Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

liposomal NDDP

+ therapeutic thoracoscopy

DrugProcedure
Who is being recruted

Adenoma+11

+ Lung Diseases

+ Lung Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1998
See protocol details

Summary

Principal SponsorNYU Langone Health
Last updated: March 28, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00004033
Principal SponsorNYU Langone Health
Last updated: March 28, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenomaLung DiseasesLung NeoplasmsMesotheliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialPleural NeoplasmsRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms, MesothelialMesothelioma, Malignant

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, United StatesOpen NYU School of Medicine's Kaplan Comprehensive Cancer Center in Google Maps

University of Texas - MD Anderson Cancer Center

Houston, United States
Completed2 Study Centers