Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
Neuroblastoma · Sarcoma · Rhabdomyosarcoma-Embryonal · Rhabdomyosarcoma- Alveolar · Neuroectodermal Tumors, Primitive, Peripheral
Bottom Line
View on ClinicalTrials.gov: NCT00923351 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tumor Purged/CD25 Depleted Lymphocytes (Drug); Tumor Purged/CD25 Depleted Lymphocytes with Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine (Biological); rhIL-7 (Drug); Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine (Biological)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay |
0; 15 | 0.043 sig |
| PRIMARY Toxicity |
6; 24 | — |
| PRIMARY Overall Survival |
2.4; 4.3 | — |
Summary
Eligibility Criteria
- INCLUSION CRITERIA: for Apheresis/Tumor biopsy portion of the trial:
A. Diagnosis
- rhabdomyosarcoma: embryonal or alveolar.
- Ewing's sarcoma family of tumors (ESFT), which include: classical, atypical and extraosseous ESFT, peripheral primitive neuroectodermal tumors, peripheral neuroepithelioma, primitive sarcoma of bone, and ectomesenchymoma.
- neuroblastoma: may be diagnosed via histology or the standard clinical evidence for increased catecholamines in the urine plus tumor cells in the bone marrow.
- undifferentiated or embryonal sarcoma.
- desmoplastic small round cell tumor.
- synovial cell sarcoma.
B. Extent of Disease/Previous Therapy
- Initial presentation: Stage IV or metastatic disease, enrolled prior to any cytoreductive therapy.
- Recurrent Disease:
- Patient > 5yo must have recovered CD4 count to > 350 cells/mm^3 OR have disease free interval > one year from completion of cytotoxic therapy
- Patients 350 cells/mm^3 OR have disease free interval > six months from completion of cytotoxic therapy
- Multiple recurrences are allowable as long as CD4 count or disease-free intervals have been met.
C. Age/Weight
- greater than 18 mos. and less than or equal to 35 years at the time of initial diagnosis.
- greater than 10 kg at the time of apheresis. Patients between 10-15 kg must be approved by the apheresis unit prior to enrollment on protocol.
D. Informed Consent
All patients or their legal guardians (if the patient is less than 18 years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility. After confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility).
E. Laboratory Parameters
- renal function: creatinine clearance greater than 60 mL/min/1.73m^2 or normal age adjusted serum creatinine (less than or equal to 5 yrs. less than or equal to 0.8 mg/ml; 5-10 yrs. less than or equal to 1.0 mg/ml; 10-15 yrs. less than or equal to 1.2 mg/ml; greater than 15 yrs. less than or equal to 1.5 mg/ml)
- liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times upper limit of normal (ULN), bilirubin less than 1.5 ULN
- hematologic function: platelets greater than 50,000 cells/mcl, hemoglobin (Hgb) greater than 9.0 gms/dl, prothrombin time (PT) less than 1.5 ULN. Patients may receive transfusion if necessary to reach the pre-apheresis hematology parameters.
F. Accessibility of Tissue to Generate Tumor Lysates
Patients must have adequate tumor bulk accessible to biopsy in order to generate the tumor lysate (at least 2 cm diameter). Procedures employed to acquire biopsies for tumor lysates will be limited to percutaneous biopsies or open biopsies of readily accessible lesions. Patients should not undergo biopsies, which will later compromise the ability to render function preserving local therapy (e.g. limb salvage therapy). To prevent this, all bone biopsies should be performed in consultation with the orthopedic consultant on the case. For patients with bone marrow involvement, bone marrow aspirates may be used as a source of tumor for tumor lysates. Patients are not eligible if, in the opinion of the principal and associate investigators, tumor biopsy would entail extensive surgery such as thoracotomy or laparotomy, or if the tumor site places the patient at substantial risk from the biopsy procedure.
National Cancer Institute (NCI) Laboratory of Pathology will review all tumor specimens for diagnosis.
EXCLUSION CRITERIA: for Apheresis/Tumor biopsy portion of the trial:
A. Other conditions
- Clinically significant unrelated systemic illness, such as serious infections, autoimmunity or organ dysfunction, which in the j
Data sourced from ClinicalTrials.gov (NCT00923351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.