|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00923351 |
Purpose
Background:
Objectives:
-To determine whether immune therapy given after immune suppression can help the body fight the tumor and to determine the safety of the treatment.
Eligibility:
-Patients with Ewing's sarcoma, rhabdomyosarcoma or neuroblastoma whose disease has recurred after treatment or spread beyond the original site
Design:
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma Sarcoma Rhabdomyosarcoma-Embryonal Rhabdomyosarcoma- Alveolar Neuroectodermal Tumors, Primitive, Peripheral |
Drug: Tumor Purged/CD25 Depleted Lymphocytes Biological: Tumor Purged/CD25 Depleted Lymphocytes with Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine Drug: IL-4 Device: Miltenyi CliniMACS-System Drug: Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine Drug: KLH Drug: MAB 8H9 Drug: Endotoxin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Tumor Vaccination and R-hIL-7 Following Standard Multimodality Therapy in Patients With High Risk Pediatric Solid Tumors |
| Enrollment: | 44 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Background:
Objectives:
Eligibility:
Design:
Eligibility| Ages Eligible for Study: | 19 Months to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
A. Diagnosis
B. Extent of Disease/Previous Therapy
Recurrent Disease:
C. Age/Weight
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
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.
NCI Laboratory of Pathology will review all tumor specimens for diagnosis.
EXCLUSION CRITERIA: for Apheresis/Tumor biopsy portion of the trial:
A. Other conditions
INCLUSION CRITERIA: for Immunotherapy portion of the trial:
A. Informed Consent
Because significant time will have elapsed between apheresis/tumor biopsy and the initiation of immunotherapy, all patients or their legal guardians (if the patient is less than 18 years old) must sign a second 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).
B. Time and Recovery from Cytotoxic Therapy
At least 3 weeks should have elapsed since the last cycle of cytotoxic therapy or since the last dose of radiation therapy, at least 4 weeks must have elapsed since the patient has received any investigational therapy, and patients should have recovered from toxic side effects of previous therapy to a grade 1 or less, with the exception of the following:
C. Laboratory Parameters
D. Birth Control
Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
EXCLUSION CRITERIA: for Immunotherapy Portion of the Trial:
A. Other conditions
Excluded from Arm B:
Contacts and Locations| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | Crystal L Mackall, M.D. | National Cancer Institute (NCI) |
More Information
| Responsible Party: | Crystal L. Mackall, M.D./National Cancer Institute, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00923351 History of Changes |
| Obsolete Identifiers: | NCT00526240 |
| Other Study ID Numbers: | 070206, 07-C-0206 |
| Study First Received: | June 17, 2009 |
| Last Updated: | April 13, 2012 |
| Health Authority: | United States: Federal Government |
|
Vaccine Immunotherapy Cancer Chemotherapy Ewings Sarcoma |
Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine Neuroblastoma Autologous Lymphocyte Infusion Ewing's Sarcoma Rhabdomyosarcoma |
|
Neuroblastoma Rhabdomyosarcoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue |