Malignant MesotheliomaPhase 2NCT00004033
Liposomal-Cisplatin Analogue (L-NDDP) in Treating Patients With Malignant Pleural Mesothelioma
A Phase 2 study testing liposomal NDDP and therapeutic thoracoscopy in people with Malignant Mesothelioma, run by NYU Langone Health at 2 sites in United States.
Trial summary
RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Mesothelioma
- What is being tested?
- liposomal NDDP and therapeutic thoracoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1998to May 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
About this study
Official title: Phase II Clinical Study of a Liposome Entrapped Cisplatin Analog (L-NDDP) Administered Intrapleurally in Patients With Malignant Pleural Mesothelioma
RATIONALE: Patient abstract not available
PURPOSE: Patient abstract not available
Read the 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.
- Conditions
- Malignant Mesothelioma
- Being tested
- liposomal NDDP, therapeutic thoracoscopy
- Keywords
- localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal NDDPDrug
therapeutic thoracoscopyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2004 (estimated)
- Study startSep 1998
- Primary completionMay 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Abraham Chachoua, MD, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004033
- Sponsor's protocol ID
- CDR0000066141
- Other IDs
- P30CA016087, NYU-9850, MDA-FDR001234, MDA-ID-95209, NCI-G99-1575
- Status last verified
- Mar 2011
- First submitted
- 10 Dec 1999
- Last updated
- 28 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of a Liposome Entrapped Cisplatin Analog (L-NDDP) Administered Intrapleurally in Patients With Malignant Pleural Mesothelioma
- ClinicalTrials.gov ID
- NCT00004033
- Acronym / sponsor ID
- CDR0000066141
- Conditions
- Malignant Mesothelioma
- Keywords
- localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1998
- Primary completion
- May 2001 (actual)
- First posted
- 15 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal NDDP | Drug | – |
| therapeutic thoracoscopy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Chachoua, MD study chair
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liposomal NDDP and therapeutic thoracoscopy in people with Malignant Mesothelioma, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2011.