Ovarian CancerPhase 1NCT00408590
Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer
A Phase 1 study testing carcinoembryonic antigen-expressing measles virus, oncolytic measles virus encoding thyroidal sodium iodide symporter and reverse transcriptase-polymerase chain reaction in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: A gene-modified virus may be able to kill tumor cells without damaging normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of an attenuated oncolytic measles virus therapy and oncolytic virus therapy in treating patients with progressive, recurrent, or refractory ovarian… Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- carcinoembryonic antigen-expressing measles virus, oncolytic measles virus encoding thyroidal sodium iodide symporter and reverse transcriptase-polymerase chain reaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2004to 7 Nov 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Must have persistent, recurrent or progressive ovarian cancer or primary peritoneal cancer after prior treatment with platinum and taxol compounds. Histologic confirmation of the original primary tumor is required. Prior bilateral oophorectomy is required.
- Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometroid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma NOS
- The following laboratory values obtained ≤7 days prior to registration:
- ANC ≥ 1500/μL
- PLT ≥ 100,000/μL
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- Total bilirubin ≤ upper normal limit
- AST ≤ 2 x ULN
- Creatinine ≤ 1.5 x ULN
- Hgb ≥ 9.0 g/dL
- Ability to provide informed consent.
- Willingness to return to Mayo Clinic Rochester for follow-up.
- Life expectancy ≥ 12 weeks.
- Must have anti-measles immunity as demonstrated by serum IgG anti-measles antibody levels of ≥ 20.0 EU/ml as determined by Enzyme Immunoassay (Diamedix, FL).
- Must have normal serum CEA levels (<5 mg/ml) both at the time of study entry and in any prior testing. (NOTE: Not applicable for the MV-NIS cohort.)
- Willingness to provide all biologic specimens as required by the protocol.
- Measurable disease by exam or CT scan, or, for patients with CA-125 elevation or with microscopic residual but without measurable disease on imaging, willingness to undergo laparoscopy for evaluation of treatment effect if no radiographic progression after 6 treatment cycles.
- CD4 count ≥200/μL or ≥15% of peripheral blood lymphocytes
Who cannot join
- Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary.
- Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy. Subjects will be excluded if this is their first relapse and they have recurred >6 mo from completion of primary (adjuvant) chemotherapy.
- ECOG performance status (PS) 3 or 4.
- Active infection ≤5 days prior to registration.
- History of tuberculosis or history of PPD positivity.
- History of other malignancy ≤5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix.
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- Any of the following prior therapies:
- Chemotherapy ≤ 3 weeks prior to study entry
- Immunotherapy ≤ 4 weeks prior to study entry
- Biologic therapy ≤ 4 weeks prior to study entry
- Extensive abdominal surgery if it includes enterotomy(ies) <3 weeks prior to study entry. This criterion does not apply to placement of the peritoneal port-a-cath or lysis of adhesions at the time of study entry.
- Any viral or gene therapy prior to study entry
- Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment.
- New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or SVT).
- Requiring blood product support.
- CNS metastases or seizure disorder.
- HIV-positive test result, or history of other immunodeficiency.
- History of organ transplantation.
- History of chronic hepatitis B or C.
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation).
- Any concurrent medications which could interfere with the trial.
- Intra-abdominal disease > 8 cm in diameter at the time of registration, intrahepatic disease, or disease beyond the abdominal cavity.
- Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids.
- Exposure to household contacts ≤15 months old or household contact with known immunodeficiency.
- Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
- Allergy to iodine. This does not include reactions to intravenous contrast materials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Trial of Intraperitoneal Administration of a) a CEA-Expressing Derivative, and b) a NIS-Expressing Derivative Manufactured From a Genetically Engineered Strain of Measles Virus in Patients With Recurrent Ovarian Cancer
RATIONALE: A gene-modified virus may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of an attenuated oncolytic measles virus therapy and oncolytic virus therapy in treating patients with progressive, recurrent, or refractory ovarian epithelial cancer or primary peritoneal cancer (measles virus vaccine therapy study closed as of 06/02/2008).
Read the detailed description
OBJECTIVES:
- Determine the safety and toxicity of recombinant carcinoembryonic antigen (CEA)-expressing measles virus (MV-CEA) and oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) in patients with progressive, recurrent, or refractory ovarian epithelial or primary peritoneal cavity cancer ( MV-CEA closed as of 06/02/2008).
