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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 21 and over Other TCSC-P-30-P/PHII NCI-V92-0008

Objectives

I.  Determine the efficacy of single repetitive weekly intravenous doses of 
P-30 protein in patients with advanced malignant mesothelioma.

II.  Assess the clinical toxicity of P-30 protein in this patient population.

Entry Criteria

Disease Characteristics:

Pathologically proven, advanced malignant mesothelioma that is previously
untreated or has failed 1 prior conventional therapeutic regimen

Bidimensionally measurable disease required
  Elevated tumor markers are not allowed as sole indicators of measurable
  disease

No previously established brain metastases or leptomeningeal disease (unless
no other therapeutic option is available)

Prior/Concurrent Therapy:

Biologic therapy:
  No prior interferons, interleukin-2 (or other interleukins), tumor necrosis
  factor, or other biological response modifiers

Chemotherapy:
  No more than 1 prior conventional chemotherapy regimen
  At least 4 weeks since chemotherapy (at least 6 weeks since nitrosoureas and
     mitomycin)
  Recovery from toxicity of prior chemotherapy to grade 0 or 1 required

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since radiotherapy
  Recovery from toxicity of prior radiotherapy to grade 0 or 1 required

Surgery:
  At least 4 weeks since surgery
  Recovery from toxicity of prior surgery to grade 0 or 1 required

Other:
  No prior organ allograft
  No requirement for systemic corticosteroids

Patient Characteristics:

Age:
  21 and over

Performance status:
  ECOG 0 or 1 (Karnofsky 80%-100%)

Life expectancy:
  At least 3 months

Hematopoietic:
  WBC at least 3,000
  AGC at least 1,500
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 2 times normal
  AST no greater than 2 times normal
  No bleeding disorder or coagulation abnormality

Renal:
  Creatinine normal
  Creatinine clearance greater than 50 mL/min
  24-hour proteinuria no greater than 2 g

Metabolic:
  Calcium normal
  Phosphate normal
  Electrolytes normal
  No metabolic acidosis or other metabolic abnormality

Cardiovascular:
  No NYHA class II-IV status
  No congestive heart failure
  No angina
  No arrhythmia
  No uncontrolled hypertension

Other:
  No active severe infection
  No uncontrollable diabetes mellitus
  HBsAg seronegative
  No severe anorexia
  No grade 3/4 nausea or vomiting
  No psychiatric disorders (unless no other therapeutic option is available)
  No neurologic disorder including seizures (unless no other therapeutic
     option is available)
  No pregnant or nursing women
  Effective contraception required of fertile women

Expected Enrollment

At least 20 patients will be entered.

Outline

Single-Agent Chemotherapy.  P-30 Protein.

Trial Contact Information

Trial Lead Organizations

Thompson Cancer Survival Center

Samuel McCachren, MD, Protocol chair		Ph: 865-541-1720