Brief Title
Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma
Official Title
Phase II Clinical Study of a Liposome Entrapped Cisplatin Analog (L-NDDP) Administered Intrapleurally in Patients With Malignant Pleural Mesothelioma
Brief Summary
RATIONALE: Patient abstract not available
PURPOSE: Patient abstract not available
Detailed Description
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 years.
Study Phase
Phase 2
Study Type
Interventional
Condition
Malignant Mesothelioma
Intervention
liposomal NDDP
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
September 1998
Primary Completion Date
May 2001
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Abraham Chachoua, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00004033
Organization ID
CDR0000066141
Secondary IDs
P30CA016087
Study Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Abraham Chachoua, MD, Study Chair, NYU Langone Health
Verification Date
March 2011