Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT00020150
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor refractory to standard therapy and for which no potentially curative therapy exists, including, but not limited to:
* Rhabdomyosarcoma and other soft tissue sarcomas
* Ewing's family of tumors
* Osteosarcoma
* Neuroblastoma
* Wilms' tumor
* Hepatic tumors
* Germ cell tumors
* Primary brain tumor
* Histological confirmation may be waived for brainstem or optic gliomas
* Measurable or evaluable disease
* Evidence of progressive disease on prior chemotherapy or radiotherapy or persistent disease after prior surgery
PATIENT CHARACTERISTICS:
Age:
* 21 and under
Performance status:
* ECOG 0-2
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute granulocyte count greater than 1,500/mm\^3
* Hemoglobin greater than 8 g/dL
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin normal
* SGPT less than 2 times upper limit of normal
* No significant hepatic dysfunction
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No significant cardiac dysfunction
Pulmonary:
* No significant pulmonary dysfunction
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to swallow capsules
* No significant unrelated systemic illness that would preclude study (e.g., serious infections or organ dysfunction)
* No prior hypersensitivity to dacarbazine, temozolomide, or polyethylene glycol
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G- CSF\], sargramostim \[GM-CSF\], or epoetin alfa)
* At least 4 months since prior myeloablative therapy requiring bone marrow or stem cell transplantation
* No concurrent anticancer immunotherapy
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
* Prior temozolomide allowed provided not administered within past 3 months, no severe toxicities experienced during prior course, and not given in combination with other agents designed to inactivate alanine-glyoxylate aminotransferase
* No other concurrent investigational or standard anticancer chemotherapy
Endocrine therapy:
* Concurrent corticosteroids for control of brain tumor-associated edema allowed provided on stable or decreasing dose for at least 1 week prior to study
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior limited-field radiotherapy
* At least 4 months since prior craniospinal irradiation, total body irradiation, or radiotherapy to more than half of the pelvis
* Recovered from prior radiotherapy
* No concurrent anticancer radiotherapy
Surgery:
* See Disease Characteristics
Other:
* At least 4 weeks since other prior investigational therapy and recovered
* No other concurrent anticancer investigational agents
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00020150
Study Brief:
Protocol Section:
NCT00020150