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Status:

COMPLETED

Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

Boston Children's Hospital

Conditions:

Central Nervous System Tumor, Pediatric

Leukemia

Eligibility:

All Genders

Up to 21 years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as etoposide and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing....

Detailed Description

OBJECTIVES: Primary * Evaluate the activity of etoposide, cyclophosphamide, thalidomide, celecoxib, and fenofibrate, in terms of prolonging the time to disease progression, in young patients with re...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed cancer (at diagnosis or relapse), including any of the following:
  • Leukemia and/or lymphoma (closed to accrual)
  • Bone tumor (e.g., Ewing's sarcoma or osteosarcoma) (closed to accrual)
  • Neuroblastoma (closed to accrual)
  • High-grade glial tumor
  • Low-grade glial tumor
  • Ependymoma
  • Medulloblastoma and/or primitive neuroectodermal tumor (PNET)
  • Miscellaneous tumor (closed to accrual)
  • Brain stem glioma, defined as intrinsic tumors of the pons causing diffuse enlargement
  • Brain stem glioma that progressed after radiotherapy does not require histological confirmation
  • Duration of symptoms at the time of diagnosis must be \< 3 months
  • Symptoms should consist of cranial nerve deficits, ataxia, and/or long tract signs
  • Relapsed or progressive poor prognosis disease for which no available curative therapy exists
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 50-100% OR Lansky play scale 50-100% (for infants)
  • Life expectancy \> 2 months
  • Platelet count \> 75,000/mm\^3 (transfusion independent)
  • Absolute neutrophil count \> 1,000/mm\^3 (in patients without bone marrow disease)
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine \< 1.5 mg/dL OR creatinine clearance or glomerular filtration rate ≥ 70 mL/min
  • Bilirubin ≤ 1.5 mg/dL
  • SGPT ≤ 3 times normal
  • SGOT ≤ 3 times normal (4 times normal for patients on ranitidine hydrochloride)
  • Alkaline phosphatase ≤ 3 times normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception during and for 2 months after completion of study treatment
  • Must be willing to participate in the Celgene STEPS® program
  • Recent thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism) allowed if patient is clinically stable and the thromboembolic event occurred \> 3 weeks prior to study entry
  • No active infection
  • No active uncontrolled cardiac, hepatic, renal, or psychiatric disease ≥ grade 3
  • No known allergies to sulfonamides
  • No concurrent illness that would obscure toxicity or dangerously alter drug metabolism
  • No other serious medical illness
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from prior therapy
  • Prior chemotherapy and/or radiotherapy allowed
  • Prior celecoxib allowed
  • Prior standard-dose IV etoposide and cyclophosphamide administered in 3-week courses allowed
  • No prior oral therapy with etoposide, thalidomide, cyclophosphamide, or fenofibrate for \> 2 months in duration
  • No other concurrent investigational agents
  • No other concurrent nonsteroidal anti-inflammatory drugs
  • Concurrent steroids and/or antiseizure medications allowed

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2013

    Estimated Enrollment :

    101 Patients enrolled

    Trial Details

    Trial ID

    NCT00357500

    Start Date

    January 1 2005

    End Date

    December 1 2013

    Last Update

    October 1 2014

    Active Locations (10)

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

    Page 1 of 3 (10 locations)

    1

    Connecticut Children's Medical Center

    Hartford, Connecticut, United States, 06106

    2

    Miami Children's Hospital

    Miami, Florida, United States, 33155-4069

    3

    Children's Memorial Hospital - Chicago

    Chicago, Illinois, United States, 60614

    4

    Maine Medical Center Research Institute

    Scarborough, Maine, United States, 04074-7205