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Alkylating agents
Irinotecan + Carboplatin for Rhabdomyosarcoma
Phase 2
Waitlist Available
Led By Leonard H. Wexler, 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 histologically-proven rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma confirmed by a MSKCC pathologist
Intermediate- or high-risk features including Stage 4 tumors, non-metastatic undifferentiated sarcoma, alveolar RMS, ectomesenchymoma with alveolar features, non-metastatic embryonal RMS, ectomesenchymoma with embryonal features, and specific criteria for patients ≥ 1 year of age with Stage 2 or 3 tumors
Must not have
Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of threatened airway or cord compromise)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying irinotecan and carboplatin to see how well they work together in treating patients with rhabdomyosarcoma.
Who is the study for?
This trial is for patients under 50 years old with newly diagnosed, untreated rhabdomyosarcoma or related sarcomas. They must have normal organ function, no prior chemotherapy or radiotherapy, and be willing to use contraception if of childbearing potential. It's aimed at those with intermediate-risk or high-risk features as specified in the study criteria.
What is being tested?
The trial is testing a combination of chemotherapy drugs irinotecan and carboplatin as first-line treatment for rhabdomyosarcoma. The goal is to see how well these drugs work together in stopping tumor growth by preventing cancer cells from dividing.
What are the potential side effects?
Chemotherapy drugs like irinotecan and carboplatin can cause side effects including nausea, vomiting, hair loss, low blood cell counts leading to increased infection risk and bleeding problems, kidney and liver issues, and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a new diagnosis of a specific muscle or soft tissue cancer, confirmed by a specialist.
Select...
My cancer is at an advanced stage or is a high-risk type.
Select...
I had a biopsy or surgery less than 42 days before starting treatment.
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I was diagnosed with my condition before turning 51.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had chemotherapy or radiotherapy, except for emergency treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: pts with intermediate- and high-risk rhabdomyosarcomaExperimental Treatment11 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
irinotecan hydrochloride
1999
Completed Phase 3
~3030
ifosfamide
1999
Completed Phase 3
~2230
conventional surgery
1994
Completed Phase 3
~13900
vincristine sulfate
1994
Completed Phase 3
~11270
radiation therapy
1994
Completed Phase 3
~13390
etoposide
1994
Completed Phase 3
~9300
filgrastim
1997
Completed Phase 3
~7260
carboplatin
2010
Completed Phase 3
~4790
cyclophosphamide
1994
Completed Phase 3
~8140
dexrazoxane hydrochloride
2005
Completed Phase 3
~2340
doxorubicin hydrochloride
1994
Completed Phase 3
~9590
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,965 Previous Clinical Trials
596,918 Total Patients Enrolled
70 Trials studying Sarcoma
13,766 Patients Enrolled for Sarcoma
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,963 Total Patients Enrolled
459 Trials studying Sarcoma
229,575 Patients Enrolled for Sarcoma
Leonard H. Wexler, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney, liver, heart, and blood tests are normal.My cancer is at an advanced stage or is a high-risk type.I have a new diagnosis of a specific muscle or soft tissue cancer, confirmed by a specialist.I am capable of understanding and agreeing to the study's procedures and risks.I had a biopsy or surgery less than 42 days before starting treatment.I have not had chemotherapy or radiotherapy, except for emergency treatment.I was diagnosed with my condition before turning 51.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: pts with intermediate- and high-risk rhabdomyosarcoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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