MelanomaPhase 1/2NCT01888081
A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation for Treatment of Stage IV Melanoma
A Phase 1/2 study testing A-dmDT390-bisFv(UCHT1) (Resimmune®) and Ionizing Radiation in people with Melanoma, run by Virogen Biotechnology Inc. at 1 site in United States.
Trial summary
The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable with median overall survival periods that range from 8-16 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Melanoma
- What is being tested?
- A-dmDT390-bisFv(UCHT1) (Resimmune®) and Ionizing Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2020
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have histologically proven stage IV metastatic melanoma consisting of at least two lesions
- Patients must have a performance status of < 2 on Eastern Cooperative Oncology Group scale (see Appendix).
- Patients must have bilirubin < 1.5 mg/dL, transaminases < 2.5 X ULN, albumin > 3 gm/dL, creatinine < 2.0 mg/dL, adequate pulmonary function by physical exam and pulse oximetry and adequate cardiac reserve (EF > 50% normal). Patients must have a normal echocardiogram without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis.
- Patients must give written informed consent prior to registration.
- Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.
- Patients of ages 18-80 are eligible provided they have stage IV melanoma and are negative for BRAF or have failed BRAF inhibitor treatment or if they have failed or are intolerant to other established therapy known to provide clinical benefit for their condition or if they have been adequately consented and agreed to forgo FDA approved clinically meaningful therapy
Who cannot join
- Inability to give informed consent because of psychiatric problems, or complicated medical problems.
- Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC).
- Preexisting cardiovascular disease, the only exception being well controlled essential hypertension with a sitting blood pressure of <155 systolic and <90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction > 8 months ago. A past history of the any of the following are exclusions: congestive heart failure, atrial fibrillation, pulmonary hypertension, anticoagulant drug therapy, thromboembolic events, cardiomyopathy or a myocardial infarction within the past 8 months.
- Pregnant or nursing women will be excluded from study.
- History of congestive heart failure.
- History of cirrhosis of the liver
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: Phase I/II Trial of A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation for the Treatment of Stage IV Melanoma
The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable with median overall survival periods that range from 8-16 months.
Read the detailed description
A-dmDT390-bisFv(UCHT1) (Resimmune™), an anti-T cell immunotoxin is currently being studied as a treatment for cutaneous T cell lymphoma and other CD3+ malignant diseases (FDA IND Number: 100712, Scott and White Protocol 071163). During the course of this study, data accumulated that Resimmune could be acting as an immunomodulator. This was based on the observation that four out of six partial responses converted to complete responses at times ranging between 6 and 24 months following the completion of the 4-day treatment protocol and no other treatment took place.
The purpose of this trial is to test the hypothesis that Resimmune can act as an immunomodulator of late stage metastatic melanoma when combined with palliative radiation to induce the priming of activated T cells with tumor antigens. The primary objective of this study is to determine the safety of combining Resimmune with palliative radiation therapy in patients with stage IV melanoma. A secondary objective is to document the tumor response and duration of response at irradiated and unirradiated sites (the abscopal effect). An additional secondary objective is to determine if T cell activation occurs following administration of A-dmDT390-bisFv(UCHT1) and local radiation to a metastatic lesion of melanoma.
- Conditions
- Melanoma
- Being tested
- A-dmDT390-bisFv(UCHT1) (Resimmune®), Ionizing Radiation
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-dmDT390-bisFv(UCHT1) (Resimmune®)Drug
Ionizing RadiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| A-dmDT390-bisFv(UCHT1) with Ionizing Radiation | Experimental | A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation Receives: Drug: A-dmDT390-bisFv(UCHT1) (Resimmune®); Radiation: Ionizing Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune-related overall response rate (irORR)
Response will be assessed at 2 months, and at least every 3 months (±7 days) thereafter using for up to 1 year after the last treatment administration or until evidence of disease progression. Tumor measurements and therapeutic response will be determined using irRC (Immune Related Response Criteria). At a minimum, CT scans of the chest, abdomen, and pelvis will be performed at study entry, at 2 months, and, if a response or stable disease, at least every 3 months (±7 days) for up to 1 year after the last dose of study drug, and/or at any time there is clinical evidence of disease progression, to evaluate disease status.
Measured: For up to 1 year post treatment or until disease progression
Secondary outcomes (1)
Overall survival
Survival should be assessed and a physical exam should be completed every three months as per standard of care
Measured: every 3 months for up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2020 (estimated)
Why it stopped: Protocol replaced with combination therapy adding KEYTRUDA (pembrolizumab)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virogen Biotechnology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Louisville
- Responsible party
- Sponsor
- Investigators
- Jason Chesney, MD, PhD, Principal investigator, James Graham Brown Cancer Center, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888081
- Sponsor's protocol ID
- BCC-MEL-13
- Status last verified
- Nov 2016
- First submitted
- 21 Jun 2013
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation for the Treatment of Stage IV Melanoma
- ClinicalTrials.gov ID
- NCT01888081
- Acronym / sponsor ID
- BCC-MEL-13
- Conditions
- Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol replaced with combination therapy adding KEYTRUDA (pembrolizumab)
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Virogen Biotechnology Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Louisville
- Study start
- Feb 2014
- Primary completion
- Dec 2020 (estimated)
- First posted
- 27 Jun 2013 (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 purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable with median overall survival periods that range from 8-16 months.
