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

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

Basic Trial Information

Phase: Phase III
Type: Treatment
Status: Active
Age: 21 and over
Sponsor: Pharmaceutical / Industry
Protocol IDs: ALFACELL-P30-302, NCT00003034, NCI-V97-1273

Objectives

Compare the efficacy of doxorubicin with or without Onconase 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.

Entry Criteria

Disease Characteristics:

Histologically confirmed malignant pleural or peritoneal mesothelioma
- Measurable or evaluable disease
CALGB groups 1-4
No CNS metastases

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

Patient Characteristics:

Age:

21 and over

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 3,500/mm3
Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3

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

Projected Accrual

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

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 Onconase 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 Onconase 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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

Alfacell Corporation

Diane Scudiery, Protocol chair
Ph: 973-748-8082

Genoa, Italy
Istituto Nazionale per la Ricerca sul Cancro
Francesco Grossi, MD
Ph: 39-10-560-0665
Email: francesco.grossi@istge.it

Ospedale San Martino/Cliniche Universitarie Convenzionate
Ettore Cerri, MD
Ph: 39-010-555-5124

Pavia, Italy
I.R.C.C.S. Policlinico San Matteo
Albino Rossi, MD
Ph: 39-382-502-617

Ernesto Pozzi, MD
Ph: 39-0382-502-580

Sandpierdarena, Italy
Az. Ospedale Villa Scassi
Bruno Faravelli, MD
Ph: 39-010-410-231-8295

Venice, Italy
Ospedale Civile San Giovanni e Paolo
Adriano Paccagnella, MD
Ph: 39-041-529-4531
Email: adriano.paccagnella@ulss12.ve.it

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