Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors
Completed · Phase 1
Conditions studied: Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Brain Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Medulloblastoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma
In brief
This phase I trial is studying the side effects and best dose of erlotinib when given with temozolomide in treating young patients with recurrent or refractory solid tumors. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving erlotinib with temozolomide may kill more tumor cells.
Key facts
- Study ID
- NCT00077454
- Run by
- National Cancer Institute (NCI)
- People needed
- 95
- Starts
- 2004-02-01
- Last updated by the study team
- 2013-06-05
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- One of the following histologically confirmed solid tumors:
- Brain tumors
- Osteogenic sarcoma
- Rhabdomyosarcoma
- Soft tissue sarcoma (excluding Ewing's sarcoma)
- Neuroblastoma
- Germ cell tumors
- Recurrent or refractory disease
- No known curative therapy exists
- Performance status - Karnofsky 50-100% (for patients age 11 to 21)
- Performance status - Lansky 50-100% (for patients age 10 and under)
- At least 8 weeks
- Absolute neutrophil count > 1,000/mm\^3
- Platelet count > 100,000/mm\^3 (transfusion independent*)
- Hemoglobin > 8.0 g/dL (transfusion allowed)
- Bilirubin < 1.5 times upper limit of normal (ULN)
- ALT < 2.5 times ULN
- Albumin ≥ 2 g/dL
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- Creatinine based on age as follows:
- ≤ 0.8 mg/dL for patients age 5 and under
- ≤ 1.0 mg/dL for patients 6 to 10
- ≤ 1.2 mg/dL for patients 11 to 15
- ≤ 1.5 mg/dL for patients age 15 to 21
- Not pregnant or nursing
Where it is running
- COG Phase I Consortium — Arcadia, California, United States
Full record on ClinicalTrials.gov
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