A Study of the Drugs Prexasertib Irinotecan and Temozolomide in People With Desmoplastic Small Round Cell Tumor and Rhabdomyosarcoma

  • STATUS
    Recruiting
  • End date
    Sep 15, 2022
  • participants needed
    30
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 15 May 2021
platelet count
renal function
cancer
measurable disease
glomerular filtration rate
schwartz
kidney function tests
metastasis
neutrophil count
irinotecan
cancer chemotherapy
temozolomide
antineoplastic
antibody therapy
myelosuppressive chemotherapy
desmoplastic
prexasertib

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 temozolomide. The study will test different doses of prexasertib in combination with irinotecan and temozolomide to find the highest dose of prexasertib that causes few or mild side effects in participants.

Details
Condition Desmoplastic Small Round Cell Tumor, Rhabdomyosarcoma, Sarcoma, Sarcoma (Pediatric), Soft Tissue Sarcoma
Treatment Irinotecan, Prexasertib
Clinical Study IdentifierNCT04095221
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on15 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
days must have elapsed after the last dose of cytotoxic or myelosuppressive chemotherapy
days must have elapsed after the last dose of anti-cancer agents not known to be myelosuppressive
days must have elapsed after radiation therapy, and toxicity related to prior radiation therapy must be recovered to grade 1
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 Criteria

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
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