Trabectedin + Irinotecan for Ewing Sarcoma
(U01CA236220 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a combination of two drugs, trabectedin and irinotecan (also known as Camptosar or CPT-11), to treat Ewing sarcoma, a rare and aggressive cancer. The study aims to determine the effectiveness of these drugs, particularly in patients with a specific mutation called EWS-FLI1. Participants will undergo special PET scans to help researchers assess the treatment's progress. The trial seeks individuals with Ewing sarcoma that has returned or not responded to other treatments and who have a measurable tumor. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot be on other investigational drugs or anticancer agents. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining trabectedin and irinotecan yields promising results in treating Ewing sarcoma, a type of cancer. In one study involving patients who had already received multiple treatments, this combination helped shrink tumors in 5 out of 16 patients.
Earlier studies suggest that this treatment is generally safe, though side effects can occur, as with any cancer treatment. Participants should discuss potential risks and benefits with their doctors. The current phase of the trial aims to further assess the safety and effectiveness of this treatment.12345Why are researchers excited about this trial's treatments for Ewing sarcoma?
Researchers are excited about the combination of Trabectedin and Irinotecan for Ewing Sarcoma because this treatment approach uses a unique mechanism to target cancer cells. Unlike conventional options like chemotherapy with drugs such as Vincristine, Doxorubicin, and Cyclophosphamide, Trabectedin works by binding to the DNA of cancer cells, disrupting their replication process. This mechanism is different from most treatments that focus on stopping cell division. Additionally, the use of imaging scans in this treatment protocol allows doctors to better monitor how the cancer responds at an early stage, potentially leading to more tailored and effective treatments for patients.
What evidence suggests that trabectedin and irinotecan could be effective for Ewing sarcoma?
This trial will evaluate the combination of trabectedin and irinotecan for treating Ewing sarcoma, a rare cancer. Research has shown that using trabectedin and irinotecan together may help treat Ewing sarcoma. One study found that this combination was effective in patients who had already received extensive treatment, with several patients experiencing tumor shrinkage. Early research also suggests that these drugs work well together, boosting each other's effects on Ewing sarcoma cells. Trabectedin blocks a protein that aids cancer growth, while irinotecan attacks the cancer cells directly. This combination has stabilized the disease and reduced tumor activity.16789
Who Is on the Research Team?
Patrick Grohar, MD
Principal Investigator
Children's Hospital of Philadelphia
John Glod, MD/PhD
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
This trial is for patients with relapsed and refractory Ewing sarcoma, specifically the EWS-FLI1 fusion type. Participants must have measurable disease, be in a relatively stable condition (ECOG 0-2 or Lansky ≥50), and agree to undergo tumor biopsies. They should not be pregnant or breastfeeding, have no known therapy that prolongs survival, and must not have used certain drugs like trabectedin.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Trabectedin administered as a 1-hour infusion followed by irinotecan infusions on day 2 and day 4 of 21-day cycles
Phase II Treatment
Trabectedin and irinotecan combination treatment with 18F-FLT PET imaging to evaluate treatment effect
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Irinotecan
- Trabectedin
Trial Overview
The study tests trabectedin combined with irinotecan for treating Ewing sarcoma. It includes an infusion of a diagnostic agent (18F-FLT) followed by PET scans to assess treatment effects. The first phase has been completed; the second phase is now recruiting participants to further evaluate safety and efficacy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Trabectedin will be delivered by infusion on day 1 followed by 2 doses on irinotecan delivered by infusion for one hour on day 2 and day 4 of 21 day cycles. Some patients will receive an 18F-FLT Imaging scan prior to the first administration of trabectedin and once after administration of trabectedin.
Irinotecan is already approved in United States, European Union, Japan, Canada for the following indications:
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Small cell lung cancer
- Colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sarcoma Alliance for Research through Collaboration
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
National Institutes of Health (NIH)
Collaborator
Janssen Scientific Affairs, LLC
Industry Sponsor
Joaquin Duato
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Citations
SARC037: Phase II results of trabectedin given as a 1-hour ...
Conclusions: T+I exhibited anti-tumor activity in heavily pretreated pts with ES and met its prespecified ORR with 5 PRs in 16 evaluable ...
Trabectedin Followed by Irinotecan Can Stabilize Disease ...
Preclinical data indicate that trabectedin followed by irinotecan has strong synergistic effects on Ewing sarcoma. This is presumably due to ...
3.
aacrjournals.org
aacrjournals.org/clincancerres/article/21/6/1373/128472/Trabectedin-Efficacy-in-Ewing-Sarcoma-Is-GreatlyTrabectedin Efficacy in Ewing Sarcoma Is Greatly Increased ...
Results: We confirm that both trabectedin and doxorubicin were able to strongly reduce EWS–FLI1 (both type I and type II) binding to two representative target ...
4.
journals.biologists.com
journals.biologists.com/dmm/article/16/6/dmm049649/316733/Effectiveness-of-irinotecan-plus-trabectedin-on-aEffectiveness of irinotecan plus trabectedin on a ...
Vinorelbine, irinotecan and eribulin achieved nearly complete tumor growth inhibition (max TVI, 96-98%), although tumors regrew after the end of treatment. The ...
Trabectedin promotes oncolytic virus antitumor efficacy, ...
Trabectedin reduced enrichment of the virus-induced intracellular antiviral response in human Ewing sarcoma cells (Figure 2G). This decrease in ...
SARC037 Ewing Sarcoma Trial: Now recruiting for patients
A Phase I/II Study to Evaluate the Safety of Trabectedin Administered as a 1-Hour infusion in Ewing Sarcoma Patients in Combination with Low Dose Irinotecan.
Clinical Trial: NCT04067115 - Ewing Sarcoma
This study evaluates the trabectedin and irinotecan in the treatment of Ewings sarcoma, with a EWS-FLI1 mutation. Patients will also receive ...
8.
trial.medpath.com
trial.medpath.com/clinical-trial/5b54dd263536592d/nct04067115-safety-trabectedin-ewing-sarcomaA Phase I/II Study to Evaluate the Safety of Trabectedin in ...
Trabectedin and Irinotecan may inhibit the activity of this Ewing sarcoma mutation. Trabectedin may suppress the proliferation of the gene involved in DNA ...
Emerging therapies in Ewing sarcoma - PMC
Patients with recurrent or refractory disease have poor outcomes with a median overall survival of around 12 months [8]. Multiple regimens are ...
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