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A Phase 1/2, Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Melanoma

Phase 1/Phase 2
18 Years
Not Enrolling
Melanoma, Malignant Melanoma, Metastatic Melanoma

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Trial Information

A Phase 1/2, Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Melanoma

This is a multi-center, Phase 1/2 study evaluating the use of multiple intravenous doses of
131I-TM601 in adults patients with progressive and/or recurrent malignant melanoma (Stage
IIIc or IV) with measurable disease who have failed first line/standard therapy.

The study will be conducted in 2 phases. During the first, Dose Escalation Phase, eligible
patients wil be assigned in groups of 3-6 (depending upon the treatment response seen at
each dose) to dose cohorts of between 2-5 weekly IV doses of 131I-TM601. Escalation to the
next highest dose during the Dose Escalation Phase will be dependent upon demonstrated
tolerance in the previous dosing group. In the second, Efficacy Phase, all patients will be
treated with the Maximum Tolerated Dose determined in the Dose Escalation Phase.

Prior to initiating treatment, all patients will be administered a single imaging dose of
131I-TM601, IV, as an Imaging Dose to evaluate tumor uptake. Only patients demonstrating
tumor uptake will remain on the study.

Patients in both study phases will have safety parameters evaluated continuously throughout
the study. Clinical response to 131I-TM601 will be assessed in each study patient at 28
days following the final study dose, and then at 2-month intervals, starting at 3 months
following the first study dose (during the first year of follow-up), and finally at 3-month
intervals thereafter until disease progression.

Inclusion Criteria:

Patient MUST:

1. Have signed and dated written informed consent.

2. Be aged ≥ 18 years old at time of informed consent.

3. Have histologically proven Stage IIIc or IV malignant melanoma with documented
progression during or following the most recent prior melanoma therapy.

4. Have measurable disease, defined as lesions that can be accurately measured in at
least one dimension as > 20 mm with conventional techniques (CT) or > 10 mm with
spiral CT scan or brain MRI.

5. Have failed at least 1 prior therapy for melanoma or refused first-line, standard

6. Have an ECOG performance status of 0 - 1.

7. Have a life expectancy, based on the Investigator's judgment, of > 3 months.

8. On screening ECG, have a QTc interval of < 450 ms.

9. If taking steroids, be on a dose that is stable for at least 5 days prior to the
Imaging Dose.

10. Have recovered from the toxicity of all previous therapy prior to enrollment. If the
patient has undergone recent major surgery, an interval of at least 3 weeks must have
elapsed between the surgery and the date of the Imaging Dose.

11. Have acceptable laboratory results as follows:

1. Hemoglobin ≥ 9g/dL

2. ANC ≥ 1,500 mm3

3. Platelet count ≥ 150,000 mm3

4. PT <1.5 ULN

5. PTT < 1.5 ULN

6. Total Bilirubin < 2.0 mg/dL

7. AST/ALT < or = 5 ULN

8. Serum Creatinine < or = 2 mg/dL

12. Have a negative serum pregnancy test within 14 days of study drug administration, if
female and of child bearing potential.

13. Agree to use an effective form of contraception to avoid pregnancy, if fertile
(applicable to both male and female patients).

14. Agree to refrain from nursing, if female.

15. Be able to comply with treatment plan, study procedures, and follow-up examinations.

If enrolled in the single site Sub-Study, patient MUST:

16. Have at least one accessible biopsy site and a second measurable target site per
RECIST criteria.

17. Agree to pre-infusion and post-infusion biopsies of tumor lesions.

Exclusion Criteria:

Patient May Not:

1. Have a serious concurrent infection or medical illness which would jeopardize the
ability of the patient to receive the treatment outlined in this protocol with
reasonable safety. Examples of medical illnesses include, but are not limited to,
the following: uncontrolled hypertension, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, known history of HIV, Hepatitis B or
Hepatitis C infection, or psychiatric illness/social situation which would limit
compliance with study requirements.

2. Have CNS metastases, unless, in the PI's judgment, the CNS involvement is stable and
not likely to require further palliative therapy to the CNS during the course of the
treatment protocol. If previous treatment has included radiotherapy, CNS disease
should be stable at least 6 weeks from receipt of previous radiotherapy.

3. Have a prior malignancy with less than 3-year disease-free interval, except for
adequately treated basal cell or squamous cell carcinoma of the skin, or in situ
cancer of the cervix.

4. Have received radiation treatments < 6 weeks prior to first study drug administration
(Imaging Dose).

5. Have previously received radiation to ≥ 25% red bone marrow.

6. Have received any cytotoxic chemotherapy, hormonal therapy, or immunotherapy, whether
conventional or investigational, < 4 weeks prior to receiving the first study drug
(Imaging Dose) administration in this study (6 weeks for mitomycin-C or

7. Have a history of pulmonary embolism within 1 year or deep venous thrombosis within
six months of study enrollment.

8. Current or recent history of high-dose aspirin, warfarin, or heparin use (Aspirin <
or = 81 mg/day, low-dose warfarin < 1 mg/day, or low-dose heparin for IV catheter
patency is allowed).

9. Received investigational agents within 4 weeks prior to receiving the first study
drug (Imaging Dose) administration in this study.

10. Have a history of allergic reactions attributed to compounds of similar chemical or
biological composition to 131I-TM601 e.g. iodine or iodine-containing drugs.

Type of Study:


Study Design:

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

Outcome Measure:

Safety profile, as evaluated by incidence, severity, duration, causality, and seriousness of adverse events as well as by changes in patient's physical examination, vital signs, and clinical laboratory assessments.

Outcome Time Frame:

duration of the study

Safety Issue:


Principal Investigator

Thomas Gribbin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lacks Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Melanoma
  • Malignant Melanoma
  • Metastatic Melanoma
  • Melanoma
  • Malignant melanoma
  • metastatic melanoma
  • Phase 1
  • Phase 2
  • Melanoma



New York University School of Medicine New York, New York  10016
Lacks Cancer Center Grand Rapids, Michigan  49503
Mary Crowley Cancer Center Dallas, Texas  75246