Clinical trial
clinical trial
Evaluate novel agents with intensive multi-agent interval compressed reaction for high-risk rhabdomyosarcoma
Intervention
Drug intervention
Intervention Type
drug intervention
has_intervention
Cixutumumab
drug intervention
Cixutumumab
Intervention
intervention
planned process
planned process
process
occurrent
entity
Drug intervention
drug intervention
Temozolomide
drug intervention
Temozolomide
Intervention
intervention
planned process
planned process
process
occurrent
entity
Drug intervention
drug intervention
Vincristine/irinotecan
drug intervention
Vincristine/irinotecan
Intervention
intervention
planned process
planned process
process
occurrent
entity
Contact
has contact
has_contact
Berenberg, Jeffrey
PI
has PI
has_PI
Wilkinson, Robert, M.D.
Topic
has topic
has_topic
rhabdomyosarcoma
Funded by
funded by
funded_by
Children's Oncology Group
Phase
Phase 0 clinical trial
has phase
has_phase
Phase 0
Performed by
human study performed by
human_study_performed_by
Clinical Protocol & Data Management Shared Resource
Antineoplastic combined chemotherapy
Additional Topic(s)
has_subject_area
This trial evaluates the addition of novel therapeutic agents to the intensive chemotherapy used in the previous COG trial for metastatic rhabdomyosarcoma. As in the previous trial, patients enrolled in this study will be treated with an intensified chemotherapy regimen. This study will assess the feasibility of adding new agents to the chemotherapy backbone. Patients in Pilot 1 will have cixutumumab added to their weekly chemotherapy. Patients in Pilot 2 will have temozolomide added to their vincristine/irinotecan cycles. Patients in Pilot 3 will receive both cixutumumab and temozolomide with the chemotherapy.
Resource Description
resource_description
Patients must have newly diagnosed (within 42 days of enrollment), biopsy-confirmed metastatic rhabdomyosarcoma (RMS) or ectomesenchymoma, including the following: Embryonal RMS (for patients 10 to 49 years of age) ; Alveolar RMS or ectomesenchymoma (for patients under 50 years of age)
Study Population
study population
has_study_population
2011-06-27T18:05:49.138-05:00
awendicke (Annemarie Wendicke)
2011-09-23T10:55:28.403-05:00
workflow state
Published
mwilson (Melanie Wilson)
nvasilevsky
Interventional study
Research project
research project
Human Study
human study
human study
planned process
planned process
Quantitative human study
process
occurrent
entity