Carcinoma, Non-Small-Cell LungPhase 2NCT00379665
Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
A Phase 2 study testing Cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by Southwestern Regional Medical Center at 1 site in United States.
Trial summary
This study is being conducted in order to determine if intratumoral chemotherapy will be helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial brachytherapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Sep 2012
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with inoperable lung carcinoma and/or recurrent disease.
- Patients with symptomatic obstruction.
- Occlusion or partial occlusion of bronchi.
- Disease verified via bronchoscopy.
- Patients with a least one endobronchial tumor, measuring at least 0.5 cm.
- Patients between ages of 20 and 80 years.
- Documented informed consent must be obtained.
Who cannot join
- Patients without diagnosis confirmed by bronchoscopy.
- Patients with endobronchial tumors measuring less than 0.5 cm.
- Patients younger than 20 or older than 80 years.
- Patients who do not sign informed consent form.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Treatment Centers of America ® Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133
About this study
This study is being conducted in order to determine if intratumoral chemotherapy will be helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial brachytherapy.
Read the detailed description
Injections of cisplatin are given in conjunction with the brachytherapy procedure. If the direct intratumoral injections result in a decrease in the endobronchial obstructed airways and if the therapy is well tolerated, there will be immediate clinical benefit to this minimally invasive method, the most obvious being an improved quality of life. Approximately 2 mg cisplatin per cubic centimeter of tumor are injected into each tumor through a flexible bronchoscope. A total of four to six injections are administered one week apart. Response to therapy is assessed based on improvement in intraluminal obstruction by tumor, as assessed by endobronchial observation.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Cisplatin
- Keywords
- Lung, Chemotherapy, Cisplatin, Intratumoral, Bronchoscope, Brachytherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections.
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | Experimental | 1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections. Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened.
Measured: within 4 to 6 injections
Secondary outcomes (1)
Respiratory symptoms due to occlusion to be assessed both before and after the procedure.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2006 (estimated)
- Study startOct 2005
- Primary completionDec 2010
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southwestern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Nader, DO, Principal investigator, Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379665
- Sponsor's protocol ID
- CTCT 05-01
- Status last verified
- Dec 2012
- First submitted
- 20 Sep 2006
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
BATEMAN JC. Palliation of cancer in human patients by maintenance therapy with NN'N"-triethylene thiophosphoramide and N-(3-oxapentamethylene)-N'N"-diethylene phosphoramide. Ann N Y Acad Sci. 1958 Apr 24;68(3):1057-71. doi: 10.1111/j.1749-6632.1958.tb42664.x. No abstract available.
PubMed 13627755Burris HA 3rd, Vogel CL, Castro D, Mishra L, Schwarz M, Spencer S, Oakes DD, Korey A, Orenberg EK. Intratumoral cisplatin/epinephrine-injectable gel as a palliative treatment for accessible solid tumors: a multicenter pilot study. Otolaryngol Head Neck Surg. 1998 Apr;118(4):496-503. doi: 10.1177/019459989811800412.
PubMed 9560102Monga SP, Wadleigh R, Adib H, Harmon JW, Berlin M, Mishra L. Endoscopic treatment of gastric cancer with intratumoral cisplatin/epinephrine injectable gel: a case report. Gastrointest Endosc. 1998 Oct;48(4):415-7. doi: 10.1016/s0016-5107(98)70014-8. No abstract available.
PubMed 9786117Vogl TJ, Engelmann K, Mack MG, Straub R, Zangos S, Eichler K, Hochmuth K, Orenberg E. CT-guided intratumoural administration of cisplatin/epinephrine gel for treatment of malignant liver tumours. Br J Cancer. 2002 Feb 12;86(4):524-9. doi: 10.1038/sj.bjc.6600116.
PubMed 11870531Celikoglu F, Celikoglu SI. Intratumoural chemotherapy with 5-fluorouracil for palliation of bronchial cancer in patients with severe airway obstruction. J Pharm Pharmacol. 2003 Oct;55(10):1441-8. doi: 10.1211/0022357021936.
PubMed 14607028Celikoglu SI, Celikoglu F, Goldberg EP. Intratumoral cancer chemotherapy through a flexible bronchoscope. J Bronchol. 2004;11:260-265.
