Phase I Safety and Dosimetry Study in Patients With Confirmed Metastatic Melanoma
This study has been terminated.
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
First received: September 4, 2008
Last updated: October 7, 2011
Last verified: October 2011
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.
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, and Determination of Radiation Dosimetry for 131-I-MIP-1145
Secondary Outcome Measures:
- 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. [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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)
- 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.)
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747825
|Hospital of the University of Pennsylvania
|Philadelphia, Pennsylvania, United States, 19104-4283 |
Molecular Insight Pharmaceuticals, Inc.
No publications provided
||Molecular Insight Pharmaceuticals, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 4, 2008
||October 7, 2011
||United States: Food and Drug Administration
Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas