A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04332874
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alveolar Soft Part Sarcoma
  • Myxofibrosarcoma
  • Sarcoma
  • Undifferentiated Pleomorphic Sarcoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isolated Limb Infusion — PROCEDURE
    ILI will be performed within 18 days of initiation of pembrolizumab. ILI (infusion of melphalan and dactinomycin into the affected limb via arterial catheter) will be performed in the interventional radiology suite under anesthesia. In pediatric patients, the pediatric pharmacist w ill be consulted prior to the procedure, and an appropriate prophylactic anti-emetic therapy and dose will be selected for the individual patient.
  • Pembrolizumab — DRUG
    Pembrolizumab at a dose of 200 mg will be administered intravenously on Day 1 and every 3 weeks(+/= 3 days) thereafter. In adolescent patients, the dosing of pembrolizumab w ill be 2 mg/kg up to a maximum of 200 mg.
  • infusion of melphalan and dactinomycin — DRUG
    infusion of melphalan and dactinomycin

Study Details

The purpose of this study is to find out whether giving the study drug pembrolizumab in combination with the chemotherapy drugs melphalan and dactinomycin, delivered directly to the affected arm or leg using a technique called isolated limb infusion (ILI), is a safe treatment that can delay the time before your disease gets worse (progresses).

Key Dates

Start date
Apr 1, 2020
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with Sarcoma
    Advanced/metastatic extremity sarcoma eligible for pembrolizumab and isolated limb infusion (ILI)

Primary Outcome Measure

Progression free survival [ Time Frame: 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)Basking RidgeNew Jersey07920
Edmund Barlett, MD
212-639-2448
Memorial Sloan Kettering Monmouth (Limited protocol activities)MiddletownNew Jersey07748
Edmund Barlett, MD
212-639-2448
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Edmund Barlett, MD
212-639-2448
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Edmund Barlett, MD
212-639-2448
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Edmund Barlett, MD
212-639-2448
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Edmund Bartlett, MD
212-639-2448
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Edmund Barlett, MD
212-639-2448

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Memorial Sloan Kettering Basking Ridge (Limited protocol activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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