A Phase II Study of Concurrent Systemic Pembrolizumab and Isolated Limb Infusion (ILI) With Melphalan and Dactinomycin for Patients With Locally Advanced or Metastatic Extremity Sarcoma

Who is this study for? Adult patients with Alveolar Soft Part Sarcoma
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

∙ Patients must fulfill all of the following criteria to be eligible for admission to the study. Any exceptions from the protocol-specific selection criteria must be approved by the Principal Investigator and/or the Institutional Review Board (IRB) before enrollment.

• Age \>/= 12 years at the time of informed consent

• Willing and able to provide written informed consent/assent for the trial

• Willing to comply with treatment protocol

• Have a histologically confirmed metastatic and/or locally advanced sarcoma

• Eligible for standard treatment with pembrolizumab

• Eligible for an isolated limb infusion (ILI) as determined by the treating physician

• Have undergone at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy) or have declined the standard of care systemic option.

• Have measurable disease (at least one index lesion) as defined by RECIST 1.1 or by clinical measurement for superficial lesions not amenable to radiographic surveillance. Index lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment.

• Adequate performance status: ECOG \</= 2 or KPS \>/= 60%

• Adequate organ function determined within 3 weeks of treatment initiation, defined as follows:

‣ Hemoglobin \>/= 8.0 g/dL

⁃ Absolute neutrophil count \>/= 1,000/mm\^3 (1.0 x 10\^9/L)

⁃ Platelet count \>/= 50,000/mm\^3 (50 x 10\^9/L)

⁃ Serum bilirubin \</= 1.5 x upper limit of normal (ULN) OR direct bilirubin \</= ° ° ULN for a patient with total bilirubin level \> 1.5 x ULN Aspartate aminotransferase (AST) \</= 2.5 x ULN OR \</= 5 x ULN for patients with liver metastases

⁃ Alanine aminotransferase (ALT) \</= 2.5 x ULN OR \</= 5 x ULN for patients with liver metastases

⁃ Alkaline phosphatase \< 5 x ULN

⁃ Serum creatinine \</= 1.5 x ULN or a measured or calculated creatinine clearance \>/= 60 mL/min for a patient with creatinine levels \> 1.5 x institutional ULN (Note: Creatinine clearance need not be determined if the baseline serum creatinine is within normal limits. GFR can also be used in place of creatinine or CrCl)

⁃ International normalized ratio (INR) or prothrombin time (PT) \</= 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

⁃ Activated partial thromboplastin time (aPTT) \</= 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants

∙ Creatinine clearance should be calculated per institutional standard.

∙ For female patients of childbearing potential, negative serum pregnancy test at screening visit and within 72 h prior to the first dose of study medication.

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited protocol activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Edmund Bartlett, MD
bartlete@mskcc.org
212-639-2448
Backup
Charlotte Ariyan, MD, PhD
ariyanc@mskcc.org
212-639-6280
Time Frame
Start Date: 2020-04-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 30
Treatments
Experimental: Participants with Sarcoma
Advanced/metastatic extremity sarcoma eligible for pembrolizumab and isolated limb infusion (ILI)
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov