Clinical trial · Interventional
Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma
A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent Malignant Mesothelioma
NCT00634205CI-TRIAL-00016848completedPhase 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 determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .
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 |
|---|---|---|---|
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Valproate plus doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin
- interventionNames
- Drug: Valproate plus doxorubicin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Every 3 courses
Secondary outcomes (2)
- measure
- Survival
- timeFrame
- Survival will be dated from the day of registration until death or last follow up
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of malignant mesothelioma * Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin) * At least one evaluable or measurable CT-lesion * Availability for participating in the detailed follow-up of the protocol * Signed informed consent Exclusion Criteria: * Patients who are candidates for surgery with curative intent * Patient who were previously treated with anthracyclin derivatives * Performance status \< 60 on the Karnofsky scale * A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval) * A history of prior HIV infection * Polynuclear cells \< 2,000/mm³ * Platelet cells \< 100,000/mm³ * Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen * Serum bilirubin \>1.5 mg/100 ml * Transaminases more than twice the normal range * Serum creatinine \> 1.5 mg/100 ml * Recent myocardial infarction (less than 3 months prior to date of diagnosis) * Congestive cardiac failure (ejectional fraction of the left ventricle \< 50%) or uncontrolled cardiac arrhythmia * Uncontrolled infectious disease * Active epilepsy needing a specific treatment * Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine * Pregnancy or refusal to use active contraception * A known allergy to valproate acid and/or doxorubicin * Serious medical or psychological factors which may prevent adherence to the treatment schedule
References
Publications (1)
- DERIVEDScherpereel A, Berghmans T, Lafitte JJ, Colinet B, Richez M, Bonduelle Y, Meert AP, Dhalluin X, Leclercq N, Paesmans M, Willems L, Sculier JP; European Lung Cancer Working Party (ELCWP). Valproate-doxorubicin: promising therapy for progressing mesothelioma. A phase II study. Eur Respir J. 2011 Jan;37(1):129-35. doi: 10.1183/09031936.00037310. Epub 2010 Jun 7. PMID 20530048