MelanomaPhase 1NCT00680589
Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response
A Phase 1 study testing injection of mouse TYRP2 DNA in people with Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to find out about the safety of injecting the gene (DNA) for mouse TYRP2 in patients with melanoma. DNA is a material that contains the information needed to produce many substances in the body. TYRP2 is a substance found in melanoma cells that helps to produce their black color. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- injection of mouse TYRP2 DNA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Mar 2011
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For all patients, pathology slides must be reviewed by the Memorial Hospital Department of Pathology for confirmation of melanoma diagnosis.
- Patients must be HLA-A*0201 positive.
- Patients must have a Karnofsky performance status of at least 80.
- Patients must be free of detectable brain metastases.
- Patients must have adequate organ and marrow function as defined below:
- WBC ≥ than or = to 3,000/μL
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- Absolute neutrophil count ≥ than or = to 1,500/μL
- Platelets ≥ than or = to 100,000/μL
- Total bilirubin ≤ than or = to 1.5X upper normal institutional limits
- LDH ≤ than or = to 2 X institutional upper limit of normal
- Albumin ≥ than or = to 3.5 mg/dl
- Creatinine ≤ than or = to 2.0 mg/dl
- Hemoglobin ≥ than or = to 10 Gm/dl
- Liver AST, ALT ≤ than or = to 2.5 x ULN
- Patients must have no known HIV positivity
- Pediatric patients are eligible if weight is > 25 kg and parent/guardian completes informed assent process.
- Patients must understand and sign an informed consent and have specifically declined all standard or approved therapies for which they would be considered eligible. Parent or legal guardians of patients who are minors will sign the informed consent form.
- As part of the consent process, patients must agree to use contraception while on study.
Who cannot join
- Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. For nitrosoureas, at last six weeks must have elapsed.
- Patients with Grade I fever, active infection, or antibiotics within 72 hours prior to study.
- Patients who have previously been immunized with any class of vaccine containing TYRP2, including whole cell, shed antigen or cell lysate vaccine.
- Patients with a history of collagen vascular, rheumatological, or other autoimmune disorders.
- Any medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
- Patients who have preexisting retinal or choroidal eye disease.
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- Patients with serious underlying medical conditions that could be exacerbated by participation, active infections requiring antimicrobial drugs or active bleeding.
- Pregnant women or women who are nursing are not eligible. Women of child-bearing potential and sexually active men must be using appropriate contraception during the course of this study. Women of child-bearing potential must not be pregnant (negative βHCG within 2 weeks of immunization) nor be nursing during treatment.
- Patients receiving other investigational agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response
The goal of this study is to find out about the safety of injecting the gene (DNA) for mouse TYRP2 in patients with melanoma. DNA is a material that contains the information needed to produce many substances in the body. TYRP2 is a substance found in melanoma cells that helps to produce their black color. The DNA used in this study is the gene for mouse TYRP2.
The gene is introduced into bacteria, which are grown in large quantities. The DNA vaccine is then made from bacteria that is inactive.
We would like to see if we can immunize patients against TYRP2 by injecting mouse TYRP2 DNA. We will also follow the patients closely to see if there are any side effects. Mouse TYRP2 DNA is very similar to human TYRP2 DNA. We believe, based on lab experiments, that injection of mouse TYRP2 DNA could result in the production of immune substances (antibodies and T cells) that recognize melanoma cells. Antibodies are substances produced by your immune system to defend your body against bacteria and viruses. T cells are a type of white blood cell that can also fight infections. The small differences between mouse and human TYRP2 may allow your immune system to make the antibodies and T cells against melanoma. There is no evidence yet that injection of TYRP2 DNA results in any clinical benefit in patients.
- Conditions
- Melanoma
- Being tested
- injection of mouse TYRP2 DNA
- Keywords
- TYRP2 DNA Vaccine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of mouse TYRP2 DNABiological
Cohorts of three patients will receive injections with mouse TYRP2 DNA delivered intramuscularly at four different dose levels (500, 2000, 4000 or 8000 μg) every three weeks for six injections.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Injection of mouse TYRP2 DNA in patients with highrisk melanoma. Receives: Biological: injection of mouse TYRP2 DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and feasibility of intra-muscular DNA injection with mouse TYRP2 DNA. Doses will be escalated by groups to determine the maximal tolerated dose.
