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Anti-metabolites
LY2880070 + Gemcitabine for Ewing Sarcoma
Phase 2
Recruiting
Led By Emily Slotkin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Therapeutic options: patient's current disease state must be one which has failed standard cytotoxic chemotherapy including cyclophosphamide/doxorubicin/vincristine and ifosfamide/etoposide
Must not have
Patients who have an uncontrolled infection
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a new drug, LY2880070, combined with the chemotherapy drug gemcitabine, can effectively treat Ewing sarcoma or Ewing-like sarcoma. These cancers are tough to treat, and the combination aims to stop cancer cells from growing and dividing more effectively than current treatments. Gemcitabine is an active drug in advanced breast cancer both as a single agent and in combination with other chemotherapeutic agents.
Who is the study for?
This trial is for individuals of any age who weigh at least 40 kg and can swallow capsules. They must have Ewing sarcoma or similar, with measurable disease confirmed by specific molecular features. Participants need to be relatively healthy (Karnofsky ≥70% or Lansky ≥70), have adequate organ function, and no more than four prior cancer treatments. Pregnant individuals, those with certain heart conditions, uncontrolled infections, or hypersensitivity to gemcitabine are excluded.
What is being tested?
The study tests the effectiveness of LY2880070 combined with chemotherapy drug gemcitabine in treating advanced Ewing sarcoma and related diseases. It aims to determine if this combination therapy can provide a new treatment option for patients who have not responded well to standard therapies.
What are the potential side effects?
Potential side effects may include reactions typical of chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Specific side effects from LY2880070 are not detailed but could resemble other targeted cancer drugs' profiles.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer did not respond to standard chemotherapy treatments.
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My cancer is a specific type called Ewing sarcoma, confirmed by a test.
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My cancer can be measured using standard criteria.
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I am mostly active and can care for myself.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any infections that are currently uncontrolled.
Select...
I have a history of heart issues including Torsades de Pointes, congestive heart failure, or a family history of prolonged QT syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Best overall response rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ewing sarcomaExperimental Treatment2 Interventions
Participants have a diagnosis of Ewing sarcoma as molecularly defined by an EWSR1 fusion with an ETS-transcription factor family member including FLI1, ERG, ETV1, ETV4, and FEV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Ewing Sarcoma include chemotherapy agents like gemcitabine, which incorporates into DNA and disrupts replication, leading to cell death. Novel agents like LY2880070, though not fully detailed, likely target specific pathways critical for cancer cell survival.
Other treatments, such as nab-paclitaxel, disrupt microtubule function, and PARP inhibitors like talazoparib enhance DNA damage. These mechanisms are vital for Ewing Sarcoma patients as they exploit the cancer's rapid cell division and genetic instability, potentially improving treatment efficacy and patient outcomes.
Vitamin E Phosphate Nucleoside Prodrugs: A Platform for Intracellular Delivery of Monophosphorylated Nucleosides.Synergistic activity of PARP inhibition by talazoparib (BMN 673) with temozolomide in pediatric cancer models in the pediatric preclinical testing program.Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP).
Vitamin E Phosphate Nucleoside Prodrugs: A Platform for Intracellular Delivery of Monophosphorylated Nucleosides.Synergistic activity of PARP inhibition by talazoparib (BMN 673) with temozolomide in pediatric cancer models in the pediatric preclinical testing program.Initial testing (stage 1) of the tubulin binding agent nanoparticle albumin-bound (nab) paclitaxel (Abraxane(®)) by the Pediatric Preclinical Testing Program (PPTP).
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,227 Total Patients Enrolled
Emily Slotkin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
534 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had no more than 4 cancer treatments and have waited the required time after my last treatment.My cancer did not respond to standard chemotherapy treatments.My cancer is a specific type called Ewing sarcoma, confirmed by a test.I have a history of heart issues including Torsades de Pointes, congestive heart failure, or a family history of prolonged QT syndrome.I weigh at least 40 kg.I can swallow pills.My cancer can be measured using standard criteria.I do not have any infections that are currently uncontrolled.I am mostly active and can care for myself.You are allergic to gemcitabine.My doctor thinks gemcitabine isn't right for my treatment.I have brain metastases but am not currently experiencing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Ewing sarcoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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