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Mesothelioma
Clinical Trials (Updated 28-Feb-03)



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.