JPRN-UMIN000029922Not yet recruitingPhase 1
Phase 1/2 Study of Hyperthermic Isolated Limb Perfusion with Melphalan for Patients with In-Transit Malignant Melanoma of the Extremity - MM_ILI
Keio Univesity Hospital0 sites14 target enrollmentStarted: November 10, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 14
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 80years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1) Have allergic histories of Melphalan or iodine contrast agent. 2) Have a possibility of pregnancy or cannot agree with contraception between the date of informed consent and 3 months after treatment. 3) Have poorly controlled diseases such as heart diseases and pulmonary diseases that can be at risk of general anesthesia and avascularization of limbs. 4) Have in-transit metastases tend to be relieved by pretreatment (if invariant, can be registered even if it is not in exacerbation trend). 5) Be unlikely to survive for 3 months from the original registration due to progress of other organ metastasis. 6) Have a pretreatment history of chemotherapy, immunity checkpoint inhibitor (anti-CTLA-4 antibody) except for anti-PD-1 antibody, interferon alpha-2b, interferon beta, other immunotherapy, and molecular targeted therapeutic agents within 4 weeks from the date of registration. 7) Within 8 weeks after initiation of anti-PD-1 antibody, or after 8 weeks and effective for treatment. 8) Have a limb ischemic disease (such as obstructive arteriosclerosis and Buerger's disease), severe vasculitis. Doctors judge (In principle ABI 0.9 or above is the qualification criteria, and if less than 0.9, assess the suitability by MR angiography/ CT angiography.) 9) Have a symptomatic brain metastasis. 10) Be determined to be ineligible by doctors.
Investigators
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