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Phase II Toxicity Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Mesothelioma

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Trial Information

Phase II Toxicity Study Using Chemotherapy +/- Pleurectomy/Decortication Followed By Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma.


Inclusion Criteria:



- Patients must have a pathologically confirmed diagnosis either at MSKCC or at the
participating site of malignant pleural mesothelioma.

- No evidence of metastatic disease.

- No prior chemotherapy for mesothelioma.

- No prior radiation therapy except for localized prostate or pelvic radiation

- Patient age ≥ or = to 18 years on day of signing informed consent.

- Karnofsky performance status ≥ or = to 70%

- Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone
according to protocol.

- Patient must have the ability to interrupt NSAIDS 2 days before (5 days for
longacting NSAIDs), the day of, and 2 days following administration of pemetrexed.

- Pulmonary Function Tests:

- FEV1 ≥ 30% of predicted postoperative (ppoFEV1) (as if the patient underwent a
pneumonectomy) based on the following formula using the quantitative V/Q scan:

- Predicted post-resection FEV1 = FEV1 x % perfusion to uninvolved lung from the
quantitative V/Q scan report.

- DLCO > 35% predicted

- Patient must have adequate organ function as indicated by the following laboratory
values:

- Hematological:

- Absolute neutrophil count ≥ or = to 1,500 /mcL

- Platelets ≥ or = to 100,000 / mcL

- Renal Calculated creatinine clearance (CrCl) ≥ or = to 45 mL/min (Creatinine
clearance must be calculated using Cockcroft & Gault method) In cases of concern
about renal toxicity from IMRT, an optional nuclear medicine kidney function scan may
be performed prior to radiation therapy to determine the functional contribution of
each kidney.

- Hepatic

- Serum total bilirubin ≤ or = to 1.5 X upper limit of normal (ULN) AST (SGOT) or ALT
(SGPT) ≤ or = to 3.0 X ULN

Exclusion Criteria:

- Pregnant or lactating women, or men or women not using effective contraception.

- Patients with resectable disease for whom extrapleural pneumonectomy is necessary.

- Patients with an active infection that require systemic antibiotics, antiviral, or
antifungal treatments.

- Patients with a concurrent active malignancy.

- Patients with serious unstable medical illness.

- Presence of third space fluid that cannot be controlled by drainage. For patients who
develop or have baseline clinically significant pleural effusions before or during
initiation of pemetrexed therapy consideration should be given to draining the
effusion prior to dosing.

- No acute congestive heart failure

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of chemotherapy +/- pleurectomy/decortication followed by IMRT to the pleura in patients with malignant pleural mesothelioma as indicated by the incidence of grade 3 or greater pneumonitis.

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Lee Krug, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-053

NCT ID:

NCT00715611

Start Date:

July 2008

Completion Date:

July 2016

Related Keywords:

  • Mesothelioma
  • pemetrexed
  • cisplatin
  • IMRT
  • PLEURA
  • Malignant
  • 08-053
  • Mesothelioma

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Memorial Sloan-Kettering at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York