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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT01204450
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed malignant solid tumor at original diagnosis, including the following:
* Neuroblastoma
* Bone sarcomas (primary neuroectodermal tumors/ Ewing sarcoma (PNET/ES), osteosarcoma)
* Soft tissue sarcomas (rhabdosarcoma and related tumors)
* Histologically confirmed of relapsed disease is highly recommended but not mandatory
* Measurable disease according to RECIST
* Refractory or progressive disease after ≥ 1 and ≤ 4 prior chemotherapy regimens
* Patients with neuroblastoma, PNET/ES, or rhabdosarcoma must have failed a cyclophosphamide/topotecan-containing regimen
* Stem cell transplantation, including preparative regimen and post-transplant immunotherapy, is considered to be 1 regimen
PATIENT CHARACTERISTICS:
* Karnofsky performance status (PS) 50-100% (or Lansky PS 50-100%)
* Life expectancy ≥ 8 weeks
* ANC ≥ 750/mm\^3
* Platelet count ≥ 75,000/mm\^3 (transfusion independent)
* Hemoglobin 8.0 g/dL (may receive RBC transfusions)
* Patients with tumor metastatic to bone marrow are allowed to receive transfusions to maintain hemoglobin and platelet counts
* Serum creatinine normal
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin \< 1.0 mg/dL (if total bilirubin \> 2.0 mg/dL)
* ALT \< 5 times ULN
* Negative pregnancy test
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Families must be able to give consent in English or Spanish
* No allergy to H1 antihistamines
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 2 weeks since prior chemotherapy, immunotherapy, or radiotherapy and recovered
* No concurrent anticonvulsants, including valproic acid
* No concurrent strong inducers or inhibitors of CYP3A4, including grapefruit juice
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT01204450
Study Brief:
Protocol Section:
NCT01204450