At a glance
ClinicalIndex Comparison Record- ✓Relapsed or progressive poor prognosis brain tumor with no curative therapy available
- ✓Recurrent neuroblastoma
- ✓Brain stem glioma with clinical and radiographic evidence of disease and symptoms lasting <3 months (cranial nerve deficits, ataxia, or long tract signs)
- ✓Age ≤21 years
- ✕Prior thalidomide therapy
- ✕Prior temozolomide therapy
- ✕Active hepatic, renal, cardiac, or pulmonary disease ≥grade 3
- ✕Active psychiatric disease ≥grade 3
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma
In Brief
A Phase 2 clinical trial evaluating temozolomide and thalidomide for Central Nervous System Tumor, Pediatric and Neuroblastoma. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.