Status:
COMPLETED
A Study of the Drugs Prexasertib, Irinotecan, and Temozolomide in People With Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Desmoplastic Small Round Cell Tumor
Rhabdomyosarcoma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to test whether the study drug prexasertib is a safe and effective treatment for people with DSRCT or RMS when given in combination with the standard drugs irinotecan and ...
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
- Age: patients must be ≥12 months of age at the time of study enrollment
- Diagnosis: patients must have histologically documented locally advanced or metastatic desmoplastic small round cell tumor or rhabdomyosarcoma (confirmed at MSK)
- Therapeutic options: patient's current disease state must be one which has failed standard therapy and for which there is no known curative therapy
- Disease Status: patients must have measurable disease based on RECIST 1.1
- Performance level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age
- Prior Therapy: patients may have had any number of prior therapies, but must have recovered from the acute toxic effects of all prior anti-cancer therapy (other than alopecia) as described below and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment
- °patients who have previously received irinotecan and/or temozolomide will be allowed
- 21 days must have elapsed after the last dose of cytotoxic or myelosuppressive chemotherapy
- 7 days must have elapsed after the last dose of anti-cancer agents not known to be myelosuppressive
- 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/mm\^3
- platelet count ≥ 100,000/ mm\^3
- hemoglobin ≥ 8 g/dl
- Adequate renal function defined as:
- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m2 OR
- Serum creatinine based on age/gender derived from the Schwartz formula for estimating GFR53
- Adequate liver function defined as:
- Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal for age
- 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:
- echocardiogram with left ventricular ejection fraction (LVEF) \>45%
- 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 participation
Exclusion
- Patients for whom the investigator deems that irinotecan and temozolomide are not appropriate are not eligible.
- Patients who have an uncontrolled infection are not eligible.
- Patients who are pregnant or breast feeding are not eligible.
- 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 are not eligible.
- Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible.
- Patients with known hypersensitivity to irinotecan or its excipients are not eligible.
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04095221
Start Date
September 17 2019
End Date
February 18 2025
Last Update
February 20 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065