Metastatic MelanomaPhase 1NCT00399113
Safety Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
A Phase 1 study testing 188Re-PTI-6D2 in people with Metastatic Melanoma, run by Pain Therapeutics at 2 sites in Israel.
Trial summary
The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order to provide information on how the monoclonal antibody is distributed throughout the body and to assess tumor targeting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- 188Re-PTI-6D2
- How many people
- 12 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2007to Jun 2008
- 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
- Histologically confirmed Stage IIIc (unresectable) or Stage IV metastatic melanoma;
- measurable disease;
- at least 18 years of age;
- Karnofsky status at least 50%;
- life expectancy > 3 months;
- at least 4 weeks since prior therapy;
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- adequate organ and marrow function defined by screening laboratory tests;
- negative screening human anti-murine antibodies;
- females of child-bearing potential must be practicing an acceptable method of birth control and have a negative urine pregnancy test;
- written informed consent obtained
Who cannot join
- Chemotherapy or radiation therapy within 4 weeks or poor recovery from therapy > 4 weeks ago;
- investigational drug within 30 days;
- brain metastasis (all patients must have contrast-enhanced MRI within 2 weeks of treatment to rule out);
- ocular inflammatory disease or ocular neoplasm (all patients must have fundoscopic and slit lamp examination within 2 weeks of treatment to rule out exclusionary ocular pathology);
- prior parenteral exposure to murine proteins;
- positive hep B surface Ag, hep C antibody, or HIV test at screening;
- uncontrolled intercurrent illness;
- pregnant/breast-feeding.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Hebrew University Hospital
Jerusalem, 91120
Chaim Sheba Medical Center
Tel HaShomer, 52621
About this study
Official title: An Open-Label Phase I Safety, Pharmacokinetic & Dosimetry Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
The purpose of this first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order to provide information on how the monoclonal antibody is distributed throughout the body and to assess tumor targeting. No therapeutic dose of radiation will be given in the first study.
Read the detailed description
This study will evaluate the safety and feasibility of the administration of 188Re-PTI-6D2 in patients with metastatic melanoma. Patients with confirmed Stage IIIc (unresectable) or Stage IV melanoma who meet all eligibility criteria will undergo a thorough physical examination and baseline tumor imaging (whole body 18FDG PET/CT and MRI brain) to document all sites of tumor.
Treatment will be administered on an inpatient basis. An initial cohort of 3 patients will receive a tracer dose of 188Re-PTI-6D2 without any preceding unlabeled antibody. The tracer dose will consist of 10 mCi of rhenium-labeled antibody; the amount of antibody (in mg) will depend on specific activity and is estimated to range from 2 to 10 mg. Additional cohorts of three patients each will receive 10 mg, 20 mg, and 50 mg of unlabeled PTI-6D2 immediately preceding administration of the tracer dose. Patients will undergo serial gamma scans and SPECT/CT imaging at specified time points. Blood samples will be obtained prior to dosing and at specified intervals for PK measurements of the mAb as well as for measurement of serum radioactivity. Urine will also be collected for all patients to measure excreted radioactivity. Patients will be closely monitored for safety throughout the duration of the study.
Patients will remain at the study center for 48 hours after infusion to allow adequate time for post-treatment safety observation, monoclonal antibody clearance and rhenium decay. Prior to the escalation of the dose of unlabeled PTI-6D2, safety data from the inpatient period and 2-week follow-up visit for the three patients at the current dose level will be reviewed. If there is no evidence of a safety risk, the dose of unlabeled PTI-6D2 will be escalated for the next cohort of patients. Dose escalation of unlabeled antibody will occur according to a specific scheme.
- Conditions
- Metastatic Melanoma
- Being tested
- 188Re-PTI-6D2
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
188Re-PTI-6D2Drug
monoclonal antibody
What is being measured
The primary outcome is the main question the study is designed to answer.
