Status:
COMPLETED
A Study of LY2880070 and Gemcitabine in People With Ewing Sarcoma,Ewing-Like Sarcoma, and Desmoplastic Small Round Cell Tumor
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Ewing Sarcoma
Ewing-Like Sarcoma
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out whether LY2880070 combined with the chemotherapy drug gemcitabine is an effective treatment for Ewing sarcoma or Ewing-like sarcoma.
Eligibility Criteria
Inclusion
- Consent/Assent: all patients and/or their parents or legally authorized representatives must sign written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
- Weight/Age: patients must be ≥40 kg at the time of study enrollment, but may be of any age
- Diagnosis: Patients must have histologically documented locally advanced or metastatic disease confirmed at MSK as follows:
- Main cohort: Ewing sarcoma as molecularly defined by an EWSR1 fusion with an ETS-transcription factor family member including FLI1, ERG, ETV1, ETV4, and FEV
- Pilot cohort: Ewing-like sarcomas including CIC-rearranged sarcoma, BCOR-rearranged sarcoma, and sarcomas with a rearrangement between EWSR1 and a non-ETS family gene or desmoplastic small round cell tumor as molecularly defined by an EWSR1-WT1 fusion
- Note: Any patient being enrolled into the pilot cohort that does not have a CIC, BCOR- rearranged sarcoma, or desmoplastic small round cell tumor will be reviewed with study pathologist, Dr. Cristina Antonescu, to ensure the categorization as Ewing-like sarcoma is appropriate
- Patients must be able to swallow capsules
- Therapeutic options: patient's current disease state must be one which has failed standard cytotoxic chemotherapy including cyclophosphamide/doxorubicin/vincristine and ifosfamide/etoposide
- Disease Status: patients must have measurable disease based on RECIST 1.1
- Performance level: Karnofsky ≥70% for patients \>16 years of age and Lansky ≥70 for patients ≤16 years of age
- Prior Therapy: patients may have had any number of regimens and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
- Note: Patients who have previously received gemcitabine will be allowed unless they had hypersensitivity or unacceptable toxicity attributed to gemcitabine
- ≥ 21 days must have elapsed after the last dose of cytotoxic or myelosuppressive chemotherapy and patients must have recovered from the acute toxic effects of these agents (other than alopecia)
- ≥ 14 days must have elapsed after radiation therapy, and toxicity related to prior radiation therapy must be recovered to grade ≤ 1
- ≥ 21 days must have elapsed after the last dose of antibody therapy, and toxicity related to prior antibody therapy must be recovered to grade ≤ 1
- Organ Function Requirements:
- Adequate bone marrow function defined as:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 8 g/dl
- Adequate renal function defined as estimated glomerular filtration (eGFR) rate ≥ 60 mL/min/1.73m2:
- as estimated by CKD-EPI equation for patients ≥ 18 years of age OR
- As estimated by cystatin C for patients \< 18 years of age
- Adequate liver function defined as:
- Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal for age
- AST or ALT ≤ 2.5 x upper limit of normal for patients without liver metastases
- AST or ALT ≤ 5 x upper limit of normal for patients with liver metastases
- Serum albumin ≥ 2.5 g/dl
- Adequate cardiac function defined as:
- Left ventricular ejection fraction (LVEF) \>45% as measured on echocardiogram, cardiac MRI, or MUGA
- QTc \< 470 ms on screening 12 lead electrocardiogram
- Pregnancy/Contraception
- Post-menarchal females must have a negative urine or serum pregnancy test at screening and ≤ 24 hours prior to study treatment
- Males or females of reproductive potential must be willing to use a barrier method of contraception throughout the course of the study and for 6 months after completing study treatment
Exclusion
- Patients for whom the investigator deems that gemcitabine is not appropriate
- Patients who have an uncontrolled infection
- Central Nervous System (CNS) Metastases
- Patients who have symptomatic central nervous system (CNS) metastases. Note: patients with treated and asymptomatic CNS metastases are eligible.
- Patients with CNS metastases requiring corticosteroids for management
- If the treatment of CNS disease requires anticonvulsants, the dose must have been stable for ≥ 4 weeks.
- Patients who are pregnant or breast feeding
- Patients who have a history of Torsades de Pointes, carry a diagnosis of congestive heart failure, or have a family history of prolonged QT syndrome
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
- Patients with known hypersensitivity to gemcitabine
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05275426
Start Date
March 2 2022
End Date
August 11 2025
Last Update
August 15 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065