Clinical trial · Interventional
Thalidomide in Combination With Temodar in Patients With Neuroendocrine Tumors
A Phase II Study of Thalidomide in Combination With Temodar in Patients With Metastatic Neuroendocrine Tumors
NCT00165230CI-TRIAL-00002259completedPhase 2ClinicalTrials.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)
The purpose of this study is to find out what effects, good or bad, that thalidomide and temodar have on patients with neuroendocrine tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumor | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temodar | Drug | Temozolomide | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the response rate in patients with locally unresectable neuroendocrine tumors treated with temodar and thalidomide.
Secondary outcomes (2)
- measure
- To evaluate overall response and progression free survival of this patient population
- measure
- to evaluate the safety of temodar and thalidomide.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma * Prior treatment with chemoembolization or cryotherapy is allowed * Radiotherapy is allowed if completed more than 4 weeks prior to study. * Measurable disease as defined by RECIST criteria * Age greater than or equal to 18 years. * ECOG performance status of less than or equal to 2 * ANC \>1,500/mm3 * Platelet Count \> 100,000/mm3 * Hemoglobin \> 9 g/dl * Serum creatinine \< 1.5 x ULN * Total bilirubin \< 2 x ULN * SGOT and SGPT \< 2 x ULN * Alkaline phosphatase \< 2 x ULN * Life expectancy of greater than 12 weeks Exclusion Criteria: * Clinically symptomatic central nervous system metastases or carcinomatous meningitis * Myocardial infarction in past 6 months * Major surgery in past two weeks * Uncontrolled serious medical or psychiatric illness * Insufficient recovery from all active toxicities of prior therapies * Active nonmalignant systemic disease * Frequent vomiting or medical condition that could interfere with oral medication intake * Known HIV positivity or AIDS-related illness * Pregnant or nursing women
References
Publications (0)
Data not yet available
No reference posted for this study.