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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    30
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 16 September 2021
platelet count
systemic therapy
measurable disease
metastasis
neutrophil count
cancer chemotherapy
dactinomycin
undifferentiated pleomorphic sarcoma
alveolar soft part sarcoma
advanced sarcoma

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).

Details
Condition Alveolar Soft Part Sarcoma, Connective and Soft Tissue Neoplasm, Malignant Fibrous Histiocytoma, Sarcoma, All Solid Tumors, Solid Tumors, Myxofibrosarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma, sarcomas, soft tissue sarcomas
Treatment Pembrolizumab, Isolated Limb Infusion, infusion of melphalan and dactinomycin
Clinical Study IdentifierNCT04332874
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patients who fulfil any of the following criteria are not eligible for
admission to the
study
Have any other malignancy that requires active treatment
Ineligible for ILI because of underlying physical conditions (e.g. coronary artery disease with inability to tolerate anesthesia) as determined by treating physician
Has previously experienced hypersensitivity to pembrolizumab or any of its excipients
Has uncontrolled intercurrent illness including active infection requiring systemic therapy or symptomatic congestive heart failure within the past 6 months
Has known active central nervous system (CNS) metastases. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to study Day 1 and return to baseline of neurologic symptoms), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include sarcomatous meningitis, which is excluded regardless of clinical stability
Shows evidence of clinically significant immunosuppression such as the following
Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
Concurrent opportunistic infection
Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 7 days prior to enrollment. However, in the setting of non-immune mediated indications for use, chronic/active low dose steroid use may be permitted at the discretion of the principal investigator
Has a known active or chronic infection with HIV if CD4 count is less than 500
Has a known active infection with hepatitis B or hepatitis C
Has a known history of active tuberculosis infection
Has history or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in the past 2 years. Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease
For female subjects, is pregnant or breast-feeding, or planning to become pregnant
For male subjects, is planning to father a child within the projected duration of the trial, starting with the pre-screening or screening visit, during study treatment and through 4 months after the last dose of pembrolizumab
For patients of childbearing potential, is unwilling to use acceptable method(s) of effective contraception during study treatment and through 4 months after the last dose of pembrolizumab
(Women not of childbearing potential are defined as: post-menopausal [age > 55
years with cessation of menses for 12 or more months or less than 55 years but
not spontaneous menses for at least 2 years or less than 55 years and
spontaneous menses within the past 1 year, but currently amenorrhoeic (e.g
spontaneous or secondary to hysterectomy), and with postmenopausal
gonadotropin levels (luteinizing hormone and follicle-stimulating hormone
levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according
to the definition of "postmenopausal range" for the laboratory involved] or
who have had a hysterectomy, bilateral salpingectomy, or bilateral
oophorectomy.)
Underwent prior chemotherapy, radiotherapy, biological cancer therapy, targeted small molecule therapy, or major surgery within 14 days prior to study Day 1 or has not recovered (i.e., to CTCAE </= grade 1 or at baseline) from adverse events due to previously administered therapy. Patients with </= grade 2 neuropathy and alopecia are an exception and may qualify for the study. If patients received major surgery, they must have recovered adequately prior to starting therapy
Is currently participating and receiving study therapy with another investigational device or study drug or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
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