity in tumors. VI. To correlate molecular predictors of response to REOLYSIN® therapy.
OUTLINE: This is a phase I, dose-escalation study of intraperitoneal (IP) wild-type reovirus when administered with fixed dose IV wild-type reovirus.
PHASE I: Patients receive wild-type reovirus IV over 60 minutes on days 1-5 in course 1, followed by insertion of an IP access port. Beginning in course 2, patients receive wild-type reovirus IV over 60 minutes on days 1-5 and wild-type reovirus IP over 10 minutes on days 1 and 2*. Treatment with IV and IP wild-type reovirus repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients undergo IP access port insertion before beginning treatment. Patients receive wild-type reovirus IV over 60 minutes on days 1-5 and IP (at the maximum tolerated dose determined in phase I) over 10 minutes on days 1 and 2*. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity (phase II closed as of 1/7/2011). NOTE: *Patients receive IP wild-type reovirus on days 2 and 3 in course 3.
Prior to each IP wild-type reovirus administration, normal saline is administered through the IP catheter and withdrawn for correlative studies in courses 2 and 3 (phase I) or courses 1 and 2 (phase II). Patients also undergo a CT-guided percutaneous tumor biopsy on day 2 of course 3 (phase I or II). Samples are analyzed by immunohistochemistry, RT-PCR, and electron microscopy for the relevant molecular effects of wild-type reovirus on tumor and normal tissue.
After completion of study treatment, patients are followed for up to 12 weeks.
- Conditions
- Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Being tested
- Laboratory Biomarker Analysis, Wild-type Reovirus
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Wild-type ReovirusBiological
Also called Reolysin
| Study group | Role | What they receive |
|---|---|---|
| Treatment (viral therapy) | Experimental | Patients receive wild-type reovirus IV over 60 minutes on days 1-5 in course 1, followed by insertion of an IP access port. Beginning in course 2, patients receive wild-type reovirus IV over 60 minutes on days 1-5 and wild-type reovirus IP over 10 minutes on days 1 and 2*. Treatment with IV and IP wild-type reovirus repeats every 28 days in the absence of disease progression or unacceptable toxicity. (phase II closed as of 1/7/2011). NOTE: *Patients receive IP wild-type reovirus on days 2 and 3 in course 3. Receives: Other: Laboratory Biomarker Analysis; Biological: Wild-type Reovirus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerable dose of intraperitoneal (IP) wild-type reovirus when administered with fixed dose IV wild-type reovirus (phase I)
Dose-limiting toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v. 4
Measured: At each dose level, assessed up to 5 dose levels
Objective response (partial response and complete response)
Response will be evaluated using the new international criteria proposed by RECIST Committee.
Measured: Every 8 weeks during treatment and assessed up to 12 weeks after completion of treatment
Secondary outcomes (1)
Association of Ras oncogene and molecular markers with objective response
Secondary endpoints are generally descriptive
Measured: During courses 1 and 2, and prior to course 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Fallopian Tube CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Cohn, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602277
- Sponsor's protocol ID
- NCI-2009-00234
- Other IDs
- NCI-2009-00234, CDR0000584038, OSU-07022, 2007C0028, 07022, 7853, P30CA016058, U01CA076576
- Status last verified
- Aug 2016
- First submitted
- 19 Jan 2008
- Last updated
- 8 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) (NSC 729968) in Patients With Ovarian, Primary Peritoneal and Fallopian Tube Carcinoma
- ClinicalTrials.gov ID
- NCT00602277
- Acronym / sponsor ID
- NCI-2009-00234
- Conditions
- Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2008
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Jan 2008 (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.
This phase I/II trial is studying the side effects and best dose of viral therapy in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that did not respond to platinum chemotherapy (phase II closed as of 1/7/2011). Viral therapy may be able to kill tumor cells without damaging normal cells.
Detailed description
PRIMARY OBJECTIVES:
- Determine the safety and tolerability of intravenous (IV) and intraperitoneal (IP) administration of wild-type reovirus (REOLYSIN®).
II. Determine the maximum tolerated dose of IP REOLYSIN® when used with a fixed dose of IV REOLYSIN®.
III. Determine the objective response rate (complete response and partial response per Response Evaluation Criteria in Solid Tumors [RECIST] criteria) of treatment with IV and IP REOLYSIN® in patients with recurrent, platinum-refractory ovarian epithelial, peritoneal, or fallopian tube carcinoma. (Phase II) (phase II closed as of 1/7/2011).
SECONDARY OBJECTIVES:
- To identify viral replication in tumor following IV reovirus. II. To identify anti-reovirus antibodies in patients being treated with IV and IP REOLYSIN® therapy.
