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Monoclonal Antibodies

Chemotherapy Combo for Desmoplastic Small Round Cell Tumor

Phase < 1
Waitlist Available
Led By Emily Slotkin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed, previously untreated patients with histologically or molecularly confirmed DSRCT
Adequate renal function: Normal creatinine for age OR Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat DSRCT, a rare and aggressive cancer. The goal is to see if the new combo is effective and has fewer side effects.

Who is the study for?
This trial is for young patients (1-30 years old) with a rare cancer called Desmoplastic Small Round Cell Tumor who haven't had previous cancer treatments. They need to have good blood counts, controlled blood pressure, and proper liver, heart, and kidney function. Participants must not be pregnant or breastfeeding and should agree to use contraception.Check my eligibility
What is being tested?
The study tests adding irinotecan, temozolomide, and bevacizumab to the existing chemotherapy regimen for DSRCT. The goal is to assess the effects of this combination on both the patient's health and their response to the tumor treatment.See study design
What are the potential side effects?
Possible side effects include increased risk of bleeding or wound healing complications due to bevacizumab; digestive issues from irinotecan; fatigue and potential immune system impacts from temozolomide; as well as general chemotherapy-related side effects like nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been newly diagnosed with DSRCT and have not received any treatment.
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My kidney function is normal or nearly normal.
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My heart functions well, as confirmed by heart tests.
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I am between 1 and 29 years old.
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My blood tests show normal white cell and platelet counts.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To define adverse event profile
To define the tolerability
Secondary outcome measures
To assess use of 18FDG PET-CT
To estimate survival
To estimate the response rate of two cycles of irinotecan, temozolomide and bevacizumab
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ChemotherapyExperimental Treatment1 Intervention
This is a pilot study to evaluate the acute toxicities and activity of irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator based therapy in newly diagnosed patients with DSRCT.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,793 Total Patients Enrolled
4 Trials studying Desmoplastic Small Round Cell Tumor
350 Patients Enrolled for Desmoplastic Small Round Cell Tumor
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,665 Total Patients Enrolled
Emily Slotkin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
543 Total Patients Enrolled
4 Trials studying Desmoplastic Small Round Cell Tumor
350 Patients Enrolled for Desmoplastic Small Round Cell Tumor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate aim of this experiment?

"The primary objective of this two-year clinical trial is to evaluate the tolerability, while secondary outcomes include assessing time to progression and survival rates with irinotecan, temozolomide and bevacizumab treatment in patients with DSRCT. Additionally, 18FDG PET-CT will be used as an early indicator for response evaluation among those who have measurable or evaluable disease."

Answered by AI

Are seniors over 45 years of age able to participate in this trial?

"Participants in this trial must range from one year to 29 years of age. Seperately, there are 235 trials aimed at citizens below 18 and 1054 for those over 65."

Answered by AI

Has research been conducted to ascertain whether a combination of irinotecan, temozolomide and bevacizumab could augment the effects of high-dosage alkylator therapy?

"Presently, 738 trials evaluating the combination of irinotecan, temozolomide and bevacizumab with an alkylator-based regimen are still underway; 149 of these have progressed to Phase 3. The majority of sites conducting clinical research on this subject matter is located in Houston, Texas. Nevertheless, there are 27321 healthcare institutions around United States running experiments for irinotecan, temozolomide and bevacizumab incorporated into an existing schedule of high dose alkylator."

Answered by AI

What is the maximum capacity of people taking part in this research?

"At this time, recruitment for the aforementioned trial has concluded. The study was first posted on August 1st 2010 and last modified on September 1st 2022. For those seeking alternative studies; 451 trials are presently recruiting patients with sarcoma, as well 738 studies focusing on irinotecan, temozolomide and bevacizumab integrated into a pre-existing schedule of high dose alkylators have openings available."

Answered by AI

Might I have the opportunity to partake in this research project?

"This trial is seeking 15 patients, aged between 1 and 29 years old, with a new diagnosis of DSRCT. Additionally, candidates must have an Absolute Neutrophil Count at or above 1000/mm3; Platelet count higher than 100000/mytm3; Creatinine Clearance level significantly greater than 70ml/min/1.73 m2 ; Total Bilirubin under 1.5 times the ULN for age; AST not exceeding 2.5 times the ULN for age (with no evidence of hepatic involvement); normal cardiac function as measured by Shortening Fraction over 28% on e"

Answered by AI

What type of treatment regimen is irinotecan, temozolomide, and bevacizumab most frequently used to supplement high dose alkylator therapy?

"Soft tissue sarcoma (STS) typically responds to a treatment schedule incorporating irinotecan, temozolomide and bevacizumab alongside high dosage alkylators. This approach can also prove effective for other ailments such as recurrent platinum-sensitive epithelial ovarian cancer, malignant neoplasms and refractory Ewing sarcoma."

Answered by AI

Are there vacancies available to individuals looking to join the clinical trial?

"No, this clinical trial is not actively recruiting at the moment. Initially posted on August 1st 2010 and last edited September 1st 2022, it has since been closed for new participants. However, there are 1189 other trials that still require enrolment."

Answered by AI
~0 spots leftby Aug 2024