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



    - General Info     - Purpose     - Eligibility     - Contacts & Locations     - Additional Information


Status: Active
Sponsors and Collaborators: New York University School of Medicine; National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00004033

Condition: Malignant Mesothelioma
Intervention: Drug: liposomal-NDDP; Procedure: chemotherapy; Procedure: thoracoscopic surgery


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Purpose:


RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Clinical Study of a Liposome Entrapped Cisplatin Analog (L-NDDP) Administered Intrapleurally in Patients With Malignant Pleural Mesothelioma

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: September 1998

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.


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Eligibility:

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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


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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004033
Locations
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center    
      New York, New York, United States, 10016
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030-4009

Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)

Investigators
Study Chair:     Abraham Chachoua, MD     New York University School of Medicine    

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Additional Information:

Study ID Numbers: CDR0000066141, NYU-9850, MDA-FDR001234, MDA-ID-95209, NCI-G99-1575
First Received: December 10, 1999
Last Updated: October 25, 2007
ClinicalTrials.gov Identifier: NCT00004033
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Study placed in the following topic categories:
Cisplatin
Mesothelioma
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Mesothelioma
Neoplasms, Mesothelial

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