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Malignant MesotheliomaPhase 3NCT00003034

ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen

A Phase 3 study testing doxorubicin hydrochloride and ranpirnase in people with Malignant Mesothelioma, run by Alfacell at 19 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Malignant Mesothelioma
What is being tested?
doxorubicin hydrochloride and ranpirnase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
19 sitesin 4 countries
Study dates
May 1997to Feb 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

19 sites in 4 countries.

19 sites in 4 countries

United States7 sites

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • CCOP - Duluth

    Duluth, Minnesota, 55805-1983

  • Spectrum Health Hospital - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114-4199

  • Missouri Cancer Care, PC at St. Joseph Health Center - St. Charles

    Saint Charles, Missouri, 63301

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

Other trials in United States

Germany5 sites

  • Asklepios Fachkliniken Muenchen-Gauting

    Gauting, D-82131

  • Hospital Grosshansdorf

    Großhansdorf, D-22927

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • Asklepios Klinik Harburg

    Hamburg, D-21075

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

Other trials in Germany

Poland4 sites

  • Medical University of Gdansk

    Gdansk, 80-211

  • University School of Medical Sciences

    Poznan, PL-60 569

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02-781

  • Klinika Chrorob Pluc I Gruzlicy

    Zabrze, 41-803

Other trials in Poland

Italy3 sites

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa, 16132

  • Ospedale San Martino

    Genoa, 16132

  • Fondazione I.R.C.C.S. Policlinico San Matteo

    Pavia, 27100

Other trials in Italy

About this study

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

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.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of doxorubicin with or without ranpirnase in patients with malignant pleural or peritoneal mesothelioma.
  • Compare the safety profile of these regimens in these patients.
  • Compare the overall survival, progression-free survival, and quality of life of patients treated with these regimens.

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.

  • Arm I: 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: Patients receive doxorubicin as in arm I for up to 6 courses. Quality of life is assessed.

PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.

Being tested
doxorubicin hydrochloride, ranpirnase
Keywords
localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00003034
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: doxorubicin hydrochloride; Drug: ranpirnase
Arm IIExperimentalPatients receive doxorubicin as in arm I for up to 6 courses.
Receives: Drug: doxorubicin hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

Secondary outcomes (3)

  1. Objective response

  2. Time to best response

  3. Response duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 1997
  3. Primary completionFeb 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003034
Sponsor's protocol ID
CDR0000065639
Other IDs
ALFACELL-P30-302, NCI-V97-1273
Status last verified
Oct 2007
First submitted
1 Nov 1999
Last updated
6 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing doxorubicin hydrochloride and ranpirnase in people with Malignant Mesothelioma, run by Alfacell at 19 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Germany, Poland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.

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