Metastatic MelanomaPhase 1NCT00747825
Phase I Safety and Dosimetry Study in Patients With Confirmed Metastatic Melanoma
A Phase 1 study testing 131-I-MIP-1145 in people with Metastatic Melanoma, run by Molecular Insight Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is an open-label, single dose study for patients 18 years of age or older with confirmed metastatic melanoma. Up to 12 patients will be enrolled and all will receive an injection of approximately 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145 administered via IV injection. 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?
- 131-I-MIP-1145
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent and be willing to comply with all protocol requirements
- Men and women 18 years of age or older
- Female patients must meet 1 of the following criteria:
- not be of childbearing potential as documented by medical history (e.g., tubal ligation or hysterectomy), or be post menopausal with a minimum 1 year without menses
- Have a negative serum beta human chorionic gonadotropin (BHCG) pregnancy test within 48 hours prior to receiving the test article and agree to use a medically acceptable form of birth control, defined as abstinence or use of an intrauterine device (IUD), oral contraceptive, barrier and spermicide, or hormonal implant throughout the 28 day study period.
- Male patients of childbearing potential must agree to use at least one of the following medically acceptable forms of birth control throughout the 28 day study period; abstinence, barrier or other acceptable, effective contraceptive method.
- Historical diagnosis (surgical or histological) of primary melanoma with metastatic melanoma confirmed by histology and/or radiologically via MRI/CT.
- CT/MRI representing current measurable metastatic lesion (within 6 to 12 weeks of entry; at least one lesion > 2cm in the longest dimension)
Who cannot join
- Less than 18 years of age
- Pregnant or breastfeeding
- Inadequate venous access (defined as contralateral antecubital or equivalent venous access sites which are required for study drug injection and PK blood sampling, respectively)
- Uncontrolled glaucoma or retinopathy (e.g. macular degeneration) treated in the past year
- Cataracts or other lens opacities
- Any ophthalmologic intervention within the last 30 days (e.g., cataract extraction, laser procedure or equivalent, anti-VEGF treatment for macular degeneration. Topical treatments including antibiotics for conjunctivitis are allowed.)
Show all 17Show fewer
- Patient received external beam therapy or chemotherapy within the last 30 days
- Any history of head and neck radiotherapy
- Karnofsky performance status is less than 60 (ECOG status > 2)
- Serum creatinine is greater or equal to 2.0 mg/dL
- Total bilirubin greater or equal to 1.5 times upper limit of normal
- SGOT/AST or SGPT/ALT greater or equal to 3 times upper limit of normal (patients with metastatic liver disease are eligible if transaminase elevation is > 5 times the upper limit of normal)
- Received an investigational compound and/or medical device within 30 days before admission into this study
- Administered a 99mTc-labeled radioisotope < 3 days prior to imaging or < 7days prior to imaging for other diagnostic radioisotopes with half lives greater than 24 hours
- Any known allergy or sensitivity to iodine. Iodinated X-ray contrast hypersensitivity is not an exclusion.
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-injection follow-up examinations
- Determined by the Investigator to be clinically unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, and Determination of Radiation Dosimetry for 131-I-MIP-1145
This is an open-label, single dose study for patients 18 years of age or older with confirmed metastatic melanoma. Up to 12 patients will be enrolled and all will receive an injection of approximately 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145 administered via IV injection. The study will consist of a single dosing day followed by a 7-day assessment period and 21-day follow-up period. The total duration of the study from screening to final follow-up visit is approximately 60 days.
- Conditions
- Metastatic Melanoma
- Being tested
- 131-I-MIP-1145
- Keywords
- cancer, oncology, melanoma, tumor
- Medical subject headings
- Melanoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131-I-MIP-1145Drug
IV injection between 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startDec 2009
- Primary completionSep 2011
- Study completionSep 2011
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747825
- Sponsor's protocol ID
- SZ-M101
- Status last verified
- Oct 2011
- First submitted
- 4 Sep 2008
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, and Determination of Radiation Dosimetry for 131-I-MIP-1145
- ClinicalTrials.gov ID
- NCT00747825
- Acronym / sponsor ID
- SZ-M101
- Conditions
- Metastatic Melanoma
- Keywords
- cancer, oncology, melanoma, tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Sep 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.
This is an open-label, single dose study for patients 18 years of age or older with confirmed metastatic melanoma. Up to 12 patients will be enrolled and all will receive an injection of approximately 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145 administered via IV injection. The study will consist of a single dosing day followed by a 7-day assessment period and 21-day follow-up period. The total duration of the study from screening to final follow-up visit is approximately 60 days.
Study design
- Primary purpose
- Diagnosis
- 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 (8 listed)
- Provide written informed consent and be willing to comply with all protocol requirements
- Men and women 18 years of age or older
- Female patients must meet 1 of the following criteria:
- Male patients of childbearing potential must agree to use at least one of the following medically acceptable forms of birth control throughout the 28 day study period; abstinence, barrier or other acceptable, effective contraceptive method.
- Historical diagnosis (surgical or histological) of primary melanoma with metastatic melanoma confirmed by histology and/or radiologically via MRI/CT.
Key exclusion criteria (17 listed)
- Less than 18 years of age
- Pregnant or breastfeeding
- Inadequate venous access (defined as contralateral antecubital or equivalent venous access sites which are required for study drug injection and PK blood sampling, respectively)
- Uncontrolled glaucoma or retinopathy (e.g. macular degeneration) treated in the past year
- Cataracts or other lens opacities
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 |
|---|---|---|
| 131-I-MIP-1145IV injection between 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145 | Drug | – |
Primary outcome
Not reported in the source record.
1 secondary outcome
To estimate radiation absorbed doses (dosimetry) to known 131-I-MIP-1145 avid lesions and to the whole body, following a single bolus (IV) injection of approximately 4.0 to 6.0 mCi (148-222 MBq) of 131-I-MIP-1145.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
Related trials for Metastatic 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
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic 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.
The record lists no contact. Use the official record to reach the sponsor.
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 131-I-MIP-1145 in people with Metastatic Melanoma, run by Molecular Insight Pharmaceuticals, 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 8 inclusion and 17 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 12 Oct 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 was stopped early. 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.
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 12 Oct 2011.