Phase II Clinical Study of a Liposome Entrapped Cisplatin Analog (L-NDDP) Administered Intrapleurally in Patients With Malignant Pleural Mesothelioma

Inclusion Criteria

DISEASE CHARACTERISTICS: Pathologically confirmed malignant pleural mesothelioma Free
flowing pleural effusion

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
At least 12 weeks Hematopoietic: WBC greater than 4,000/mm3 Granulocyte count greater than
1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
mg/dL SGPT no greater than 1.5 times upper limit of normal Renal: Creatinine no greater
than 1.5 mg/dL Cardiovascular: No unstable angina No clinical evidence of congestive heart
failure Pulmonary: No postobstructive pneumonia Other: Fertile patients must use effective
contraception Not pregnant or nursing No serious concurrent infection No prior
malignancies except basal cell or squamous cell skin carcinomas, stage I colon, cervical,
breast, prostate, head and neck, or lung cancer, as long as there has been no evidence of
tumor occurrence within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
No concurrent immunotherapy Chemotherapy: No prior chemotherapy No concurrent chemotherapy
Endocrine therapy: At least 3 weeks since prior hormonal therapy No concurrent hormonal
therapy Radiotherapy: No prior chest radiotherapy At least 3 weeks since other prior
radiotherapy No concurrent radiotherapy Surgery: Prior pleurodesis or chest surgery on the
same side of the effusion is allowed as long as there is a free flowing pleural effusion
without loculation At least 2 weeks since major surgery other than biopsy Other: At least
3 weeks since use of any other investigational medication No concurrent use of any other
investigational medications