Gefitinib in Treating Children With Refractory Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Childhood Solid Tumor, Protocol Specific
In brief
Phase I trial to study the effectiveness of gefitinib in treating children who have refractory solid tumors. Gefitinib may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth
Key facts
- Study ID
- NCT00040781
- Run by
- National Cancer Institute (NCI)
- People needed
- 45
- Starts
- 2002-06-01
- Last updated by the study team
- 2013-01-23
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed solid tumor at original diagnosis
- Refractory to conventional therapy and other therapies of higher priority according to the COG Phase I/II priority list or no conventional therapy exists
- No primary CNS tumors or known metastases to the CNS
- Performance status - Karnofsky 50-100% (over 10 years of age)
- Performance status - Lansky 50-100% (10 years of age and under)
- At least 8 weeks
- Absolute neutrophil count at least 1,000/mm\^3
- Platelet count at least 50,000/mm\^3 (transfusion independent)
- Hemoglobin at least 8.0 g/dL (RBC transfusion allowed)
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT no greater than 3 times ULN
- Albumin at least 2 g/dL
- Creatinine normal for age
- Glomerular filtration rate at least 70 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- At least 6 months since prior allogeneic stem cell transplantation (SCT)
- No evidence of active graft-versus-host disease
- At least 1 week since prior biologic agents
- At least 1 week since prior hematopoietic growth factors
- Recovered from prior immunotherapy
- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- No concurrent tamoxifen
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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