To select the amount of unlabeled PTI-6D2 to administer immediately prior to a tracer dose of 188Re-PTI-6D2 in order to achieve preferred tumor targeting
To generate pharmacokinetic (PK) and biodistribution data of 188Re-PTI-6D2 in patients with metastatic melanoma in order to estimate radiation doses absorbed to tumor and critical organs
To determine the frequency of HAMA response associated with 188Re-PTI-6D2 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startMay 2007
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eithan Galun, M.D., Principal investigator, Hadassah Hebrew University HospitalJacob Schachter, M.D., Principal investigator, Chaim Sheba Medical CenterTzila Zwas, M.D., Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399113
- Sponsor's protocol ID
- PTI-6D2-A
- Status last verified
- Jul 2011
- First submitted
- 13 Nov 2006
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase I Safety, Pharmacokinetic & Dosimetry Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00399113
- Acronym / sponsor ID
- PTI-6D2-A
- Conditions
- Metastatic Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pain TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jun 2008 (actual)
- First posted
- 14 Nov 2006 (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 first-in-man study is to evaluate the safety of 188Re-PTI-6D2 in patients with metastatic melanoma. All patients will receive a tracer dose of 188Re-PTI-6D2 in order to provide information on how the monoclonal antibody is distributed throughout the body and to assess tumor targeting. No therapeutic dose of radiation will be given in the first study.
Detailed description
This study will evaluate the safety and feasibility of the administration of 188Re-PTI-6D2 in patients with metastatic melanoma. Patients with confirmed Stage IIIc (unresectable) or Stage IV melanoma who meet all eligibility criteria will undergo a thorough physical examination and baseline tumor imaging (whole body 18FDG PET/CT and MRI brain) to document all sites of tumor.
Treatment will be administered on an inpatient basis. An initial cohort of 3 patients will receive a tracer dose of 188Re-PTI-6D2 without any preceding unlabeled antibody. The tracer dose will consist of 10 mCi of rhenium-labeled antibody; the amount of antibody (in mg) will depend on specific activity and is estimated to range from 2 to 10 mg. Additional cohorts of three patients each will receive 10 mg, 20 mg, and 50 mg of unlabeled PTI-6D2 immediately preceding administration of the tracer dose. Patients will undergo serial gamma scans and SPECT/CT imaging at specified time points. Blood samples will be obtained prior to dosing and at specified intervals for PK measurements of the mAb as well as for measurement of serum radioactivity. Urine will also be collected for all patients to measure excreted radioactivity. Patients will be closely monitored for safety throughout the duration of the study.
Patients will remain at the study center for 48 hours after infusion to allow adequate time for post-treatment safety observation, monoclonal antibody clearance and rhenium decay. Prior to the escalation of the dose of unlabeled PTI-6D2, safety data from the inpatient period and 2-week follow-up visit for the three patients at the current dose level will be reviewed. If there is no evidence of a safety risk, the dose of unlabeled PTI-6D2 will be escalated for the next cohort of patients. Dose escalation of unlabeled antibody will occur according to a specific scheme.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed Stage IIIc (unresectable) or Stage IV metastatic melanoma;
- measurable disease;
- at least 18 years of age;
- Karnofsky status at least 50%;
- life expectancy > 3 months;
Key exclusion criteria (8 listed)
- Chemotherapy or radiation therapy within 4 weeks or poor recovery from therapy > 4 weeks ago;
- investigational drug within 30 days;
- brain metastasis (all patients must have contrast-enhanced MRI within 2 weeks of treatment to rule out);
- ocular inflammatory disease or ocular neoplasm (all patients must have fundoscopic and slit lamp examination within 2 weeks of treatment to rule out exclusionary ocular pathology);
- prior parenteral exposure to murine proteins;
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 |
|---|---|---|
| 188Re-PTI-6D2monoclonal antibody | Drug | – |
Primary outcome
To select the amount of unlabeled PTI-6D2 to administer immediately prior to a tracer dose of 188Re-PTI-6D2 in order to achieve preferred tumor targeting
To generate pharmacokinetic (PK) and biodistribution data of 188Re-PTI-6D2 in patients with metastatic melanoma in order to estimate radiation doses absorbed to tumor and critical organs
To determine the frequency of HAMA response associated with 188Re-PTI-6D2 administration
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 14 Jul 2011.
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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.
Eithan Galun, M.D. principal investigator
Hadassah Hebrew University Hospital
Jacob Schachter, M.D. principal investigator
Chaim Sheba Medical Center
Tzila Zwas, M.D. principal investigator
Chaim Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 188Re-PTI-6D2 in people with Metastatic Melanoma, run by Pain Therapeutics at 2 sites in Israel.
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 10 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: finished, as of the sponsor's last update on 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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 select the amount of unlabeled PTI-6D2 to administer immediately prior to a tracer dose of 188Re-PTI-6D2 in order to achieve preferred tumor targeting. The study lists 3 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 14 Jul 2011.