Ovarian CancerPhase 1NCT03286062
VM110 in Detection of Microscopic Tumors: A Phase I Study
A Phase 1 study testing Agent VM110 and laproscopic infra-red probe in people with Ovarian Cancer and Pancreatic Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
A laproscopic imaging tecgnology that uses a synthetic agent to detect ovarian and pancreatic cancers at an early stage so that patients can get treatment early and prevent the disease from advancing to late stage leading to fatality or recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ovarian Cancer, Pancreatic Cancer
- What is being tested?
- Agent VM110 and laproscopic infra-red probe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2017to 3 Apr 2020
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known or suspected pancreatic or ovarian carcinoma who will be undergoing clinically appropriate laparoscopic evaluation or treatment. Patients will not undergo laparoscopy solely for the purpose of participation in this trial.
- Patients must have evidence of disease either through elevation of tumor markers or radiologic evidence of disease
- Patient may be male or female and of any race / ethnicity.
- Participation in this trial will not significantly alter pre-surgical, surgical or post-surgical care
- ECOG PS of 0-1
- Patients should be free of active infection requiring antibiotics
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- Any therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration
- Patients must have adequate:
- Renal function: serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
- Hepatic function: Total bilirubin less than or equal to 1.5 x ULN , SGOT and alkaline phosphatase less than or equal to 2.5 x ULN
- PTT (partial thromboplastin time) ≤ 1x ULN and INR ≤ 1.5 x ULN.
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after. Highly effective contraception methods include combination of any two of the following:
- Use of oral, injected or implanted hormonal methods of contraception, or;
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;
- Total abstinence or;
- Male/female sterilization
- Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.
- Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
- Age ≥ 18
- Capable of complying with study procedures and communicating with study personnel.
- Patients must have signed an approved informed consent and authorization permitting release of personal health information. Ability to understand and willingness to sign a written informed consent and HIPAA consent document
Who cannot join
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
- Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin used for catheter-related thrombosis prophylaxis).
- Prior history of hypersensitivity to Pegylated liposomal doxorubicin or ICG allergy. Caution should be taken if prior ICG allergy is noted.
- Pregnant or nursing (lactating) women
- History of congestive cardiac failure or an EKG suggesting significant conduction defect, or myocardial ischemia, or active psychiatric disease requiring treatment that would interfere with the understanding or conduct of the study.
- Subject has previously received VM110, or any other investigational product in the past thirty days.
- Inadequate tumor sites or volume to allow for biopsy per standard of care.
- Patients with psychiatric or other conditions rendering them incapable of participating in informed consent or the requirements of this protocol or other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
About this study
A laproscopic imaging tecgnology that uses a synthetic agent to detect ovarian and pancreatic cancers at an early stage so that patients can get treatment early and prevent the disease from advancing to late stage leading to fatality or recurrence.
Read the detailed description
Current methods of imaging techniques, CT, MRI and PET, fail to detect moderate volume of diffuse intraperitoneal tumor and provide limited functional information. White light laproscopy is capable of detecting small volume disease in only half of patients in clinical remission, missing occult disease in 30% of this patient population. In this study, a synthetic agent VM110 is to be tested for its ability to detect occult ovarian and pancreatic cancers. The agent is cleaved by proteases, cathepsin B, L, and S and plasmin in cancer cells and the fluorescent cleavage product is detected by near infra red imaging probe. High sensitivity of visualizaion of cancer cells can help detect sub-clinical disease otherwise unidentifiable by usual methods.
Primary Objectives
- To investigate the safety and toxicity of escalating doses of VM110 administered IV prior to laparoscopic surgery.
- To define the appropriate dose of VM110 for use in future trials.
- To define the preliminary efficacy: the optimal dose of VM110 in detection of microscopic peritoneal tumor at laparoscopy not visible with standard white light laparoscopy. Areas visible with both standard white light and NIRF light, and areas visible only with NIRF light will be biopsied. Data from pathologic evaluation of these specimens will be used to determine the efficacy of VM110 with respect to its ability to detect occult disease not visible with standard white light
Secondary Objectives
- Estimate sensitivity and specificity of VM110 detection
- Perform correlative pharmacologic and histopathological analyses
- Conditions
- Ovarian Cancer, Pancreatic Cancer
- Being tested
- Agent VM110 and laproscopic infra-red probe
- Medical subject headings
- Ovarian Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agent VM110 and laproscopic infra-red probeCombination product
Patients with evidence of persistent or recurrent ovarian/ pancreatic cancer would be injected with escalating dose of VM110 24 hr prior to laproscopic surgery to collect biopsy sample in white light and by visualizing the cancerous mass using the laproscopic infra red probe
| Study group | Role | What they receive |
|---|---|---|
| VM110 | Experimental | Escalating dose of agent VM110 given to patients to visualize occult cancer with laproscopic infra red detect Receives: Combination Product: Agent VM110 and laproscopic infra-red probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of VM110 related toxicity assessed by NCI CTCAE criteria 4.03
Patients would be monitored for severity of adverse events due to VM110 based on NCI CTCAE criteria 4.03
Measured: 3-62 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start12 Oct 2017
- Primary completion10 Jul 2019
- Study completion3 Apr 2020
Why it stopped: Slow accrual
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 Fox Chase Cancer CenterThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi dose Phase I study with injection of VM110 at 5 dose levels
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gina Martina-Smaldone, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286062
- Sponsor's protocol ID
- GYN-105
- Status last verified
- Apr 2020
- First submitted
- 13 Sep 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VM110 in Detection of Microscopic Tumors: A Phase I Study
- ClinicalTrials.gov ID
- NCT03286062
- Acronym / sponsor ID
- GYN-105
- Conditions
- Ovarian Cancer, Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 18 Sep 2017 (actual)
- 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.
