Clinical trial · Interventional
Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma
NCT00098865CI-TRIAL-00015788completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Tumor, Pediatric | Childhood Central Nervous System Neoplasm | ALIAS | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thalidomide and Temozolomide
- description
- Thalidomide: Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated. Temozolomide: Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation. Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
- interventionNames
- Drug: temozolomide
- Drug: thalidomide
Primary outcomes (1)
- measure
- Therapy Completion Rate
- timeFrame
- 6 months
- description
- Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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 agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.