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Alkylating agents

Irinotecan + Carboplatin for Rhabdomyosarcoma

Q: What are the primary ailments that irinotecan hydrochloride has been shown to be effective against?

<p>cancerous growths such as <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, neoplasm metastasis, and merkel cell <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> can be treated with irinotecan hydrochloride.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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I have a new diagnosis of a specific muscle or soft tissue cancer, confirmed by a specialist.

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My cancer is at an advanced stage or is a high-risk type.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Rate of local control

Response rate

Safety and feasibility

+1 more

Secondary outcome measures

Correlation of in vitro measurements of angiogenesis with clinical features (extent of disease), response to therapy, and outcome

Efficacy in terms of improved outcomes

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,557 Total Patients Enrolled

70 Trials studying Sarcoma

13,702 Patients Enrolled for Sarcoma

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,602 Total Patients Enrolled

453 Trials studying Sarcoma

230,034 Patients Enrolled for Sarcoma

Leonard H. Wexler, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00077285 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00077285 — Phase 2

Sarcoma Research Study Groups: pts with intermediate- and high-risk rhabdomyosarcoma

Sarcoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00077285 — Phase 2

Frequently Asked Questions

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

Does irinotecan hydrochloride have any long-term effects?

"There is currently some data suggesting that irinotecan hydrochloride is safe, but not enough to support efficacy. Therefore, it received a score of 2."

Answered by AI

Will this be the first time this particular clinical trial is conducted?

"2033 studies involving irinotecan hydrochloride are ongoing as of now. They span 86 countries and 3810 cities, with the first study dating back to 1997. Alfacell sponsored the initial 300-person Phase 3 drug approval trial, which was completed that year. Since then, 3307 more trials have been carried out."

Answered by AI

Does a body of research exist for irinotecan hydrochloride?

"Currently, there are 2033 clinical trials studying irinotecan hydrochloride. 468 of those active studies are in the last stage before FDA approval. The majority of these trials are taking place in Bethesda, Maryland; however, 84248 locations worldwide are running tests for this medication."

Answered by AI

Are new patients being enrolled in this clinical trial?

"This particular study is no longer looking for new patients as of their last update on November 1st, 2022. However, there are presently 484 other clinical trials actively recruiting patients with sarcoma and 2033 studies involving irinotecan hydrochloride that are still enrolling participants."

Answered by AI

What are the primary ailments that irinotecan hydrochloride has been shown to be effective against?

"cancerous growths such as leukemia, neoplasm metastasis, and merkel cell cancer can be treated with irinotecan hydrochloride."

Answered by AI

How many patients are part of this experiment?

"This study has stopped recruiting patients. Although the trial was last updated on November 1st, 2023, it originally started over 18 years ago on October 1st, 2003. However, there are currently 484 other studies actively looking for patients with sarcoma and 2033 studies for irinotecan hydrochloride that need participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma

2003. "Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00077285.

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