Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Basic Trial Information

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

Objectives

1. Compare the efficacy of doxorubicin with or without Onconase in patients with malignant pleural or peritoneal mesothelioma.
2. Compare the safety profile of these regimens in these patients.
3. 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

Expected Enrollment

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

Outcomes

Survival

Objective response
Time to best response
Response duration

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.

Trial Contact Information

Trial Lead Organizations

Alfacell Corporation

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

Registry Information
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
Trial Start Date		1997-05-15
Trial Completion Date		2008-02-15 (estimated)
Registered in ClinicalTrials.gov		NCT00003034
Date Submitted to PDQ		1997-05-20
Information Last Verified		2007-10-11