Phase II Study of Valproate and Doxorubicin in Malignant Mesothelioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma

NCT00630409

Metastatic Renal Cell Carcinoma

COMPLETED PHASE2

Standard Chemotherapy With of Without Axitinib in Malignant Mesothelioma

NCT01211275

Malignant Pleural Mesothelioma

COMPLETED PHASE1/PHASE2

Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor

NCT00004243

Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE1

Feasibility Study of Adjuvant Treatment With S-1 and Oxaliplatin in Patients With Resectable Esophageal Cancer

NCT02347904

Esophageal Cancer

COMPLETED PHASE1

Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

NCT00690300

Pancreas Neoplasms

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Mesothelioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin

Group Type EXPERIMENTAL

Valproate plus doxorubicin

Intervention Type DRUG

Valproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valproate plus doxorubicin

Valproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No