Completed PHASE2 INTERVENTIONAL 2-arm NCT00025363

Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma

A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Disease in Rhabdomyosarcoma and Related Tumors

Sponsor: National Cancer Institute (NCI)

Conditions Alveolar Childhood Rhabdomyosarcoma Embryonal Childhood Rhabdomyosarcoma Embryonal-botryoid Childhood Rhabdomyosarcoma Previously Treated Childhood Rhabdomyosarcoma Recurrent Childhood Rhabdomyosarcoma

Interventions cyclophosphamide doxorubicin hydrochloride etoposide filgrastim ifosfamide irinotecan hydrochloride laboratory biomarker analysis pharmacogenomic studies pharmacological study sargramostim tirapazamine vincristine sulfate

Updated 6 times since 2017 Last updated: Jan 16, 2013 Started: Nov 30, 2001 Primary completion: Oct 31, 2007

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Alveolar Childhood Rhabdomyosarcoma and Embryonal Childhood Rhabdomyosarcoma, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 6 data snapshots since 2001. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Feb 2017 — Jun 2018 [monthly]

Completed PHASE2

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Nov 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Arcadia, United States