Goldberg EP, Hadba AR, Almond BA, Marotta JS. Intratumoral cancer chemotherapy and immunotherapy: opportunities for nonsystemic preoperative drug delivery. J Pharm Pharmacol. 2002 Feb;54(2):159-80. doi: 10.1211/0022357021778268.
PubMed 11848280
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratumoral Cancer Chemotherapy Through a Flexible Bronchoscope as an Adjunct to Brachytherapy
- ClinicalTrials.gov ID
- NCT00379665
- Acronym / sponsor ID
- CTCT 05-01
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Lung, Chemotherapy, Cisplatin, Intratumoral, Bronchoscope, Brachytherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Southwestern Regional Medical CenterUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Sep 2006 (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.
This study is being conducted in order to determine if intratumoral chemotherapy will be helpful in the palliation of endobronchial tumors when used in conjunction with endobronchial brachytherapy.
Detailed description
Injections of cisplatin are given in conjunction with the brachytherapy procedure. If the direct intratumoral injections result in a decrease in the endobronchial obstructed airways and if the therapy is well tolerated, there will be immediate clinical benefit to this minimally invasive method, the most obvious being an improved quality of life. Approximately 2 mg cisplatin per cubic centimeter of tumor are injected into each tumor through a flexible bronchoscope. A total of four to six injections are administered one week apart. Response to therapy is assessed based on improvement in intraluminal obstruction by tumor, as assessed by endobronchial observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | Experimental | Drug: Cisplatin1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with inoperable lung carcinoma and/or recurrent disease.
- Patients with symptomatic obstruction.
- Occlusion or partial occlusion of bronchi.
- Disease verified via bronchoscopy.
- Patients with a least one endobronchial tumor, measuring at least 0.5 cm.
Key exclusion criteria (4 listed)
- Patients without diagnosis confirmed by bronchoscopy.
- Patients with endobronchial tumors measuring less than 0.5 cm.
- Patients younger than 20 or older than 80 years.
- Patients who do not sign informed consent form.
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 |
|---|---|---|
| Cisplatin1 mg/ml at a dosage of approximately 2 mg per cubic cm of tumor. Weekly up to 6 injections. | Drug | Cisplatin |
Primary outcome
To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened.
Time frame: within 4 to 6 injections
1 secondary outcome
Respiratory symptoms due to occlusion to be assessed both before and after the procedure.
Time frame: 3 years
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 11 Dec 2012.
- Background: PubMed 13627755BATEMAN JC. Palliation of cancer in human patients by maintenance therapy with NN'N"-triethylene thiophosphoramide and N-(3-oxapentamethylene)-N'N"-diethylene phosphoramide. Ann N Y Acad Sci. 1958 Apr 24;68(3):1057-71. doi: 10.1111/j.1749-6632.1958.tb42664.x. No abstract available.
- Background: PubMed 9560102Burris HA 3rd, Vogel CL, Castro D, Mishra L, Schwarz M, Spencer S, Oakes DD, Korey A, Orenberg EK. Intratumoral cisplatin/epinephrine-injectable gel as a palliative treatment for accessible solid tumors: a multicenter pilot study. Otolaryngol Head Neck Surg. 1998 Apr;118(4):496-503. doi: 10.1177/019459989811800412.
- Background: PubMed 9786117Monga SP, Wadleigh R, Adib H, Harmon JW, Berlin M, Mishra L. Endoscopic treatment of gastric cancer with intratumoral cisplatin/epinephrine injectable gel: a case report. Gastrointest Endosc. 1998 Oct;48(4):415-7. doi: 10.1016/s0016-5107(98)70014-8. No abstract available.
- Background: PubMed 11870531Vogl TJ, Engelmann K, Mack MG, Straub R, Zangos S, Eichler K, Hochmuth K, Orenberg E. CT-guided intratumoural administration of cisplatin/epinephrine gel for treatment of malignant liver tumours. Br J Cancer. 2002 Feb 12;86(4):524-9. doi: 10.1038/sj.bjc.6600116.
- Background: PubMed 14607028Celikoglu F, Celikoglu SI. Intratumoural chemotherapy with 5-fluorouracil for palliation of bronchial cancer in patients with severe airway obstruction. J Pharm Pharmacol. 2003 Oct;55(10):1441-8. doi: 10.1211/0022357021936.
- BackgroundCelikoglu SI, Celikoglu F, Goldberg EP. