Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004033
Other study ID # CDR0000066141
Secondary ID P30CA016087NYU-9
Status Completed
Phase Phase 2
First received December 10, 1999
Last updated March 25, 2011
Start date September 1998

Study information

Verified date March 2011
Source New York University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date
Est. primary completion date May 2001
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
liposomal NDDP

Procedure:
therapeutic thoracoscopy


Locations

Country Name City State
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States NYU School of Medicine's Kaplan Comprehensive Cancer Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York University School of Medicine National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Recruiting NCT06057935 - A Study of Additional Chemotherapy After Surgery for People With Malignant Peritoneal Mesothelioma Phase 2
Completed NCT00821860 - Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma Phase 3
Completed NCT00075699 - Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma Phase 3
Active, not recruiting NCT03678350 - Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery Phase 1
Recruiting NCT02580747 - Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso Phase 1
Completed NCT00398138 - Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma Phase 1
Completed NCT00019825 - Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura Phase 1
Terminated NCT00898547 - Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107
Active, not recruiting NCT00030459 - Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma Phase 2
Completed NCT00004183 - Capecitabine in Treating Patients With Malignant Mesothelioma Phase 2
Completed NCT00005636 - Cisplatin With or Without Pemetrexed Disodium in Treating Patients With Malignant Mesothelioma of the Pleura That Cannot be Removed by Surgery Phase 3
Completed NCT00004254 - Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed Phase 2
Completed NCT00004920 - Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura Phase 3
Completed NCT00334594 - Pemetrexed Disodium and Cisplatin Followed by Surgery With or Without Radiation Therapy in Treating Patients With Malignant Pleural Mesothelioma Phase 2
Completed NCT01291420 - Dendritic Cell Vaccination for Patients With Solid Tumors Phase 1/Phase 2
Recruiting NCT03852823 - Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours Phase 1
Active, not recruiting NCT01649024 - A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma Phase 2
Completed NCT00513877 - Bortezomib in Treating Patients With Malignant Pleural Mesothelioma Phase 2
Completed NCT00372840 - Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer N/A
Active, not recruiting NCT00253409 - Combination Chemotherapy With or Without Surgery and Radiation Therapy in Treating Patients With Mesothelioma That Can Be Removed By Surgery N/A