What is the mechanism of action of this treatment?

The most common treatments for Ewing Sarcoma include chemotherapy agents such as irinotecan and temozolomide, which work by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and leading to cell death. Additionally, investigational treatments like CDK4/6 inhibitors, such as abemaciclib, target specific proteins involved in cell cycle regulation. By inhibiting CDK4/6, these agents prevent cancer cells from progressing through the cell cycle, effectively halting their growth and proliferation. This is particularly important for Ewing Sarcoma patients as these treatments can potentially improve outcomes by targeting the cancer cells more precisely and reducing the likelihood of resistance to therapy.

What side effects are associated with this type of intervention?

Common treatments for Ewing Sarcoma include chemotherapy, radiation therapy, and surgery. Chemotherapy regimens often involve drugs like irinotecan and temozolomide, which can cause side effects such as nausea, vomiting, diarrhea, fatigue, and myelosuppression (decreased blood cell counts). Radiation therapy can lead to skin irritation, fatigue, and potential long-term effects on growth and development in children. For treatments similar to Abemaciclib, a CDK4/6 inhibitor, known side effects include neutropenia (low white blood cell count), diarrhea, fatigue, nausea, and abdominal pain. These side effects are important to consider when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

There are no specific mentions of FDA-approved drugs for Ewing Sarcoma in the provided context. However, investigational agents and clinical trials are highlighted, including the use of CDK4/6 inhibitors like Abemaciclib. The CAMPFIRE study is exploring the benefit of adding Abemaciclib to chemotherapy for recurrent or refractory Ewing Sarcoma. Other investigational drugs include those targeting the insulin-like growth factor 1 (IGF-1) receptor and various molecular targets. Participation in clinical trials is encouraged for patients with recurrent or advanced Ewing Sarcoma.

What other types of research exist?

Promising novel alternatives to Abemaciclib for Ewing Sarcoma patients include targeted therapies such as IGF-1R inhibitors (e.g., R1507), PARP inhibitors (e.g., Olaparib), and emerging immunotherapies like GD2-targeted CAR T-cell therapy. These therapies are currently being investigated in clinical trials and have shown potential in treating Ewing Sarcoma.

← Back to Search

Alkylating Agent

Abemaciclib + Chemotherapy for Sarcoma

Phase 2

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate hematologic and organ function ≤14 days prior to Day 1 of Cycle 1: Absolute neutrophil count ≥1000/µL, Platelets ≥75,000/mm³, Hemoglobin ≥8 g/dL, Total bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, Creatinine clearance or calculated GFR ≥60 mL/min/m² or serum creatinine based on age/gender, Female participants of childbearing potential must have a negative urine or serum pregnancy test, Body weight ≥10 kg

Stable or decreasing dose of steroids at least 7 days prior to enrollment

Must not have

Female participants who are pregnant or breastfeeding

Progression during prior treatment with irinotecan and/or temozolomide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to date of death due to any cause (estimated up to 45 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding a new drug called abemaciclib to standard cancer treatments can help children and young adults with Ewing's sarcoma that has come back or did not respond to previous treatments. Abemaciclib works by blocking proteins that help cancer cells grow, which may slow down or stop the tumor. Participation could last several months or more, depending on individual responses.

Who is the study for?

This trial is for individuals with Ewing's Sarcoma that has returned or didn't respond to treatment. They must have a measurable tumor, weigh at least 10 kg, and have adequate organ function. Participants need to be off previous cancer treatments for at least 7 days and recovered from their effects. Pregnant or breastfeeding women can't join, nor can those who've had certain surgeries recently or are dealing with severe infections like HIV.

What is being tested?

The study tests the effectiveness of adding abemaciclib to chemotherapy drugs irinotecan and temozolomide in treating Ewing's Sarcoma. It's part of a larger effort called CAMPFIRE designed to accelerate new cancer treatments for young people.

What are the potential side effects?

Possible side effects include nausea, vomiting, diarrhea (from irinotecan), fatigue, low blood cell counts leading to increased infection risk (from temozolomide), and potential liver issues (from abemaciclib). Each drug may cause other unique side effects as well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My steroid dose has been stable or decreasing for the last week.

