Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma

Completed · Phase 1

Conditions studied: Recurrent Neuroblastoma, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID: NCT00075634
Run by: National Cancer Institute (NCI)
People needed: 21
Starts: 2003-12-01
Last updated by the study team: 2013-09-30

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed diagnosis of either of the following:
Solid tumor (part A)
No lymphoma
Neuroblastoma (part B)
Original diagnosis may be based on elevated urine vanillylmandelic acid (VMA) and homovanillic acid (HVA) and bone marrow examination
Accessible disease by bone marrow aspirate or tumor biopsy
No laparotomy, thoracotomy, endoscopy, or craniotomy for biopsy
No known curative therapy OR therapy proven to prolong survival with an acceptable quality of life available
No known brain or spinal cord metastases
No CNS tumors
Performance status - Karnofsky 50-100% (patients 11 to 21 years of age)
Performance status - Lansky 50-100% (patients ≤ 10 years of age)
Parts A and B without bone marrow infiltration:
Absolute neutrophil count ≥ 1,000/mm\^3
Platelet count ≥ 100,000/mm\^3 (transfusion independent)
Part B with bone marrow infiltration (i.e., tumor metastatic to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia):
Absolute neutrophil count ≥ 750/mm\^3
Platelet count ≥ 50,000/mm\^3 (transfusion independent)
Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
No sickle cell anemia
Bilirubin ≤ 1.5 mg/dL
ALT ≤ 5 times upper limit of normal
No significant hepatic dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results
Creatinine based on age as follows:
≤ 0.8 mg/dL (5 years of age and under)

Where it is running

Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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