Sarcoma Clinical Trial
Official title:
Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation With Myeloablative Chemotherapy (Thiotepa, Etoposide and Carboplatin) and Autologous Stem Cell Rescue
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of different regimens of combination
chemotherapy followed by peripheral stem cell transplantation in treating children who have
newly diagnosed brain tumor.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 10 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed malignant, newly diagnosed brain tumor Regimen A: - Posterior fossa medulloblastoma/primitive neuroectodermal tumor (PNET): - All stages, under 3 years at diagnosis OR - High stage (local residual tumor postoperatively and/or neuraxis or extraneural dissemination), 3-10 years at diagnosis - Supratentorial PNET, pineoblastoma, cerebral neuroblastoma, ependymoblastoma, medulloepithelioma, medullomyoblastoma: - All stages, under 10 years at diagnosis - Brainstem PNET: - All stages, irrespective of extent of resection, under 10 years at diagnosis - Ependymoma or anaplastic ependymoma: - All stages, any location (except primary spinal cord ependymoma), under 3 years at diagnosis OR - Local residual tumor postoperatively and/or neuraxis dissemination, any location, 3-10 years at diagnosis - Supratentorial ependymoma: - All stages, irrespective of extent of resection, under 10 years at diagnosis, excluding gross totally resected (confirmed by postoperative MRI) low grade ependymoma not invading the ventricular system - Metastatic retinoblastoma: - Previously untreated (except for cryosurgery or laser surgery), under 10 years at presentation of metastatic disease - Primary atypical teratoid/rhabdoid tumors of the CNS: - Under 10 years at diagnosis - Choroid plexus carcinoma: - Incompletely resected, all sites, under 10 years at diagnosis Regimen C: - Anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, anaplastic ganglioglioma, other anaplastic mixed gliomas: - Under 10 years at diagnosis - Diffuse intrinsic pontine tumors: - Unbiopsied, under 10 years at diagnosis The following diagnoses are not eligible: - Myxopapillary ependymoma of the spinal cord, low grade brainstem astrocytoma, primary CNS lymphoma or solid leukemic lesion (i.e., chloroma, granulocytic sarcoma), or primary CNS germ cell tumor PATIENT CHARACTERISTICS: Age: - Under 10 at diagnosis Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 1.5 mg/dL - SGPT less than 2.5 times upper limit of normal Renal: - Creatinine clearance greater than 60 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Prior corticosteroids allowed - No concurrent corticosteroids for the sole purpose of antiemesis Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics - Recovered from prior surgery |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Children's Hospital | Buenos Aires | |
Canada | British Columbia Children's Hospital | Vancouver | British Columbia |
United States | Albert Einstein Clinical Cancer Center | Bronx | New York |
United States | Spectrum Health and DeVos Children's Hospital | Grand Rapids | Michigan |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin |
United States | Winthrop University Hospital | Mineola | New York |
United States | Beth Israel Hospital North | New York | New York |
United States | Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York |
United States | Children's Hospital of Omaha | Omaha | Nebraska |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Maine Children's Cancer Program | Scarborough | Maine |
United States | State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York |
United States | State University of New York - Upstate Medical University | Syracuse | New York |
United States | St. Vincent Mercy Medical Center | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States, Argentina, Canada,
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04457258 -
68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
|
Early Phase 1 | |
Recruiting |
NCT04986748 -
Using QPOP to Predict Treatment for Sarcomas and Melanomas
|
||
Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Recruiting |
NCT04535713 -
GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
|
Phase 2 | |
Completed |
NCT03521531 -
Burden and Medical Care of Sarcoma in Germany
|
||
Completed |
NCT02496520 -
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
|
Phase 1/Phase 2 | |
Terminated |
NCT02054104 -
Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum
|
Phase 1/Phase 2 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT04577014 -
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
Completed |
NCT04052334 -
Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma
|
Phase 1 | |
Completed |
NCT01593748 -
A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
|
Phase 2 | |
Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
Recruiting |
NCT04367779 -
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
|
||
Completed |
NCT01879085 -
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04553692 -
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
|
Phase 1 | |
Completed |
NCT01209598 -
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
|
Phase 2 | |
Completed |
NCT04553471 -
Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
|
N/A | |
Withdrawn |
NCT04906876 -
A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
|
Phase 2 |