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| Sponsor: | Alfacell |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003034 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: doxorubicin hydrochloride Drug: ranpirnase |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | ONCONASE Plus Doxorubicin Versus Doxorubicin For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen |
| Estimated Enrollment: | 300 |
| Study Start Date: | May 1997 |
| Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: doxorubicin hydrochloride
Given IV
Drug: ranpirnase
Given IV
|
|
Arm II: Experimental
Patients receive doxorubicin as in arm I for up to 6 courses.
|
Drug: doxorubicin hydrochloride
Given IV
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant pleural or peritoneal mesothelioma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Metabolic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Spectrum Health Hospital - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Minnesota | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805-1983 | |
| United States, Missouri | |
| Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles | |
| St. Charles, Missouri, United States, 63301 | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | |
| Omaha, Nebraska, United States, 68114-4199 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Germany | |
| Asklepios Fachkliniken Muenchen-Gauting | |
| Gauting, Germany, D-82131 | |
| Asklepios Klinik Harburg | |
| Hamburg, Germany, D-21075 | |
| Asklepios Klinik St. Georg | |
| Hamburg, Germany, D-20099 | |
| Hospital Grosshansdorf | |
| Grosshansdorf, Germany, D-22927 | |
| Klinikum Rechts Der Isar - Technische Universitaet Muenchen | |
| Munich, Germany, D-81675 | |
| Italy | |
| Fondazione I.R.C.C.S. Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa, Italy, 16132 | |
| Ospedale San Martino | |
| Genoa, Italy, 16132 | |
| Poland | |
| Klinika Chrorob Pluc I Gruzlicy | |
| Zabrze, Poland, 41-803 | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland, 02-781 | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| University School of Medical Sciences | |
| Poznan, Poland, PL-60 569 | |
| Study Chair: | Diane Scudiery | Alfacell |
More Information
| Study ID Numbers: | CDR0000065639, ALFACELL-P30-302, NCI-V97-1273 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003034 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Ranpirnase Neoplasms, Mesothelial Antineoplastic Agents Enzyme Inhibitors Antibiotics, Antineoplastic Doxorubicin |
Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms Therapeutic Uses Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |