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A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma


Phase 2
N/A
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Neuroblastoma

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Trial Information

A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility at 6 months

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Mark W. Kieran, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

01-279 DFCI

NCT ID:

NCT00098865

Start Date:

September 2002

Completion Date:

December 2010

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • 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
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms

Name

Location

Dana Farber Cancer InstituteBoston, Massachusetts  02115