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Study of CBP501 + Pemetrexed + Cisplatin in Patients With Solid Tumors (Phase I) and Patients With Malignant Pleural Mesothelioma (Phase II)

Purpose: The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet combination will be assessed during the phase I part of the trial.

The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be stratified according to histology and performance status.

Arm A: Experimental. Drug: pemetrexed, cisplatin and CBP501
CBP501 for injection is provided in single dose vials (20 mg) containing a sterile lyophilized powder comprising CBP501 peptide acetate salt (peptide base units). For administration, vial contents are reconstituted in 5% Dextrose Injection, USP, and added to a 100 mL IV bag of 5% Dextrose Injection, USP.
Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.
Arm B: Active Comparator. Drug: pemetrexed and cisplatin
Pemetrexed: A commercial formulation of pemetrexed will be used, with reconstitution in 20mL 0.9% sodium chloride solution for injection, then dilution to 100mL.
Cisplatin: A commercial formulation will be used and will be diluted in 250 mL of normal saline for administration.

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Mesothelioma Avastin Plus Pemetrexed-cisplatin Study (MAPS)

Purpose: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.

Arm 1: Standard Chemotherapy
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
  • Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles)
  • Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)
Arm 2: Standard Chemotherapy + bevacizumab (Avastin)
Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
  • Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles)
  • Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles)
  • Bevacizumab 15 mg/kg D1 (D1=D22, until progression)

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N-AcetylCysteine vs. Placebo to Prevent Neurotoxicity Induced by Platinum Containing Chemotherapy (NAC-PNP)

Purpose: In this study we want to investigate the efficacy of N-acetylcysteine (NAC), which is an anti-oxidant, in the prevention of cisplatin-induced neural toxicity, in patients treated for lung cancer with chemotherapy containing cisplatin.

Arm 1: Active Comparator
  • Drug: N-Acetylcysteine.
  • Intervention:
    N-Acetylcysteine intravenously once every 3 weeks 40 mg/kg.
  • Other Name: Fluimucil
Arm 2: Placebo Comparator
  • Drug: Placebo.
  • Intervention: Placebo once every 3 weeks intravenous saline fluid.
  • Other Name: Placebo

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AZD2171 in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery

Rationale: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Purpose: This phase II trial is studying how well AZD2171 works in treating patients with malignant mesothelioma that cannot be removed by surgery.

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Suberoylanilide Hydroxamic Acid Vorinostat, MK0683 Versus Placebo in Advanced Malignant Pleural Mesothelioma

Purpose: This is a study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug, suberoylanilide hydroxamic acid, in the treatment of advanced malignant pleural mesothelioma.

Arm 1: Vorinostat
Drug: Comparator: Suberoylanilide Hydroxamic Acid (Vorinostat, MK0683)
Vorinostat 300 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity.
Arm 2: Placebo Comparator
Drug: Comparator: Placebo
Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment will continue until disease progression or unacceptable toxicity.

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Early Diagnosis of Lung Cancer and Mesothelioma in Prior Asbestos Workers

Purpose: Occupational exposure to asbestos is known increase the risk of developing cancer of the lungs (bronchogenic carcinoma) or of the pleura (mesothelioma). Symptoms are subtle and non-specific, diagnosis is often late and the prognosis consequently is dismal. Currently there is no accepted non-invasive tool for the early diagnosis of mesothelioma or lung cancer in asbestos-exposed subjects. In the last decade, low-dose computed tomography (LDCT) has been successfully developed and validated for the early diagnosis of lung cancer in high-risk smokers. Malignant mesothelioma might, in an early stage, resemble a benign pleural plaque, which is a common finding after asbestos exposure. We target to develop low-dose CT as a tool to serially image the pleural plaques, quantify their individual and overall volume, compute the growth rate with time, and, as such, identify the presence of mesothelioma early, before symptoms occur.

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Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma

Purpose: The purposes of this study are to determine:

  1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
  2. Whether Pemetrexed plus Gemcitabine can help patients with mesothelioma live longer.
  3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
  4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.

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