Detailed description
A-dmDT390-bisFv(UCHT1) (Resimmune™), an anti-T cell immunotoxin is currently being studied as a treatment for cutaneous T cell lymphoma and other CD3+ malignant diseases (FDA IND Number: 100712, Scott and White Protocol 071163). During the course of this study, data accumulated that Resimmune could be acting as an immunomodulator. This was based on the observation that four out of six partial responses converted to complete responses at times ranging between 6 and 24 months following the completion of the 4-day treatment protocol and no other treatment took place.
The purpose of this trial is to test the hypothesis that Resimmune can act as an immunomodulator of late stage metastatic melanoma when combined with palliative radiation to induce the priming of activated T cells with tumor antigens. The primary objective of this study is to determine the safety of combining Resimmune with palliative radiation therapy in patients with stage IV melanoma. A secondary objective is to document the tumor response and duration of response at irradiated and unirradiated sites (the abscopal effect). An additional secondary objective is to determine if T cell activation occurs following administration of A-dmDT390-bisFv(UCHT1) and local radiation to a metastatic lesion of melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A-dmDT390-bisFv(UCHT1) with Ionizing Radiation | Experimental | Drug: A-dmDT390-bisFv(UCHT1) (Resimmune®), Radiation: Ionizing RadiationA-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients must have histologically proven stage IV metastatic melanoma consisting of at least two lesions
- Patients must have a performance status of < 2 on Eastern Cooperative Oncology Group scale (see Appendix).
- Patients must have bilirubin < 1.5 mg/dL, transaminases < 2.5 X ULN, albumin > 3 gm/dL, creatinine < 2.0 mg/dL, adequate pulmonary function by physical exam and pulse oximetry and adequate cardiac reserve (EF > 50% normal). Patients must have a normal echocardiogram without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis.
- Patients must give written informed consent prior to registration.
- Females and males must be willing to use an approved form of birth control while on this study and for 2 weeks after completion.
Key exclusion criteria (6 listed)
- Inability to give informed consent because of psychiatric problems, or complicated medical problems.
- Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC).
- Preexisting cardiovascular disease, the only exception being well controlled essential hypertension with a sitting blood pressure of <155 systolic and <90 diastolic without any evidence of structural heart disease or one episode of myocardial infarction > 8 months ago. A past history of the any of the following are exclusions: congestive heart failure, atrial fibrillation, pulmonary hypertension, anticoagulant drug therapy, thromboembolic events, cardiomyopathy or a myocardial infarction within the past 8 months.
- Pregnant or nursing women will be excluded from study.
- History of congestive heart failure.
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 |
|---|---|---|
| A-dmDT390-bisFv(UCHT1) (Resimmune®) | Drug | A-dmDT390-bisFv(UCHT1) with Ionizing Radiation |
| Ionizing Radiation | Radiation | A-dmDT390-bisFv(UCHT1) with Ionizing Radiation |
Primary outcome
Immune-related overall response rate (irORR)
Time frame: For up to 1 year post treatment or until disease progression
Response will be assessed at 2 months, and at least every 3 months (±7 days) thereafter using for up to 1 year after the last treatment administration or until evidence of disease progression. Tumor measurements and therapeutic response will be determined using irRC (Immune Related Response Criteria). At a minimum, CT scans of the chest, abdomen, and pelvis will be performed at study entry, at 2 months, and, if a response or stable disease, at least every 3 months (±7 days) for up to 1 year after the last dose of study drug, and/or at any time there is clinical evidence of disease progression, to evaluate disease status.
1 secondary outcome
Overall survival
Time frame: every 3 months for up to 3 years
Results and safety
The study was stopped early (reason given: Protocol replaced with combination therapy adding KEYTRUDA (pembrolizumab)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Jason Chesney, MD, PhD principal investigator
James Graham Brown Cancer Center, University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A-dmDT390-bisFv(UCHT1) (Resimmune®) and Ionizing Radiation in people with Melanoma, run by Virogen Biotechnology Inc. 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 6 inclusion and 6 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 23 Nov 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 combined 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.
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?
The study was stopped early (reason given: Protocol replaced with combination therapy adding KEYTRUDA (pembrolizumab)). 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?
Immune-related overall response rate (irORR) (time frame: For up to 1 year post treatment or until disease progression). 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 23 Nov 2016.