Measured: conclusion of study
Secondary outcomes (1)
A secondary endpoint is to observe the patients for evidence of any antitumor response generated after immunizations.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJul 2006
- Primary completionMar 2011
- Study completionMar 2011
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.
- More trials run by Memorial Sloan Kettering 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Jedd Wolchok, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680589
- Sponsor's protocol ID
- 06-052
- Status last verified
- Mar 2011
- First submitted
- 15 May 2008
- Last updated
- 28 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response
- ClinicalTrials.gov ID
- NCT00680589
- Acronym / sponsor ID
- 06-052
- Conditions
- Melanoma
- Keywords
- TYRP2 DNA Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 20 May 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.
The goal of this study is to find out about the safety of injecting the gene (DNA) for mouse TYRP2 in patients with melanoma. DNA is a material that contains the information needed to produce many substances in the body. TYRP2 is a substance found in melanoma cells that helps to produce their black color. The DNA used in this study is the gene for mouse TYRP2.
The gene is introduced into bacteria, which are grown in large quantities. The DNA vaccine is then made from bacteria that is inactive.
We would like to see if we can immunize patients against TYRP2 by injecting mouse TYRP2 DNA. We will also follow the patients closely to see if there are any side effects. Mouse TYRP2 DNA is very similar to human TYRP2 DNA. We believe, based on lab experiments, that injection of mouse TYRP2 DNA could result in the production of immune substances (antibodies and T cells) that recognize melanoma cells. Antibodies are substances produced by your immune system to defend your body against bacteria and viruses. T cells are a type of white blood cell that can also fight infections. The small differences between mouse and human TYRP2 may allow your immune system to make the antibodies and T cells against melanoma. There is no evidence yet that injection of TYRP2 DNA results in any clinical benefit in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: injection of mouse TYRP2 DNAInjection of mouse TYRP2 DNA in patients with highrisk melanoma. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- For all patients, pathology slides must be reviewed by the Memorial Hospital Department of Pathology for confirmation of melanoma diagnosis.
- Patients must be HLA-A*0201 positive.
- Patients must have a Karnofsky performance status of at least 80.
- Patients must be free of detectable brain metastases.
- Patients must have adequate organ and marrow function as defined below:
Key exclusion criteria (9 listed)
- Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. For nitrosoureas, at last six weeks must have elapsed.
- Patients with Grade I fever, active infection, or antibiotics within 72 hours prior to study.
- Patients who have previously been immunized with any class of vaccine containing TYRP2, including whole cell, shed antigen or cell lysate vaccine.
- Patients with a history of collagen vascular, rheumatological, or other autoimmune disorders.
- Any medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
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 |
|---|---|---|
| injection of mouse TYRP2 DNACohorts of three patients will receive injections with mouse TYRP2 DNA delivered intramuscularly at four different dose levels (500, 2000, 4000 or 8000 μg) every three weeks for six injections. | Biological | 1 |
Primary outcome
To evaluate the safety and feasibility of intra-muscular DNA injection with mouse TYRP2 DNA. Doses will be escalated by groups to determine the maximal tolerated dose.
Time frame: conclusion of study
1 secondary outcome
A secondary endpoint is to observe the patients for evidence of any antitumor response generated after immunizations.
Time frame: conclusion of study
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 28 Mar 2011.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Jedd Wolchok, MD principal investigator
Memorial Sloan Kettering 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 injection of mouse TYRP2 DNA in people with Melanoma, run by Memorial Sloan Kettering 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 18 inclusion and 9 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 28 Mar 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 evaluate the safety and feasibility of intra-muscular DNA injection with mouse TYRP2 DNA. Doses will be escalated by groups to determine the maximal tolerated dose. (time frame: conclusion of study). 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 28 Mar 2011.