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Topoisomerase I Inhibitor

Olaparib + Temozolomide for Sarcoma

Phase 1

Waitlist Available

Led By Edwin Choy, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Presence of measurable disease

Histologically confirmed Ewing's sarcoma

Must not have

Symptomatic uncontrolled brain metastases

Major surgery within 14 days of starting study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Summary

This trial is testing the safety of an investigational drug combo and what dose is appropriate. The drugs in the combo work by interfering with cancer cells' ability to repair DNA and thus continue dividing.

Who is the study for?

This trial is for individuals with Ewing Sarcoma or Rhabdomyosarcoma who have already undergone at least one standard chemotherapy regimen. Participants must be willing to follow the study protocol, have measurable disease, and a life expectancy of at least 16 weeks. They should not be part of another clinical study within the last 21 days or have received certain treatments recently.

What is being tested?

The trial is testing different doses of Olaparib in combination with Temozolomide and/or Irinotecan to find the highest safe dose against Ewing's sarcoma and rhabdomyosarcoma. It's a Phase I study which means it's early in testing these drugs together for safety and appropriate dosage levels.

What are the potential side effects?

Potential side effects may include nausea, fatigue, blood disorders like anemia or low white cell counts (which can increase infection risk), digestive issues, neurological symptoms such as seizures if predisposed, allergic reactions to components of Olaparib or other drugs used.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be measured by tests.

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My diagnosis is Ewing's sarcoma.

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My Ewing's sarcoma has worsened despite having at least one standard chemotherapy.

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My insurance has approved temozolomide for the study period.

Exclusion Criteria

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

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I have brain metastases that are causing symptoms and are not under control.

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I have not had major surgery in the last 2 weeks.

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I have a serious health condition that is not under control.

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I am not taking certain fungal, antibiotic, or protease inhibitor medications.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I still have serious side effects from past cancer treatments.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

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I have active hepatitis B or C.

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I am HIV positive and on antiviral treatment.

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I have seizures that are not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Determine MTD of olaparib and irinotecan and/or temozolomide

Secondary study objectives

Evaluate safety and tolerability of olaparib/irinotecan and/or temozolomide combination

Explore variations in PARP activity and tumor characteristics

Neoplasms

Trial Design

3Treatment groups

Experimental Treatment

Group I: TwoExperimental Treatment3 Interventions

Olaparib, taken orally twice per day on days 1-7 (week 1) of each cycle Temozolomide, taken orally once per day on days 1-7 (week 1) of each cycle Irinotecan, given by IV once per day on days 1-7 of each cycle

Group II: ThreeExperimental Treatment2 Interventions

Olaparib, taken orally twice per day on days 1-7 (week 1) of each cycle Temozolomide, taken orally once per day on days 1-7 (week 1) of each cycle for patients with Rhabdomyosarcoma

Group III: OneExperimental Treatment2 Interventions

Olaparib, taken orally twice per day on days 1-7 (week 1) of each cycle Temozolomide, taken orally once per day on days 1-7 (week 1) of each cycle for patients with Ewing sarcoma

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Temozolomide

2010

Completed Phase 3

~1880

Irinotecan

2017

Completed Phase 3

~2580

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,993 Previous Clinical Trials

13,230,628 Total Patients Enrolled

Edwin Choy, MD, PhDPrincipal Investigator - Massachusetts General Hospital

Massachusetts General Hospital, Massachusetts General Physicians Organization Inc

New York University School Of Medicine (Medical School)

Brigham & Women'S Hospital (Residency)

3 Previous Clinical Trials

69 Total Patients Enrolled

Media Library

Irinotecan (Topoisomerase I Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01858168 — Phase 1

Ewing Sarcoma Research Study Groups: Two, Three, One

Ewing Sarcoma Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT01858168 — Phase 1

Irinotecan (Topoisomerase I Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01858168 — Phase 1

~1 spots leftby Nov 2024

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