ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
Malignant Mesothelioma
About this trial
This is an interventional treatment trial for Malignant Mesothelioma focused on measuring localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant pleural or peritoneal mesothelioma Measurable or evaluable disease CALGB groups 1-4 No CNS metastases PATIENT CHARACTERISTICS: Age: 21 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 3,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: SGOT no greater than 2 times upper limit of normal Bilirubin no greater than 2 mg/dL PT and PTT normal Renal: Creatinine normal Cardiovascular: No symptomatic New York Heart Association class II-IV cardiovascular disease No congestive heart failure No angina pectoris No cardiac arrhythmias No uncontrolled hypertension No cerebrovascular disease Metabolic: No serum calcium, phosphate, electrolyte, or other metabolic abnormalities, such as metabolic acidosis Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious infection No uncontrolled psychosis or neurologic disease (e.g., seizure disorders) No uncontrolled diabetes mellitus No other primary malignancy within the past 5 years except nonmelanoma skin cancer No senility or emotional instability PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than one prior systemic chemotherapy regimen No prior doxorubicin At least 6 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy Surgery: Prior surgical resection allowed
Sites / Locations
- CCOP - Northern Indiana CR Consortium
- Greenebaum Cancer Center at University of Maryland Medical Center
- Spectrum Health Hospital - Butterworth Campus
- CCOP - Duluth
- Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles
- Methodist Estabrook Cancer Center
- University of New Mexico Cancer Research and Treatment Center
- Asklepios Fachkliniken Muenchen-Gauting
- Hospital Grosshansdorf
- Asklepios Klinik St. Georg
- Asklepios Klinik Harburg
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
- Istituto Nazionale per la Ricerca sul Cancro
- Ospedale San Martino
- Fondazione I.R.C.C.S. Policlinico San Matteo
- Medical University of Gdansk
- University School of Medical Sciences
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- Klinika Chrorob Pluc I Gruzlicy
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients receive ranpirnase IV over 30 minutes weekly followed by doxorubicin IV. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression. Patients demonstrating evidence of clinical response or stable disease may continue on maintenance therapy with ranpirnase as a single agent until disease progression.
Patients receive doxorubicin as in arm I for up to 6 courses.