Know Cancer

forgot password

Phase II Study on Tomusex in Malignant Mesothelioma

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

Thank you

Trial Information

Phase II Study on Tomusex in Malignant Mesothelioma

OBJECTIVES: I. Determine the therapeutic activity and toxicities of raltitrexed in patients
with inoperable malignant mesothelioma. II. Determine the objective response rate and
duration of response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Within 2 weeks of staging procedures, patients receive
raltitrexed IV over 15 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 8
courses in the absence of disease progression or unacceptable toxicity. Patients are
followed every 6 weeks until disease progression and then every 8 weeks thereafter for

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven inoperable malignant mesothelioma All tumor
stages eligible At least 1 target lesion with measurable disease in at least 1 dimension
(20 cm or more with conventional techniques OR 10 cm or more with spiral CT scans) Outside
irradiated field Prior surgery allowed if evidence of disease progression thereafter No
signs or symptoms of CNS metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ZUBROD/ECOG/WHO 0-2 (after
palliative measures such as pleural drainage) Life expectancy: Not specified
Hematopoietic: Hemoglobin at least 10.0 g/dL WBC at least 4,000/mm3 Absolute neutrophil
count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than
1.46 mg/dL Albumin at least 3.0 g/dL ALT and AST less than 2.5 times upper limit of normal
(ULN) (less than 5 times ULN if liver involvement) Renal: Creatinine less than 1.69 mg/dL
Creatinine clearance at least 65 mL/min Other: No other malignancies (including melanoma,
hypernephroma, or breast carcinoma) within the past 5 years except basal cell or squamous
cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile
patients must use effective contraception No uncontrolled infection No psychologic,
familial, sociologic, or geographic condition that could interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer immunotherapy before
first disease progression Chemotherapy: No prior systemic or intracavitary cytotoxic drugs
No concurrent intrapleural or other systemic cytotoxic drugs Endocrine therapy: No
concurrent anticancer hormonal agents (except corticosteroids) before first disease
progression Radiotherapy: See Disease Characteristics Concurrent palliative radiotherapy
allowed for painful lesions, needle tracts, or surgical scars or prevention of metastases
along biopsy tracks At least 4 weeks since prior radiotherapy No prior radiotherapy to
sole indicator lesion unless lesion is clearly progressive Surgery: See Disease
Characteristics Prior pleurodesis allowed except with cytotoxic drugs (e.g., bleomycin)
Concurrent pleurodesis with noncytotoxic drugs allowed Other: At least 1 month since other
prior investigational agent No other concurrent anticancer agents before first disease

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Giuseppe Giaccone, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Free University Medical Center


United States: Federal Government

Study ID:




Start Date:

November 1999

Completion Date:

Related Keywords:

  • Malignant Mesothelioma
  • localized malignant mesothelioma
  • advanced malignant mesothelioma
  • recurrent malignant mesothelioma
  • Mesothelioma