Onconase plus Doxorubicin vs. Doxorubicin
Title: Multicenter randomized comparative phase III trial of onconase plus doxorubicin vs. doxorubicin in patients with malignant mesothelioma (part II)
Eligibility Requirements:
Histologically verified diagnosis of malignant mesothelioma
Pathology slides must be available for independent review
Patients aged 21 years or older
Chemotherapy naive or 1 prior chemo (excluding doxorubicin)
Treatment Plan:
Randomized to either Onconase plus doxorubicin or doxorubicin alone
Group I: Onconase will be given as a bolus intravenous infusion over 30 minutes weekly
followed by a bolus intravenous infusion of doxorubicin every 3 weeks
Group II: Doxorubicin will be given as a bolus intravenous infusion every 3 weeks
Trimodal Therapy
Title: Phase II trial of combined resection, intraperitoneal chemotherapy,
and whole abdominal radiation in peritoneal mesothelioma
Eligibility Requirements:
Histologically confirmed malignant peritoneal mesothelioma
0-2 prior chemotherapy regimens allowed
At least 6 weeks since chemotherapy
No prior radiation to abdomen or lower chest
Treatment Plan:
Exploratory laparotomy will be done to try to remove all lesions > 1cm.
Three to 4 weeks later, doxorubicin, alternating with cisplatin and gemcitabine,
will be administered intraperitoneally for approximately 12 weeks. Gamma-interferon
will be given weekly for the last 4 weeks of chemotherapy. After a second-
look surgery, patients will commence radiotherapy, which will last 5-7 weeks
Perioperative Gemcitabine
and Cisplatin
Title: Phase II trial of perioperative gemcitabine and cisplatin
chemotherapy in resected pleural mesothelioma
Eligibility Requirements:
Histologically confirmed malignant pleural mesothelioma
No prior chemotherapeutic regimens
Treatment Plan:
For patients referred prior to surgery: Chemotherapy will be given for 6 weeks followed
by surgical removal of disease-affected lung tissue. This will be followed by another
6 weeks of chemotherapy, radiation therapy and another 6 weeks of chemotherapy.
For patients referred after surgery: Surgical removal of disease-affected lung tissue
will be followed by 9 weeks of chemotherapy. This will be followed by radation therapy
and another 9 weeks of chemotherapy.
ALIMTA and Cisplatin
Title: Open-Label Study of ALIMTA (pemetrexed) in Combination with Cisplatin for Chemonaive Patients with Malignant Pleural Mesothelioma
Eligibility Requirements:
Histologically confirmed malignant pleural mesothelioma
No prior chemotherapeutic regimens
Prior radiation more than 2 weeks
Treatment Plan:
ALIMTA will be given as a 10-minute intravenous infusion on day 1 of a 21-day cycle. Cisplatin will be given as a 2-hour intravenous infusion on day 1 of a 21-day cycle.
ALIMTA and Gemcitabine
Title: ALIMTA plus Gemcitabine as Front-Line Chemotherapy for Patients with Malignant Pleural or Peritoneal Mesothelioma. A Phase II Clinical Trial
Eligibility Requirements:
Histologically confirmed malignant pleural or peritoneal mesothelioma
No prior chemotherapeutic regimens
Prior radiation allowed (more than 4 weeks)
Prior surgery allowed (more than 4 weeks)
Treatment Plan:
Folic acid and vitamin B 12 supplements will be given 1-2 weeks prior to chemotherapy administration. Gemcitabine will be given intravenously over 30 minutes on days 1 and 8 of a 21-day cycle. ALIMTA will be given intravenously over 10 minutes on day 8 (prior to gemcitabine) of a 21-day cycle.
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