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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Childhood Burkitt Lymphoma

Childhood Central Nervous System Choriocarcinoma

Eligibility:

All Genders

1-21 years

Phase:

PHASE1

Brief Summary

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 tumo...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose and/or recommended phase II dose of vorinostat in combination with bortezomib in pediatric patients with refractory or recurrent solid t...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed solid tumors, including CNS tumors or lymphoma
  • Histological confirmation not required for the following diagnoses
  • Intrinsic brain stem tumors
  • Optic pathway gliomas
  • Pineal tumors and elevations of cerebral spinal fluid or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin, allowed
  • Relapsed or refractory disease
  • Must have measurable or evaluable tumor
  • No known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Karnofsky performance status (PS) 60-100% for patients \> 16 years of age OR Lansky PS60-100% for patients ≤ 16 years of age
  • Neurologic deficits inpatients with CNS tumors must have been relatively stable for a minimum of 1week
  • Patients who are unable to walk because ofparalysis, but who are up in a wheelchair, will be considered ambulatory for thepurpose of assessing the performance score
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions within the past 7 days)
  • Patients with known bone marrow metastatic disease allowed provided they meet the blood count criteria and are not known to be refractory to platelet transfusion
  • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions)
  • Patients with known bone marrow metastatic disease allowed provided they meet the blood count criteria and are not know to be refractory to RBC or platelet transfusion
  • Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age and/or gender as follows:
  • 6 mg/dL (1 to \< 2 years of age)
  • 8 mg/dL (2 to \< 6 years of age)
  • 0 mg/dL (6 to \< 10 years of age)
  • 2 mg/dL (10 to \< 13 years of age)
  • 5 (male) or 1.4 (female) (13 to \< 16 years of age)
  • 7 (male) or 1.4 (female) ( ≥ 16 years of age)
  • Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 times upper limit ofnormal
  • ALT ≤ 110 U/L
  • Serum albumin ≥ 2 g/dL
  • QTc interval ≤ 450 milliseconds
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be able to swallow capsules or liquids
  • Able to comply withthe safety-monitoring requirements of the study, in the opinion of the investigator
  • No peripheral neuropathy ≥ grade 2 within the past 14 days
  • No known hypersensitivity to vorinostat or bortezomib
  • No uncontrolled infection
  • No concurrent enzyme-inducing anticonvulsants
  • Must be recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
  • More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
  • At least 7 days since prior therapy with any of the following:
  • Hematopoietic growth factors
  • Biologic (anti-neoplastic) agent
  • For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
  • Corticosteroids unless on a stable or decreasing dose
  • At least 7 days or 3 half-lives, whichever is longer, since prior monoclonal antibodies
  • At least 2 weeks since prior local palliative radiotherapy (small port)
  • At least 6 months since prior total-body irradiation therapy, craniospinal radiotherapy, or ≥ 50% of pelvis irradiated
  • At least 6 weeks since prior substantial bone marrow radiotherapy
  • At least 3 months since prior stem cell transplantation or rescue and no evidence of active graft-vs-host disease
  • At least 2 weeks since prior and no concurrent valproic acid
  • At least 6 weeks since priorimmunotherapy (e.g., tumor vaccines)
  • No prior vorinostat
  • No other concurrent investigational drugs or other anticancer agents, including chemotherapy, radiotherapy, immunotherapy, or biologic therapy

Exclusion

    Key Trial Info

    Start Date :

    August 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    20 Patients enrolled

    Trial Details

    Trial ID

    NCT00994500

    Start Date

    August 1 2009

    Last Update

    July 2 2013

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Childrens Memorial Hospital

    Chicago, Illinois, United States, 60614

    2

    Dana-Farber Cancer Institute

    Boston, Massachusetts, United States, 02115

    3

    Columbia University Medical Center

    New York, New York, United States, 10032

    4

    Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, United States, 15224