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

Phase 2
18 Years
Not Enrolling
Malignant Mesothelioma

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Trial Information

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

OBJECTIVES: I. Determine the antitumor efficacy of a liposomal-cisplatin analogue (L-NDDP)
administered into the pleural space in patients with malignant pleural mesothelioma. II.
Determine the time to progression and overall survival in this patient population. III.
Evaluate the quantitative and qualitative toxicity of intrapleural L-NDDP.

OUTLINE: All patients undergo a thoracoscopy under general anesthesia. The thoracoscope is
removed and any collected fluid is drained from the chest cavity. The first treatment with
liposomal-cisplatin analogue (L-NDDP) is administered at this time into the intrapleural
space over a 10 minute period. Subsequent 10 minute intrapleural infusions of L-NDDP through
a percutaneous catheter are administered every 3 weeks. Treatment continues unless
unacceptable toxic effects or disease progression occurs. Antitumor activity is assessed 2
months after the second course of therapy, and every 2 months thereafter.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2.5

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Abraham Chachoua, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

Related Keywords:

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



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016