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Alkylating agents

Chemotherapy +/− Ganitumab for Ewing Sarcoma

Phase 3

Waitlist Available

Led By Steven G DuBois

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients with bone metastasis meeting specified criteria

Patients with histologic diagnosis of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site

Must not have

Patients with primary tumors arising in intra-dural soft tissue

Patients who have received prior chemotherapy or radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing how well combination chemotherapy works with or without the drug ganitumab in treating patients with newly diagnosed Ewing sarcoma.

Who is the study for?

This trial is for patients with newly diagnosed Ewing sarcoma that has spread, who haven't had prior chemotherapy or radiation. They must have a biopsy of the primary tumor and meet specific health criteria like normal kidney function, heart function, blood sugar levels, and liver enzymes. Pregnant or breastfeeding women are excluded, as well as those with diabetes or on long-term steroids.

What is being tested?

The study is testing if adding ganitumab to standard combination chemotherapy (vincristine, doxorubicin, cyclophosphamide, ifosfamide, etoposide) improves outcomes in metastatic Ewing sarcoma. Ganitumab targets the IGF-1R pathway which may help stop cancer growth. Patients are randomly assigned to receive either just chemo or chemo plus ganitumab.

What are the potential side effects?

Possible side effects include reactions at the injection site from ganitumab; nausea; hair loss; mouth sores; low blood cell counts leading to increased infection risk and bleeding problems from chemotherapy drugs; heart damage from doxorubicin; and kidney damage from ifosfamide.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has spread to my bones.

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I have been newly diagnosed with Ewing sarcoma or PNET with cancer spread to lungs, bones, or other areas.

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My lung nodules are considered as spread cancer based on certain criteria.

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My cancer has spread to my bone marrow, meeting specific conditions.

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I have enough tumor tissue for testing.

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My bilirubin levels are within the normal range for my age.

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I have only had a biopsy of my tumor, no surgery to remove it.

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My kidney function is normal or near normal.

Exclusion Criteria

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

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My cancer started in the soft tissues within the brain's protective layers.

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I have had chemotherapy or radiation therapy before.

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My cancer has spread only to the lymph nodes near the original tumor.

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I am a woman who can have children and do not have a negative pregnancy test result.

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I am sexually active and not using effective birth control.

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I am on long-term steroid medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Event-free Survival

Secondary study objectives

Frequency of Toxicity-events

Overall Survival

Other study objectives

Circulating Tumor DNA (ctDNA) Testing

EWS Translocation

Frequency of Resolution of Bone Marrow Metastases

+8 more

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702

32%

Fatigue

28%

Lymphocyte count decreased

24%

Cough

20%

Back pain

20%

Rash acneiform

16%

Anorexia

16%

Dry skin

16%

Hyperglycemia

16%

Rash maculo-papular

12%

Aspartate aminotransferase increased

12%

Non-cardiac chest pain

12%

Diarrhea

12%

Dyspepsia

12%

Headache

12%

Nausea

12%

Pain

12%

Pain in extremity

Urinary tract pain

Watering eyes

Weight loss

Myalgia

Wheezing

Arthralgia

Edema limbs

Abdominal pain

Paronychia

Pruritus

Blurred vision

Skin and subcutaneous tissue disorders - Other, specify

Upper respiratory infection

Vomiting

Urinary tract infection

White blood cell decreased

Lethargy

Sore throat

Skin infection

Urinary urgency

Insomnia

Infusion site extravasation

Ear pain

Oral hemorrhage

Conjunctivitis

Alkaline phosphatase increased

Blood bilirubin increased

Bone pain

Bruising

Depression

Dry eye

Dysgeusia

Dysphagia

Edema face

Epistaxis

Flashing lights

Flu like symptoms

Gastroesophageal reflux disease

Hot flashes

Hyperkalemia

Hypernatremia

Nail loss

Nail ridging

Neck pain

Neutrophil count decreased

Papulopustular rash

Platelet count decreased

Pneumonitis

Fracture

Fall

Skin hyperpigmentation

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Radiosurgery Followed by Erlotinib

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Regimen B (VDC/IE + ganitumab)Experimental Treatment12 Interventions

INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11. LOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy. CONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15. METASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT. MAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.

Group II: Regimen A (VDC/IE)Experimental Treatment11 Interventions

See Design Details.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Doxorubicin

2012