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Alkylating agents

Induction Combination Chemotherapy for Mesothelioma

Phase 2

Waitlist Available

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to initiation of each cycle of therapy, and every 3 months after completion of therapy until death, withdrawal or loss to follow up (average 10 years)

Awards & highlights

Study Summary

This trial is studying combination chemotherapy with or without surgery and chemoradiotherapy to see how well it works in treating patients with malignant pleural mesothelioma.

Eligible Conditions

Mesothelioma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to initiation of each cycle of therapy, and every 3 months after completion of therapy until death, withdrawal or loss to follow up (average 10 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to initiation of each cycle of therapy, and every 3 months after completion of therapy until death, withdrawal or loss to follow up (average 10 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to initiation of each cycle of therapy, and every 3 months after completion of therapy until death, withdrawal or loss to follow up (average 10 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Response

Secondary outcome measures

Assess Patient Quality of Life

Relapse free and overall survival

Tolerability and toxicity

Trial Design

1Treatment groups

Experimental Treatment

Group I: Induction Combination ChemotherapyExperimental Treatment8 Interventions

Induction chemotherapy: Patients get MVP chemo. Treatment repeats every 28 days for 2 courses. Patients w/ unresectable disease may get up to 2 add'l courses of induction chemo. Patients requiring palliative radiotherapy or have PD are removed from study. Patients w/ resectable disease or sarcomatoid histology & T1-3, N1-2 disease w/ a CR or PR to induction chemo go to surgery. Surgery: Patients w/ extensive disease get palliative debulking pleurectomy and decortication & are taken off study. Other patients undergo a thoracotomy w/ extrapleural pneumonectomy & proceed to chemoradiotherapy. Chemoradiotherapy: At 6-10 weeks post-op, patients get 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients receive cisplatin IV over 30-60 minutes days 1 & 22. Patients w/ responding disease proceed to adjuvant chemotherapy. Adjuvant chemotherapy: Patients get 2 more courses of MVP chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Methotrexate

2013

Completed Phase 4

~3800

Vinorelbine ditartrate

2002

Completed Phase 2

~40

Adjuvant therapy

2002

Completed Phase 3

~430

Conventional surgery

2021

Completed Phase 4

~2500

Neoadjuvant Therapy

2011

Completed Phase 2

~70

3-dimensional conformal radiation therapy

2007

Completed Phase 3

~2690

Intensity-modulated radiation therapy

2006

Completed Phase 3

~1240

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,896 Total Patients Enrolled

93 Trials studying Mesothelioma

8,645 Patients Enrolled for Mesothelioma

The Cleveland ClinicLead Sponsor

1,027 Previous Clinical Trials

1,364,269 Total Patients Enrolled

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,901 Total Patients Enrolled

2 Trials studying Mesothelioma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent are patients exposed to risk when undergoing this treatment?

"The safety of this specific treatment has been judged as a 2 on our scale due to the trial's Phase 2 status. This indicates that while there is evidence supporting its security, no clinical data presently exists in relation to efficacy."

Answered by AI

Are there any opportunities to enroll in this trial as of now?

"The clinical trial data on clinicaltrials.gov indicates that, although it was first launched in August 2002 and last updated in February 2009, this particular medical study is not currently seeking participants. Nevertheless, there are 152 other trials with open enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma

2002. "Combination Chemotherapy With or Without Surgery & Chemoradiotherapy in Patients With Malignant Pleural Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00354393.