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 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT00036959
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed solid tumor\*, including, but not limited to, the following:
* Rhabdomyosarcoma
* Other soft tissue sarcomas
* Ewing's sarcoma family of tumors
* Osteosarcoma
* Neuroblastoma
* Wilms' tumor
* Hepatic tumors
* Germ cell tumors
* Primary brain tumors
* Brain stem or optic gliomas (histological confirmation may be waived if a biopsy has not been performed) NOTE: \*Closed to accrual for all diagnoses except neuroblastoma as of 4/16/05
* Relapsed after or failed to respond to frontline standard therapy and no other standard treatment options (e.g., surgery, radiotherapy, chemotherapy, or any combination of these modalities) exist
* Measurable or evaluable disease\* NOTE: \*Not required for patients with neuroblastoma
* No CNS tumor with motor or sensory deficits that would obscure the study assessment of sensory neuropathy
PATIENT CHARACTERISTICS:
Age:
* 18 and under
Performance status:
* Lansky 60-100% (age 10 and under)
* Karnofsky 60-100% (age 11 to 18)
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT and AST no greater than 2.5 times ULN (5 times ULN for patients treated after the maximum tolerated dose is determined)
* No clinically significant hepatic dysfunction
Renal:
* Creatinine normal for age OR
* Creatinine clearance at least 60 mL/min
* No clinically significant renal dysfunction
Cardiovascular:
* LVEF normal by echocardiogram
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No allergy to sulfa-containing medications
* No clinically significant unrelated systemic illness (e.g., other organ dysfunction) that would preclude study participation
* No serious infection
* No preexisting grade 2 or greater sensory or motor neuropathy
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 months since prior bone marrow transplantation
* At least 72 hours since prior interleukin-11
* At least 72 hours since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) except epoetin alfa
* No concurrent growth factors (e.g., GM-CSF) except epoetin alfa
* Concurrent G-CSF allowed if neutropenia lasts longer than 5 days OR if the patient experiences confirmed septicemia associated with neutropenia
* No concurrent immunotherapy
* No concurrent interleukin-11
Chemotherapy:
* See Disease Characteristics
* At least 30 days since prior chemotherapy (42 days for nitrosoureas)
* No other concurrent anticancer chemotherapy
Endocrine therapy:
* Patients with brain tumors:
* Must be on a stable or tapering dose of corticosteroids for 7 days before baseline scan performed for the purpose of assessing response to study therapy
* Concurrent corticosteroids allowed for control of symptoms of tumor-associated edema
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* At least 4 months since prior extensive radiotherapy (craniospinal radiotherapy, total body irradiation, or radiotherapy to more than 50% of the pelvis)
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
Other:
* Recovered from prior therapy
* At least 30 days since prior investigational anticancer therapy
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT00036959
Study Brief:
Protocol Section:
NCT00036959