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| ID | Type | Description | Link |
|---|---|---|---|
| ALFACELL-P30-302 | |||
| NCI-V97-1273 |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin is more effective than doxorubicin alone in treating patients with malignant mesothelioma.
PURPOSE: This randomized phase III trial is studying doxorubicin alone to see how well it works compared to doxorubicin and Onconase in treating patients with malignant mesothelioma.
OBJECTIVES:
OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to disease histology (epithelioid vs nonepithelioid) and CALGB groups 1-4. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | 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. |
|
| Arm II | Experimental | Patients receive doxorubicin as in arm I for up to 6 courses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxorubicin hydrochloride | Drug | Given IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Survival |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response | ||
| Time to best response | ||
| Response duration |
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DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural or peritoneal mesothelioma
CALGB groups 1-4
No CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Metabolic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Diane Scudiery | Alfacell | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States | ||
| Greenebaum Cancer Center at University of Maryland Medical Center |
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| ranpirnase |
| Drug |
Given IV |
|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Spectrum Health Hospital - Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805-1983 | United States |
| Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles | Saint Charles | Missouri | 63301 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114-4199 | United States |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Asklepios Fachkliniken Muenchen-Gauting | Gauting | D-82131 | Germany |
| Hospital Grosshansdorf | Großhansdorf | D-22927 | Germany |
| Asklepios Klinik St. Georg | Hamburg | D-20099 | Germany |
| Asklepios Klinik Harburg | Hamburg | D-21075 | Germany |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Munich | D-81675 | Germany |
| Istituto Nazionale per la Ricerca sul Cancro | Genoa | 16132 | Italy |
| Ospedale San Martino | Genoa | 16132 | Italy |
| Fondazione I.R.C.C.S. Policlinico San Matteo | Pavia | 27100 | Italy |
| Medical University of Gdansk | Gdansk | 80-211 | Poland |
| University School of Medical Sciences | Poznan | PL-60 569 | Poland |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | 02-781 | Poland |
| Klinika Chrorob Pluc I Gruzlicy | Zabrze | 41-803 | Poland |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| C058703 | ranpirnase |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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