Select...

My doctor expects me to live at least 8 more weeks and I can complete a treatment cycle.

Select...

I can swallow or have a tube for feeding.

Select...

I stopped all cancer treatments 7 days ago and have recovered from immediate side effects.

Select...

I can swallow pills without any issues.

Select...

I have been diagnosed with Ewing's sarcoma or a similar tumor.

Select...

My Ewing's sarcoma has not responded or has worsened after treatment.

Select...

I can commit to the study's duration and follow all its procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant or breastfeeding.

Select...

My condition worsened despite previous treatments with irinotecan or temozolomide.

Select...

I do not have any severe infections like HIV or hepatitis.

Select...

I have previously taken medication that targets CDK 4 and 6.

Select...

I have had a bone marrow or organ transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to date of death due to any cause (estimated up to 45 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to date of death due to any cause (estimated up to 45 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death due to any cause (estimated up to 45 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Abemaciclib Product Acceptability

Disease Control Rate (DCR)

Duration of Response (DoR)

+4 more

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490

91%

Diarrhoea

67%

Nausea

48%

Fatigue

45%

Decreased appetite

35%

Vomiting

27%

Anaemia

26%

Abdominal pain

23%

Asthenia

23%

Neutrophil count decreased

21%

Cough

20%

Constipation

20%

Headache

19%

Arthralgia

18%

White blood cell count decreased

18%

Neutropenia

15%

Alopecia

14%

Dry mouth

14%

Platelet count decreased

14%

Weight decreased

14%

Dysgeusia

13%

Dyspnoea

12%

Abdominal pain upper

12%

Back pain

12%

Dizziness

11%

Oedema peripheral

11%

Dyspepsia

11%

Pyrexia

11%

Blood creatinine increased

10%

Pain

Stomatitis

Aspartate aminotransferase increased

Thrombocytopenia

Lacrimation increased

Dehydration

Dry skin

Pruritus

Alanine aminotransferase increased

Flatulence

Upper respiratory tract infection

Urinary tract infection

Hypokalaemia

Chills

Musculoskeletal chest pain

Musculoskeletal pain

Anxiety

Gastrooesophageal reflux disease

Rash

Myalgia

Cellulitis

Pleural effusion

Atypical pneumonia

Gastroenteritis viral

Lung infection

Sepsis

Fall

Hip fracture

Pneumonitis

Pneumothorax

Febrile neutropenia

Respiratory tract infection

Haematotoxicity

Sinus bradycardia

Tachycardia

Large intestinal obstruction

Pancreatic enzyme abnormality

Pancreatitis

Varices oesophageal

Electrocardiogram abnormal

Liver function test abnormal

Renal function test abnormal

Bone pain

Muscular weakness

Acute kidney injury

Pulmonary embolism

Arterial thrombosis

Epilepsy

100%

80%

60%

40%

20%

Study treatment Arm

Abemaciclib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Irinotecan +TemozolomideExperimental Treatment2 Interventions

Irinotecan given IV and temozolomide orally.

Group II: Abemaciclib + Irinotecan +TemozolomideExperimental Treatment3 Interventions

Abemaciclib given orally in combination with irinotecan given IV and temozolomide given orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan

2017

Completed Phase 3

~2590

Abemaciclib

2019

Completed Phase 2

~1890

Temozolomide

2010

Completed Phase 3

~1880

0 / 14Eligibility criteria met

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

The most common treatments for Ewing Sarcoma include chemotherapy agents such as irinotecan and temozolomide, which work by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and leading to cell death. Additionally, investigational treatments like CDK4/6 inhibitors, such as abemaciclib, target specific proteins involved in cell cycle regulation. By inhibiting CDK4/6, these agents prevent cancer cells from progressing through the cell cycle, effectively halting their growth and proliferation. This is particularly important for Ewing Sarcoma patients as these treatments can potentially improve outcomes by targeting the cancer cells more precisely and reducing the likelihood of resistance to therapy.

The role of abemaciclib in treatment of advanced breast cancer.