Case Report: Response to Regional Melphalan via Limb Infusion and Systemic PD1 Blockade in Recurrent Myxofibrosarcoma: A Report of 2 Cases.
Edmund K Bartlett, Sandra P D'Angelo, Ciara M Kelly...
https://pubmed.ncbi.nlm.nih.gov/34722269Actively Recruiting
Phase 2
Age: 12Years +
All Genders
ID04332874
A Phase II Study of Pembrolizumab with Isolated Limb Infusion of Melphalan and Dactinomycin for Locally Advanced or Metastatic Extremity Sarcoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-23
30
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for patients with locally advanced or metastatic sarcoma in the arm or leg. The study aims to determine if giving pembrolizumab together with chemotherapy drugs melphalan and dactinomycin directly to the affected limb using isolated limb infusion (ILI) is a safe way to delay disease progression. This trial is a Phase II study conducted by Memorial Sloan Kettering Cancer Center focusing on advanced extremity sarcoma. Participants receive pembrolizumab intravenously at a dose of 200 mg on Day 1 and then every three weeks. Pediatric patients receive a weight-based dose up to 200 mg. The isolated limb infusion procedure delivers melphalan and dactinomycin directly into the affected arm or leg via an arterial catheter under anesthesia. The chemotherapy infusion occurs within 18 days after starting pembrolizumab. Pediatric patients receive tailored anti-nausea treatment before the procedure. During the study, participants will be monitored for progression-free survival over six months. Researchers will assess disease status using measurable lesions defined by RECIST 1.1 or clinical evaluation for superficial lesions. Safety and organ function will be regularly checked through blood tests and clinical assessments. The study requires participants to have undergone at least one prior systemic therapy or declined standard options and to have adequate performance status and organ function. The trial continues until disease progression or other endpoints are met, with close follow-up throughout.
CONDITIONS
Brief Title
A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg
Who Can Participate
Age: 12Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 12 years or older at time of consent
- Willing and able to provide written informed consent or assent
- Willing to follow the treatment plan
- Histologically confirmed metastatic and/or locally advanced sarcoma
- Eligible for pembrolizumab treatment
- Eligible for isolated limb infusion as determined by physician
- Have had at least one prior systemic therapy or declined standard systemic treatment
- Have measurable disease by RECIST 1.1 or clinical measurement for superficial lesions
- Adequate performance status (ECOG ≤ 2 or KPS ≥ 60%)
- Adequate organ function within 3 weeks prior to treatment
- Negative pregnancy test for females of childbearing potential
- Willing to use effective contraception during treatment and 4 months after last dose
You will not qualify if you...
- Have any other cancer requiring active treatment
- Not eligible for isolated limb infusion due to physical conditions
- Previous hypersensitivity to pembrolizumab or its components
- Uncontrolled illnesses including active infection or recent heart failure
- Active central nervous system metastases or sarcomatous meningitis
- Clinically significant immunosuppression or recent systemic immunosuppressive therapy
- Active or chronic HIV with low CD4 count
- Active hepatitis B or C infection
- Active tuberculosis infection
- History of symptomatic or active autoimmune disease requiring systemic treatment in past 2 years
- Pregnant or breastfeeding females, or planning pregnancy
- Males planning to father a child during and shortly after the trial
- Unwillingness to use contraception if of childbearing potential
- Recent chemotherapy, radiotherapy, biological therapy, or major surgery within 14 days
- Participation in another investigational study within 3 weeks
- Psychiatric or substance abuse disorders interfering with trial participation
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive pembrolizumab intravenously on Day 1 and every 3 weeks thereafter. Isolated limb infusion of melphalan and dactinomycin is performed within 18 days of starting pembrolizumab under anesthesia.
Infusion visits every 3 weeks and 1 procedure visit for isolated limb infusion
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
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Research Team
E
Edmund Bartlett, MD
C
Charlotte Ariyan, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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