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Phase I Trial of RAD001C (Everolimus) in Pediatric Patients With Recurrent Refractory Solid Tumors or Brain Tumors


Phase 1
3 Years
21 Years
Not Enrolling
Both
Tumors, Brain Tumors, Rhabdomyosarcoma, Sarcoma, Soft Tissue

Thank you

Trial Information

Phase I Trial of RAD001C (Everolimus) in Pediatric Patients With Recurrent Refractory Solid Tumors or Brain Tumors


Although a Phase II portion of this study was planned, it was never initiated.


Inclusion Criteria:



- Adequate performance status

- Adequate bone marrow, kidney, heart, and liver function

Exclusion Criteria:

- Must not be receiving concomitant anti-cancer treatment

- Must not be pregnant

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To find the highest dose of RAD001 that can be given to children with refractory or relapsing solid tumors, leukemias, or brain tumors without causing severe side effects

Outcome Time Frame:

Within 30 days per subject

Safety Issue:

Yes

Principal Investigator

Wayne L Furman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

RAD001

NCT ID:

NCT00187174

Start Date:

October 2004

Completion Date:

October 2008

Related Keywords:

  • Tumors
  • Brain Tumors
  • Rhabdomyosarcoma
  • Sarcoma, Soft Tissue
  • Brain tumors
  • Soft Tissue Sarcomas
  • Refractory solid tumors
  • Recurrent or Refractory Rhabdomyosarcomatous and Non-Rhabdomyosarcoma Soft Tissue Sarcomas
  • Brain Neoplasms
  • Rhabdomyosarcoma
  • Sarcoma

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794