Clinical trial · Interventional
A Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
Anti-Angiogenic Chemotherapy: A Phase II Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
NCT00165451CI-TRIAL-00005182completedPhase 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)
This study will use a combination of four oral drugs (thalidomide, cyclophosphamide, etoposide and celecoxib) to treat patients with relapsed or progressive cancer. These drugs are expected to target the blood vessels that supply the tumors with what they need to grow.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the feasibility of administering thalidomide, celecoxib, etoposide and cyclophosphamide for recurrent and poor prognosis tumors.
- timeFrame
- 6 months
Secondary outcomes (3)
- measure
- To obtain preliminary evidence of biologic activity of these four orally administered
- timeFrame
- 6 months
- measure
- to evaluate and document side effects from chronic administration of these four drugs at the doses prescribed in this protocol
- timeFrame
- 6 months
- measure
- to evaluate different radiographic techniques as markers of tumor response.
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with relapsed or progressive poor prognosis tumors for which no curative therapy exists. * Histologic confirmation of disease at diagnosis or relapse. * Brain stem glioma patients who have progressed after radiation therapy do not require histologic confirmation. Duration of symptoms at the time of diagnosis must be less than 3 months and should consist of cranial nerve deficits and/or ataxia and/or long tract signs. * Prior radiation therapy and/or chemotherapy are permitted. * Karnofsky Performance Status \>50. For infants, the Lansky play scale \>50% can be substituted. * Life expectancy \> 2 months. * No active uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as ≥ grade 3 based on the common toxicity criteria. * No known allergies to sulfonamides * Adequate renal function: Serum Creatinine \< 1.5 mg/dl or creatinine clearance or GFR \> 70 ml/min. * Adequate hepatic function: Total Bilirubin \< 1.5 mg/dl; SGOT, SGPT, Alk Phos \< 3x normal.(SGOT can be \< 4x normal for patients on Zantac). * Adequate bone marrow reserve: Hgb \> 9.0 g/dl, Platelets \> 75,000/mm3 (transfusion independent),WBC \> 2000/mm3 and ANC \> 1000/mm3. * Patients receiving steroids and/or anti-seizure medications are eligible for this study. Exclusion Criteria: * Patients must not be pregnant or nursing, and all patients of child bearing age (both male and female) must be willing to practice birth control during and for 2 months after treatment with thalidomide. If the patient is unable to use oral contraceptives for medical reasons, 2 different barrier methods may be used if approved by the treating physician. * No concurrent use of other investigational agents. * Patients that have received more than 2 months of oral therapy with any of the agents used in this study will be ineligible. Standard administration of IV etoposide and cyclophosphamide, usually administered in 3-week cycles is permitted.
References
Publications (1)
- RESULTKieran MW, Turner CD, Rubin JB, Chi SN, Zimmerman MA, Chordas C, Klement G, Laforme A, Gordon A, Thomas A, Neuberg D, Browder T, Folkman J. A feasibility trial of antiangiogenic (metronomic) chemotherapy in pediatric patients with recurrent or progressive cancer. J Pediatr Hematol Oncol. 2005 Nov;27(11):573-81. doi: 10.1097/01.mph.0000183863.10792.d4. PMID 16282886