Mesothelioma
(Clinical Trials)

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Onconase vs. Doxorubicin

Title: Phase III Multicenter Study comparing Onconase and Doxorubicin.

Eligibility Requirements:
Measurable or evaluable disease.
May have received one prior chemotherapy regimen that did not include Doxorubicin.

Patients will be randomized to receive either Doxorubicin or Onconase intravenous in the outpatient setting.

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Trimodal Therapy

Title: Phase II Trial of Combined Resection, Intraperitoneal Chemotherapy and Whole Abdominal Radiation for Treatment of Peritoneal Mesothelioma.

Eligibility Requirements:
Measurable or evaluable disease.
0-1 prior chemotherapy regimens allowed.
Prior surgical resection is permitted.

Patients will undergo exploratory laparotomy with a total omentectomy and total excision of all visible peritoneal, retroperitoneal and pelvic disease. Patients will then be treated with intraperitoneal chemotherapy over a three to six month period followed by second look surgery. At the time of the second surgery patients will receive intraoperative heat treated chemotherapy. Radiation therapy will follow the second look surgery.

 

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Gene Therapy (p53)

Title: Phase II Gene Therapy Study in Patients with Malignant Pleural or Peritoneal Mesothelioma using rAd/p53 in Combination with Chemotherapy.

Trial is currently under development and projected to open shortly.

Eligibility Requirements:
Patients with peritoneal or pleural mesothelioma
Prior chemotherapy/prior surgery permitted.
Evidence of p53 gene mutation will be assessed

Patients will be treated for three cycles with multiple intrapleural or intraperitoneal injections of rAd/p53 in combination with intravenous cisplatin. These treatments will take place at twenty-eight day intevals.

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Gemcitabine and Cisplatin Regimen

Title: Phase II Study in Collaboration with the Southwest Oncology Group of Gemcitabine and Cisplatin for the treatment of Pleural Mesothelioma.

Eligibility Requirements:
Unresectable malignant mesothelioma of the pleura.
No prior chemotherapy .
No prior radiation therapy

Patients will be treated on an outpatient basis with both intravenous Gemcitabine and Cisplatin.

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Gemcitabine and Taxol Regimen

Title: Phase II single institution study of Gemcitabine and Taxol for the treatment of Malignant Mesothelioma.

Trial is under development at the present time.

Eligibility Requirements:
Nonresectable malignant mesothelioma either of the pleura or peritoneum.
Prior chemotherapy is permitted.

Patients will be treated with both Taxol and Gemcitabine intravenously.