III. To identify viral replication in the abdominal washings of patients undergoing IV and IP REOLYSIN® therapy.
IV. To correlate response to therapy with Ras oncogene status. V. To evaluate double-stranded RNA-activated protein kinase activity in tumors. VI. To correlate molecular predictors of response to REOLYSIN® therapy.
OUTLINE: This is a phase I, dose-escalation study of intraperitoneal (IP) wild-type reovirus when administered with fixed dose IV wild-type reovirus.
PHASE I: Patients receive wild-type reovirus IV over 60 minutes on days 1-5 in course 1, followed by insertion of an IP access port. Beginning in course 2, patients receive wild-type reovirus IV over 60 minutes on days 1-5 and wild-type reovirus IP over 10 minutes on days 1 and 2*. Treatment with IV and IP wild-type reovirus repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients undergo IP access port insertion before beginning treatment. Patients receive wild-type reovirus IV over 60 minutes on days 1-5 and IP (at the maximum tolerated dose determined in phase I) over 10 minutes on days 1 and 2*. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity (phase II closed as of 1/7/2011). NOTE: *Patients receive IP wild-type reovirus on days 2 and 3 in course 3.
Prior to each IP wild-type reovirus administration, normal saline is administered through the IP catheter and withdrawn for correlative studies in courses 2 and 3 (phase I) or courses 1 and 2 (phase II). Patients also undergo a CT-guided percutaneous tumor biopsy on day 2 of course 3 (phase I or II). Samples are analyzed by immunohistochemistry, RT-PCR, and electron microscopy for the relevant molecular effects of wild-type reovirus on tumor and normal tissue.
After completion of study treatment, patients are followed for up to 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (viral therapy) | Experimental | Other: Laboratory Biomarker Analysis, Biological: Wild-type ReovirusPatients receive wild-type reovirus IV over 60 minutes on days 1-5 in course 1, followed by insertion of an IP access port. Beginning in course 2, patients receive wild-type reovirus IV over 60 minutes on days 1-5 and wild-type reovirus IP over 10 minutes on days 1 and 2*. Treatment with IV and IP wild-type reovirus repeats every 28 days in the absence of disease progression or unacceptable toxicity. (phase II closed as of 1/7/2011). NOTE: *Patients receive IP wild-type reovirus on days 2 and 3 in course 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
- Recurrent disease after platinum-based chemotherapy
- Must have measurable disease by RECIST criteria (phase II) (phase II closed as of 1/7/2011)
- Must have received ≥ 1 prior platinum-based cytotoxic chemotherapy regimen (for primary disease) containing carboplatin, cisplatin, or other organoplatinum compound
- Patients may have received hormonal therapy for management of disease (e.g., SERMs, aromatase inhibitors, progestins, and GnRH agonists)
Key exclusion criteria (12 listed)
- Patients in whom insertion of an IP catheter is not feasible due to surgical contraindications or abdominal and pelvic adhesions
- Known HIV infection or hepatitis B or C
- Clinically significant cardiac disease (New York Heart Association class III or IV cardiac disease) including any of the following:
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- Chronic oral steroids at an equivalent dose of prednisone 5 mg daily
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (viral therapy) |
| Wild-type ReovirusAlso: Reolysin | Biological | Treatment (viral therapy) |
Primary outcome
Maximum tolerable dose of intraperitoneal (IP) wild-type reovirus when administered with fixed dose IV wild-type reovirus (phase I)
Time frame: At each dose level, assessed up to 5 dose levels
Dose-limiting toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v. 4
Objective response (partial response and complete response)
Time frame: Every 8 weeks during treatment and assessed up to 12 weeks after completion of treatment
Response will be evaluated using the new international criteria proposed by RECIST Committee.
1 secondary outcome
Association of Ras oncogene and molecular markers with objective response
Time frame: During courses 1 and 2, and prior to course 3
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 8 Aug 2016.
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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.
David Cohn principal investigator
Ohio State University Comprehensive Cancer Center
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 Laboratory Biomarker Analysis and Wild-type Reovirus in people with Recurrent Fallopian Tube Carcinoma and Recurrent Ovarian Carcinoma, run by National Cancer Institute (NCI) 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 35 inclusion and 12 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 8 Aug 2016. 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?
Maximum tolerable dose of intraperitoneal (IP) wild-type reovirus when administered with fixed dose IV wild-type reovirus (phase I) (time frame: At each dose level, assessed up to 5 dose levels). The study lists 2 primary outcomes in all. 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 8 Aug 2016.