Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
Condition: Central Nervous System Tumor, Pediatric; Neuroblastoma
MeSH terms: Neuroblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: temozolomide; thalidomide
Intervention description: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.; Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.
Intervention MeSH terms: Thalidomide; Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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