Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00004033
First received: December 10, 1999
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available


Condition Intervention Phase
Malignant Mesothelioma
Drug: liposomal NDDP
Procedure: therapeutic thoracoscopy
Phase 2

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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Estimated Enrollment: 30
Study Start Date: September 1998
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
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.

  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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004033     History of Changes
Other Study ID Numbers: CDR0000066141, P30CA016087, NYU-9850, MDA-FDR001234, MDA-ID-95209, NCI-G99-1575
Study First Received: December 10, 1999
Last Updated: March 25, 2011
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Lung Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014