Thalidomide and Temozolomide in Treating Young Patients With Relapsed or Progressive Brain Tumors or Recurrent Neuroblastoma

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital Boston
Celgene Corporation
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00098865
First received: December 8, 2004
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with temozolomide may kill more tumor cells.

PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide with temozolomide in treating young patients who have relapsed or progressive brain tumors or recurrent neuroblastoma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Neuroblastoma
Drug: temozolomide
Drug: thalidomide
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 Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Feasibility at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evidence of biologic activity as measured by radiographic response at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC 2.0 during treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Radiographic techniques as markers of tumor response as assessed by perfusion and diffusion MRI at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • In vitro correlative studies as markers of tumor response as assessed by urine and blood angiogenesis marker evaluation at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2002
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: temozolomide
    Dose escalation for tolerability
    Other Name: Temodar
    Drug: thalidomide
    Dosage changes by tolerability, given every night
    Other Name: Thalamid
Detailed Description:

OBJECTIVES:

Primary

  • Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas.

Secondary

  • Determine, preliminarily, biologic activity of this regimen in these patients.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive oral temozolomide on days 1-5 and oral thalidomide on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed* diagnosis of 1 of the following:

    • Poor prognosis brain tumor

      • Relapsed or progressive disease
      • No curative therapy exists
    • Neuroblastoma

      • Recurrent disease NOTE: *Histologic confirmation not required for brain stem glioma; patients with brain stem glioma must have clinical and radiographic evidence of disease
  • Patients with brain stem glioma must have symptoms lasting < 3 months comprising cranial nerve deficits (often VI or VII) and/or ataxia and/or long tract signs

PATIENT CHARACTERISTICS:

Age

  • 21 and under

Performance status

  • Karnofsky 50-100% OR
  • Lansky 50-100%

Life expectancy

  • More than 2 months

Hematopoietic

  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count > 75,000/mm^3
  • WBC > 2,000/mm^3
  • Absolute neutrophil count > 1,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • SGOT and SGPT ≤ 2 times normal (SGOT ≤ 4 times normal for patients taking Zantac)
  • Alkaline phosphatase ≤ 2 times normal
  • No active hepatic disease ≥ grade 3

Renal

  • Creatinine < 1.5 mg/dL OR
  • Creatinine clearance ≥ 70 mL/min
  • No active renal disease ≥ grade 3

Cardiovascular

  • No active cardiac disease ≥ grade 3

Pulmonary

  • No active pulmonary disease ≥ grade 3

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study participation

    • Willing and able to participate in the System for Thalidomide Education and Prescription Safety (S.T.E.P.S.^®) program
  • No active psychiatric disease ≥ grade 3

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed

    • No prior thalidomide

Chemotherapy

  • Prior chemotherapy allowed

    • No prior temozolomide

Endocrine therapy

  • Concurrent steroids allowed

Radiotherapy

  • Prior radiotherapy allowed

Surgery

  • Prior surgery allowed

Other

  • Concurrent antiseizure medications allowed
  • No other concurrent investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098865

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Children's Hospital Boston
Celgene Corporation
Investigators
Study Chair: Mark W. Kieran, MD, PhD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Mark W. Kieran, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00098865     History of Changes
Other Study ID Numbers: 01-279 DFCI, P30CA006516, CDR0000396780
Study First Received: December 8, 2004
Last Updated: July 6, 2011
Health Authority: United States: Federal Government

Keywords provided by Dana-Farber Cancer Institute:
recurrent neuroblastoma
childhood central nervous system germ cell tumor
childhood high-grade cerebral astrocytoma
childhood choroid plexus tumor
childhood craniopharyngioma
childhood infratentorial ependymoma
childhood grade I meningioma
childhood grade II meningioma
childhood grade III meningioma
childhood supratentorial ependymoma
recurrent childhood brain stem glioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood ependymoma
recurrent childhood medulloblastoma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood pineoblastoma

Additional relevant MeSH terms:
Brain Neoplasms
Nervous System Neoplasms
Neuroblastoma
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Thalidomide
Temozolomide
Dacarbazine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on July 29, 2014