Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
NCT00075634 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2013-09-30
Summary
This phase I trial is studying the side effects and best dose of decitabine when given together with doxorubicin and cyclophosphamide in treating children with relapsed or refractory solid tumors or neuroblastoma. Drugs used in chemotherapy, such as decitabine, doxorubicin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
Conditions
- Recurrent Neuroblastoma
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
- DRUG
-
decitabine
Given IV
- DRUG
-
doxorubicin hydrochloride
Given IV
- DRUG
-
Given IV
- BIOLOGICAL
-
Given SC
- BIOLOGICAL
-
Given SC
- OTHER
-
laboratory biomarker analysis
Correlative studies
- OTHER
-
pharmacological study
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Rani George · COG Phase I Consortium
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Year
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-12-31
- Primary Completion
- 2007-09-30
Countries
- United States
Study Locations
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