Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors
Previously Treated Childhood Rhabdomyosarcoma, Recurrent Childhood Brain Tumor, Recurrent Childhood Cerebellar Astrocytoma
About this trial
This is an interventional treatment trial for Previously Treated Childhood Rhabdomyosarcoma
Eligibility Criteria
Inclusion Criteria: 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 Negative pregnancy test Fertile patients must use effective contraception Able to swallow tablets (for patients in part 2 only) No uncontrolled infection Recovered from all prior immunotherapy At least 7 days since prior biologic therapy At least 3 months since prior stem cell transplantation and no evidence of active graft-versus-host disease More than 1 week since prior growth factors No concurrent prophylactic growth factor therapy No concurrent immunotherapy No concurrent biologic therapy More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered No other concurrent chemotherapy No concurrent systemic corticosteroids except for treatment of increased intracranial pressure or symptomatic tumor edema in patients with CNS tumors No concurrent steroids as an antiemetic Concurrent dexamethasone for patients with CNS tumors allowed provided patient has been on a stable or decreasing dose for at least 1 week before study entry Recovered from all prior radiotherapy At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks since prior substantial bone marrow irradiation At least 6 months since prior craniospinal radiotherapy At least 6 months since prior radiotherapy to 50% or more of the pelvis At least 8 weeks since prior standard-fraction radiotherapy for patients with recurrent brain tumors unless there is biopsy proof of recurrent tumor Prior radiosurgery within the past 9 months allowed provided there is documentation of progressive disease by biopsy, positron-emission tomography (PET) scan, or MR spectroscopy No concurrent radiotherapy More than 1 week since prior CYP3A4 inhibitors More than 4 weeks since prior CYP3A4 inducers More than 5 days since prior proton-pump inhibitors More than 2 days since prior H_2 blockers No prior erlotinib No concurrent enzyme-inducing anticonvulsants No concurrent proton-pump inhibitors No concurrent H2 blockers No other concurrent investigational agents Concurrent antacids allowed provided the antacid is not administered 2 hours before, during, and 2 hours after erlotinib administration
Sites / Locations
- COG Phase I Consortium
Arms of the Study
Arm 1
Experimental
Treatment (erlotinib hydrochloride, temozolomide)
Patients receive oral erlotinib once daily on days 1-28. Beginning with course 2, patients also receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 23 courses in the absence of disease progression or unacceptable toxicity.