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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT01625351
Eligibility Criteria:
Inclusion Criteria - Transplant Recipients:
* At least 2 years of age and less than or equal to 21 years of age.
* Histologically confirmed solid tumor or lymphoma at original diagnosis:
* Ewing Sarcoma Family of Tumors (ESFT)
* Gastrointestinal tumors
* Germ Cell tumors
* Hepatic tumors (including hepatocellular carcinoma and hepatoblastoma)
* Lymphoma (including Hodgkin and non-Hodgkin lymphoma)
* Kidney tumors (including Wilms tumor, rhabdoid tumors, clear cell carcinoma, and renal cell carcinoma)
* Melanoma
* Neuroblastoma
* Soft tissue sarcoma (including rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma)
* Malignancy has no reasonable expectation of cure with available alternative salvage therapy.
* Has a suitable human leukocyte antigen (HLA) haploidentical donor available.
* At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy.
* Has recovered from all acute NCI Common Toxicity Criteria grade II-IV acute non-hematologic toxicities from prior therapy per the judgment of the PI.
* Shortening fraction greater than or equal to 25%.
* Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 50 mL/min/1.73 m2.
* Pulse oximetry greater than or equal to 92% on room air
* Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to3 times the upper limit of the institution-established normal range.
* Direct bilirubin less than or equal to 3.0 mg/dL.
* Karnofsky or Lansky performance score of greater than or equal to 50.
Exclusion Criteria - Transplant Recipients:
* Newly diagnosed patients with no prior attempt at curative therapy.
* Any primary or active central nervous system (CNS) malignancy, including metastatic disease.
* Any active or prior malignant or pre-malignant condition of the bone marrow, excluding metastasis of the primary malignancy.
* Prior allogeneic hematopoietic stem cell transplant.
* Prior autologous stem cell transplant within previous 3 months.
* Allergy to murine products or positive human anti-mouse antibody (HAMA).
* (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
* (Female only) Breast feeding.
Inclusion Criteria - Donors:
* At least 18 years of age.
* Partially HLA matched family member.
* Human immunodeficiency virus (HIV) negative.
Exclusion Criteria - Donors:
* (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
* (Female only) Breast feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
21 Years
Study:
NCT01625351
Study Brief:
Protocol Section:
NCT01625351