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:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT00024258
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:
* Ewing's family of tumors/primitive neuroectodermal tumor
* Retinoblastoma
* Nephroblastoma
* Osteosarcoma
* Rhabdomyosarcoma
* Desmoplastic small round-cell tumor
* Hepatoblastoma
* Germ cell tumors
* Medulloblastoma
* Relapsed from or resistant to prior standard anticancer therapy and/or no known standard therapy available
* Measurable disease (e.g., solid mass with definable dimensions) OR
* Evaluable disease (e.g., bone marrow involvement or malignant pleural effusion)
PATIENT CHARACTERISTICS:
Age:
* 40 and under
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.5 times upper limit of normal (ULN)
Renal:
* Creatinine no greater than 2.5 times ULN
Cardiovascular:
* Absolute QT interval no greater than 460 msec in the presence of adequate potassium and magnesium levels
Other:
* No pre-existing neurotoxicity/neuropathy grade 2 or greater
* No pre-existing convulsive disorder
* No active serious infections uncontrolled by antibiotics
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* More than 3 weeks since prior cytotoxic chemotherapy
* No other concurrent cytotoxic chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Concurrent radiotherapy allowed provided measurable or evaluable disease exists outside radiation field
Surgery:
* Not specified
Other:
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
40 Years
Study:
NCT00024258
Study Brief:
Protocol Section:
NCT00024258