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Malignant Pleural MesotheliomaPhase 1NCT02639767

Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma

A Phase 1 study testing Pemetrexed/Cisplatin, Pleural Intensity Modulated Radiation Therapy and MRI in people with Malignant Pleural Mesothelioma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the safety of combining chemotherapy at different doses with a specific type of radiation therapy delivered to the entire lining of the lung to find out what effects, if any, it has on people. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Pleural Mesothelioma
What is being tested?
Pemetrexed/Cisplatin, Pleural Intensity Modulated Radiation Therapy and MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
6 sitesUnited States
Study dates
Dec 2015to Dec 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed diagnosis of malignant pleural mesothelioma at MSKCC
  • No plans for surgical resection
  • Stage T1-4, N0-3, M0
  • No prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose
  • Prior chemotherapy regimens ≤1
  • Age ≥18 years
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  • Karnofsky performance status ≥ 80%
  • Pulmonary function tests as follows: DLCO>50% predicted
  • Adequate hematologic, hepatic, and renal function as indicated by the following laboratory values
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL
  • Calculated creatinine clearance (CrCl) ≥ 45mL/min (using Cockcroft \& Gault method)
  • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless known Gilbert's disease)
  • AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN

Who cannot join

  • Pregnant or lactating women, or men or women not using effective contraception
  • Patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments
  • Patients with a concurrent active malignancy (with the exception of skin cancer)
  • Patients with serious unstable medical illness
  • Patients with idiopathic pulmonary fibrosis
  • Patients with NYHA heart failure class >2
Show all 12Show fewer
  • Patients with only one kidney that is ipsilateral to the mesothelioma
  • Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be moved
  • Patients meeting the following exclusion criteria will be excluded from the MRI portion only:
  • Metallic implant, e.g. pacemaker, defibrillator
  • Unmanageable claustrophobia
  • High risk for nephrogenic systemic fibrosis

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Memorial Sloan Kettering at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering West Harrison

    East White Plains, New York, 10604

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York

  • Memoral Sloan Kettering Cancer Center at Phelps

    Sleepy Hollow, New York, 10591

Other trials in United States

About this study

Official title: A Phase I Study of Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma

The purpose of this study is to evaluate the safety of combining chemotherapy at different doses with a specific type of radiation therapy delivered to the entire lining of the lung to find out what effects, if any, it has on people. This radiation technique is called pleural intensity modulated radiation therapy (IMRT). IMRT specifically targets the lining of the lung (pleura) where the cancer is and reduces the risk of damaging the lung itself. When given after chemotherapy, pleural IMRT has demonstrated promising results with respect to keeping mesothelioma under control longer. However, the investigators want to determine if giving pleural IMRT at the same time as chemotherapy is safe. If safe, further studies will be done to see if chemotherapy and pleural IMRT given at the same time keeps the tumor under control for a longer period of time than chemotherapy followed by pleural IMRT.

Being tested
Pemetrexed/Cisplatin, Pleural Intensity Modulated Radiation Therapy, MRI
Keywords
Pemetrexed, Cisplatin, Intensity Modulated Radiation Therapy, 15-304
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pemetrexed/CisplatinDrug

    Dose escalation of pemetrexed and cisplatin will follow the dose levels. The escalation will not exceed 500 mg/m^2 for pemetrexed in combination with 75 mg/m^2 of cisplatin even if the maximum tolerated dose is not identified. Each treatment cycle of chemotherapy will be 21 days. Patients will receive up to 2 cycles of chemotherapy during the radiation, and be followed for any DLT during the radiation therapy and for 12 weeks afterwards.

  • Pleural Intensity Modulated Radiation TherapyRadiation

    Pleura intensity modulated radiation therapy (IMRT) will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions. The prescription radiation dose may anywhere between 45 and 50.4 Gy in 25 fractions if necessary to meet the normal tissue dose constraints.

  • MRIDevice

    A pre-treatment MRI before chemo-RT will be acquired and will be used for target delineation. A three month post-treatment MRI will be acquired with the same protocol to assess the response from concurrent chemo-RT.

Study groups in NCT02639767
Study groupRoleWhat they receive
pemetrexed/cisplatin with pleural IMRTExperimentalThis is a single institution phase I study of pemetrexed/cisplatin given concurrently with pleural intensity modulated radiation therapy (IMRT) in patients with unresectable malignant pleural mesothelioma (MPM). All patients will receive pleural intensity modulated radiation therapy (IMRT). Patients will be enrolled in cohorts of 3-6 at each dose level of pemetrexed/cisplatin, and dose escalation will proceed in a standard 3+3 fashion until the maximum tolerated dose (MTD) is identified.
Receives: Drug: Pemetrexed/Cisplatin; Radiation: Pleural Intensity Modulated Radiation Therapy; Device: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities (DLT)

    The NCI Common Terminology Criteria for Adverse Events version 4.0 will be used to grade toxicities during the trial. DLTs are defined as any of the following events occurring during and for the first 12 weeks after completing pleural IMRT

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2016

Why it stopped: Lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02639767
Sponsor's protocol ID
15-304
Status last verified
Dec 2016
First submitted
18 Dec 2015
Last updated
7 Dec 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pemetrexed/Cisplatin, Pleural Intensity Modulated Radiation Therapy and MRI in people with Malignant Pleural Mesothelioma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicities (DLT) (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02639767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.

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