A laproscopic imaging tecgnology that uses a synthetic agent to detect ovarian and pancreatic cancers at an early stage so that patients can get treatment early and prevent the disease from advancing to late stage leading to fatality or recurrence.
Detailed description
Current methods of imaging techniques, CT, MRI and PET, fail to detect moderate volume of diffuse intraperitoneal tumor and provide limited functional information. White light laproscopy is capable of detecting small volume disease in only half of patients in clinical remission, missing occult disease in 30% of this patient population. In this study, a synthetic agent VM110 is to be tested for its ability to detect occult ovarian and pancreatic cancers. The agent is cleaved by proteases, cathepsin B, L, and S and plasmin in cancer cells and the fluorescent cleavage product is detected by near infra red imaging probe. High sensitivity of visualizaion of cancer cells can help detect sub-clinical disease otherwise unidentifiable by usual methods.
Primary Objectives
- To investigate the safety and toxicity of escalating doses of VM110 administered IV prior to laparoscopic surgery.
- To define the appropriate dose of VM110 for use in future trials.
- To define the preliminary efficacy: the optimal dose of VM110 in detection of microscopic peritoneal tumor at laparoscopy not visible with standard white light laparoscopy. Areas visible with both standard white light and NIRF light, and areas visible only with NIRF light will be biopsied. Data from pathologic evaluation of these specimens will be used to determine the efficacy of VM110 with respect to its ability to detect occult disease not visible with standard white light
Secondary Objectives
- Estimate sensitivity and specificity of VM110 detection
- Perform correlative pharmacologic and histopathological analyses
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi dose Phase I study with injection of VM110 at 5 dose levels
| Arm | Type | Receives |
|---|---|---|
| VM110 | Experimental | Combination Product: Agent VM110 and laproscopic infra-red probeEscalating dose of agent VM110 given to patients to visualize occult cancer with laproscopic infra red detect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patients with known or suspected pancreatic or ovarian carcinoma who will be undergoing clinically appropriate laparoscopic evaluation or treatment. Patients will not undergo laparoscopy solely for the purpose of participation in this trial.
- Patients must have evidence of disease either through elevation of tumor markers or radiologic evidence of disease
- Patient may be male or female and of any race / ethnicity.
- Participation in this trial will not significantly alter pre-surgical, surgical or post-surgical care
- ECOG PS of 0-1
Key exclusion criteria (8 listed)
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
- Patients with an active bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin used for catheter-related thrombosis prophylaxis).
- Prior history of hypersensitivity to Pegylated liposomal doxorubicin or ICG allergy. Caution should be taken if prior ICG allergy is noted.
- Pregnant or nursing (lactating) women
- History of congestive cardiac failure or an EKG suggesting significant conduction defect, or myocardial ischemia, or active psychiatric disease requiring treatment that would interfere with the understanding or conduct of the study.
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 |
|---|---|---|
| Agent VM110 and laproscopic infra-red probePatients with evidence of persistent or recurrent ovarian/ pancreatic cancer would be injected with escalating dose of VM110 24 hr prior to laproscopic surgery to collect biopsy sample in white light and by visualizing the cancerous mass using the laproscopic infra red probe | Combination product | VM110 |
Primary outcome
Frequency and severity of VM110 related toxicity assessed by NCI CTCAE criteria 4.03
Time frame: 3-62 weeks
Patients would be monitored for severity of adverse events due to VM110 based on NCI CTCAE criteria 4.03
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Gina Martina-Smaldone, MD principal investigator
Fox Chase 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 Agent VM110 and laproscopic infra-red probe in people with Ovarian Cancer and Pancreatic Cancer, run by Fox Chase Cancer 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?
The sponsor lists 22 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Apr 2020. 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 was stopped early (reason given: Slow accrual). 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.
What does the primary outcome measure?
Frequency and severity of VM110 related toxicity assessed by NCI CTCAE criteria 4.03 (time frame: 3-62 weeks). 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 7 Apr 2020.