Vorinostat and Bortezomib in Treating Young Patients With Refractory or Recurrent Solid Tumors, Including Central Nervous System Tumors and Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00994500
Phase
PHASE1
Status
Completed

Conditions

  • Childhood Burkitt Lymphoma
  • Childhood Central Nervous System Choriocarcinoma
  • Childhood Central Nervous System Germ Cell Tumor
  • Childhood Central Nervous System Germinoma
  • Childhood Central Nervous System Mixed Germ Cell Tumor
  • Childhood Central Nervous System Teratoma
  • Childhood Central Nervous System Yolk Sac Tumor
  • Childhood Choroid Plexus Tumor
  • Childhood Craniopharyngioma
  • Childhood Diffuse Large Cell Lymphoma
  • Childhood Immunoblastic Large Cell Lymphoma
  • Childhood Medulloepithelioma
  • Childhood Meningioma
  • Childhood Mixed Glioma
  • Childhood Nasal Type Extranodal NK/T-cell Lymphoma
  • Childhood Oligodendroglioma
  • Recurrent Childhood Anaplastic Large Cell Lymphoma
  • Recurrent Childhood Brain Stem Glioma
  • Recurrent Childhood Central Nervous System Embryonal Tumor
  • Recurrent Childhood Cerebellar Astrocytoma
  • Recurrent Childhood Cerebral Astrocytoma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Grade III Lymphomatoid Granulomatosis
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Malignant Germ Cell Tumor
  • Recurrent Childhood Medulloblastoma
  • Recurrent Childhood Pineoblastoma
  • Recurrent Childhood Small Noncleaved Cell Lymphoma
  • Recurrent Childhood Subependymal Giant Cell Astrocytoma
  • Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
  • Recurrent Childhood Visual Pathway Glioma
  • Recurrent Childhood Visual Pathway and Hypothalamic Glioma
  • Recurrent/Refractory Childhood Hodgkin Lymphoma
  • Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    Given orally
  • bortezomib — DRUG
    Given IV
  • pharmacological study — OTHER
    Correlative studies
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase I trial is studying the side effects and best dose of vorinostat when given together with bortezomib in treating young patients with refractory or recurrent solid tumors, including CNS tumors and lymphoma. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Key Dates

Start date
Aug 31, 2009
Status verified
Jul 2013
Primary completion
Jul 31, 2011

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (vorinostat, bortezomib)
    Patients receive oral vorinostat once daily on days 1-5 and 8-12 and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum-tolerated dose defined as the maximum dose at which fewer than one-third of patients experience DLT according to NCI CTCAE version 3.0 [ Time Frame: 21 days ]

Locations (6)

FacilityCityStateZIPSite coordinators
Childrens Memorial HospitalChicagoIllinois60614-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Columbia University Medical CenterNew YorkNew York10032-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
St. Jude Children's Research HospitalMemphisTennessee38105-
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Chicago, IL

By research site
Childrens Memorial Hospital· Chicago, ILDana-Farber Cancer Institute· Boston, MAColumbia University Medical Center· New York, NYChildren's Hospital of Pittsburgh of UPMC· Pittsburgh, PASt. Jude Children's Research Hospital· Memphis, TNBaylor College of Medicine· Houston, TX

Related Studies