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A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, and Determination of Radiation Dosimetry for 131-I-MIP-1145

Phase 1
18 Years
Not Enrolling
Metastatic Melanoma

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Trial Information

A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, and Determination of Radiation Dosimetry for 131-I-MIP-1145

Inclusion Criteria:

1. Provide written informed consent and be willing to comply with all protocol

2. Men and women 18 years of age or older

3. 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

- 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.

4. 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.

5. Historical diagnosis (surgical or histological) of primary melanoma with metastatic
melanoma confirmed by histology and/or radiologically via MRI/CT.

6. CT/MRI representing current measurable metastatic lesion (within 6 to 12 weeks of
entry; at least one lesion > 2cm in the longest dimension)

Exclusion Criteria:

1. Less than 18 years of age

2. Pregnant or breastfeeding

3. Inadequate venous access (defined as contralateral antecubital or equivalent venous
access sites which are required for study drug injection and PK blood sampling,

4. Uncontrolled glaucoma or retinopathy (e.g. macular degeneration) treated in the past

5. Cataracts or other lens opacities

6. 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.)

7. Patient received external beam therapy or chemotherapy within the last 30 days

8. Any history of head and neck radiotherapy

9. Karnofsky performance status is less than 60 (ECOG status > 2)

10. Serum creatinine is greater or equal to 2.0 mg/dL

11. Total bilirubin greater or equal to 1.5 times upper limit of normal

12. 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)

13. Received an investigational compound and/or medical device within 30 days before
admission into this study

14. 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

15. Any known allergy or sensitivity to iodine. Iodinated X-ray contrast hypersensitivity
is not an exclusion.

16. 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

17. Determined by the Investigator to be clinically unsuitable for the study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

September 2011

Related Keywords:

  • Metastatic Melanoma
  • cancer
  • oncology
  • melanoma
  • tumor
  • Melanoma



Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104