- Determine the maximum-tolerated dose of MV-CEA and MV-NIS in these patients ( MV-CEA closed as of 06/02/2008).
- Characterize viral gene expression at each dose level as manifested by CEA titers in these patients.
- Assess viremia, viral replication, and measles virus shedding or persistence after study therapy.
- Determine humoral and cellular immune response to the injected virus in these patients.
- Assess, preliminarily, the antitumor efficacy of this therapy, by assessing CA-125 levels, radiographic response, and time to progression, in these patients.
- Determine the time course of viral gene expression and virus elimination and biodistribution of virally infected cells at various time points after infection with MV-NIS using single photon emission computed tomography (SPECT/CT) imaging.
- Assess viremia, viral replication, and measles virus shedding/persistence following intraperitoneal administration of MV-NIS.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant carcinoembryonic antigen-expressing measles virus (MV-CEA) or oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) intraperitoneally over 30 minutes on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity ( MV-CEA closed as of 06/02/2008).
Cohorts of 3-6 patients receive escalating doses of MV-CEA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity ( MV-CEA closed as of 06/02/2008).
Peripheral blood mononuclear cells are collected at baseline and periodically during and after treatment to assess viremia. Throat gargle and urine specimens are assessed periodically during course 1 for viral shedding by reverse transcriptase-polymerase chain reaction (RT-PCR). Peritoneal aspirate is tested at baseline and periodically during treatment for viral replication by RT-PCR, co-culture with Vero cells, and measles virus N-specific mRNA in situ hybridization.
Patients may undergo single photon emission computed tomography (SPECT/CT) imaging at baseline and periodically during study.
After completion of study therapy, patients are followed periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
- Conditions
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Being tested
- carcinoembryonic antigen-expressing measles virus, oncolytic measles virus encoding thyroidal sodium iodide symporter, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis
- Keywords
- ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, primary peritoneal cavity cancer, ovarian mixed epithelial carcinoma, ovarian mucinous cystadenocarcinoma, ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma, recurrent ovarian epithelial cancer, Brenner tumor
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Brenner Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carcinoembryonic antigen-expressing measles virusBiological
oncolytic measles virus encoding thyroidal sodium iodide symporterBiological
reverse transcriptase-polymerase chain reactionGenetic
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Biological: carcinoembryonic antigen-expressing measles virus; Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
If one patient experiences a Dose limiting Toxicity(DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose
Measured: up to 12 months after last treatment
Secondary outcomes (3)
Number of Responses (Complete and Partial, Stable and Progressive Disease)
Responses will be summarized separately for the MV-CEA virus and MV-NIS virus by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. CA125 levels and time to progression will also be summarized descriptively. Modified Response Evaluation Criteria in Solid Tumors(RECIST v1.0) criteria will be used. For target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter(LD) of target lesions; Progression (PD): As least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD
Measured: up to 12 months after last treatment
Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months)
CA-125 tests are measured in units per milliliter (U/mL) and taken every cycle (up to 6-28 day cycles) during treatment and every three months up to 12 months after treatment. The change in CA-125 is calculated as the baseline CA-125 value subtracted by the last recorded value of CA-125 (up to 18 months from baseline.
Measured: baseline and up to 18 months
Time to Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: up to 12 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study start19 Apr 2004
- Primary completionAug 2012
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Evanthia Galanis, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408590
- Sponsor's protocol ID
- CDR0000515008
- Other IDs
- P30CA015083, MC0117, 1260-03, NCI-2009-01199, P50CA136393
- Status last verified
- Jan 2024
- First submitted
- 6 Dec 2006
- Last updated
- 16 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Intraperitoneal Administration of a) a CEA-Expressing Derivative, and b) a NIS-Expressing Derivative Manufactured From a Genetically Engineered Strain of Measles Virus in Patients With Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00408590
- Acronym / sponsor ID
- CDR0000515008
- Conditions
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Keywords
- ovarian clear cell cystadenocarcinoma, ovarian endometrioid adenocarcinoma, primary peritoneal cavity cancer, ovarian mixed epithelial carcinoma, ovarian mucinous cystadenocarcinoma, ovarian serous cystadenocarcinoma, ovarian undifferentiated adenocarcinoma, recurrent ovarian epithelial cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Apr 2004 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 7 Dec 2006 (estimated)
- Results
- Posted 2 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: A gene-modified virus may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of an attenuated oncolytic measles virus therapy and oncolytic virus therapy in treating patients with progressive, recurrent, or refractory ovarian epithelial cancer or primary peritoneal cancer (measles virus vaccine therapy study closed as of 06/02/2008).
Detailed description
OBJECTIVES:
- Determine the safety and toxicity of recombinant carcinoembryonic antigen (CEA)-expressing measles virus (MV-CEA) and oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) in patients with progressive, recurrent, or refractory ovarian epithelial or primary peritoneal cavity cancer ( MV-CEA closed as of 06/02/2008).
- Determine the maximum-tolerated dose of MV-CEA and MV-NIS in these patients ( MV-CEA closed as of 06/02/2008).
- Characterize viral gene expression at each dose level as manifested by CEA titers in these patients.
- Assess viremia, viral replication, and measles virus shedding or persistence after study therapy.
- Determine humoral and cellular immune response to the injected virus in these patients.
- Assess, preliminarily, the antitumor efficacy of this therapy, by assessing CA-125 levels, radiographic response, and time to progression, in these patients.
- Determine the time course of viral gene expression and virus elimination and biodistribution of virally infected cells at various time points after infection with MV-NIS using single photon emission computed tomography (SPECT/CT) imaging.
- Assess viremia, viral replication, and measles virus shedding/persistence following intraperitoneal administration of MV-NIS.
OUTLINE: This is a dose-escalation study.
Patients receive recombinant carcinoembryonic antigen-expressing measles virus (MV-CEA) or oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) intraperitoneally over 30 minutes on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity ( MV-CEA closed as of 06/02/2008).
Cohorts of 3-6 patients receive escalating doses of MV-CEA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity ( MV-CEA closed as of 06/02/2008).
Peripheral blood mononuclear cells are collected at baseline and periodically during and after treatment to assess viremia. Throat gargle and urine specimens are assessed periodically during course 1 for viral shedding by reverse transcriptase-polymerase chain reaction (RT-PCR). Peritoneal aspirate is tested at baseline and periodically during treatment for viral replication by RT-PCR, co-culture with Vero cells, and measles virus N-specific mRNA in situ hybridization.
Patients may undergo single photon emission computed tomography (SPECT/CT) imaging at baseline and periodically during study.
After completion of study therapy, patients are followed periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Biological: carcinoembryonic antigen-expressing measles virus, Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter, Genetic: reverse transcriptase-polymerase chain reaction, Other: laboratory biomarker analysis |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years.
- Must have persistent, recurrent or progressive ovarian cancer or primary peritoneal cancer after prior treatment with platinum and taxol compounds. Histologic confirmation of the original primary tumor is required. Prior bilateral oophorectomy is required.
- Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometroid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma NOS
- The following laboratory values obtained ≤7 days prior to registration:
- Ability to provide informed consent.
Key exclusion criteria (26 listed)
- Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary.
- Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy. Subjects will be excluded if this is their first relapse and they have recurred >6 mo from completion of primary (adjuvant) chemotherapy.
- ECOG performance status (PS) 3 or 4.
- Active infection ≤5 days prior to registration.
- History of tuberculosis or history of PPD positivity.
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 |
|---|---|---|
| carcinoembryonic antigen-expressing measles virus | Biological | Experimental Arm |
| oncolytic measles virus encoding thyroidal sodium iodide symporter | Biological | Experimental Arm |
| reverse transcriptase-polymerase chain reaction | Genetic | Experimental Arm |
| laboratory biomarker analysis | Other | Experimental Arm |
Primary outcome
Dose Limiting Toxicity
Time frame: up to 12 months after last treatment
If one patient experiences a Dose limiting Toxicity(DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose
3 secondary outcomes
Number of Responses (Complete and Partial, Stable and Progressive Disease)
Time frame: up to 12 months after last treatment
Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months)
Time frame: baseline and up to 18 months
Time to Progression
Time frame: up to 12 months after last treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Evanthia Galanis, MD study chair
Mayo Clinic
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 carcinoembryonic antigen-expressing measles virus, oncolytic measles virus encoding thyroidal sodium iodide symporter and reverse transcriptase-polymerase chain reaction in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Mayo Clinic 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 18 inclusion and 26 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 16 Jan 2024. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose Limiting Toxicity (time frame: up to 12 months after last treatment). 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 16 Jan 2024.