Phase 2
N=15
Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
Central Nervous System Tumor, Pediatric · Neuroblastoma
Bottom Line
View on ClinicalTrials.gov: NCT00098865 ↗Enrolled (actual)
15
Serious AEs
60.0%
Results posted
Sep 2014
Primary outcome: Primary: Therapy Completion Rate — .40 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- temozolomide (Drug); thalidomide (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapy Completion Rate |
.40 | — |
| SECONDARY Overall Response |
1; 9; 4; 1 | — |
| SECONDARY Overall Survival |
12.8 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00098865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.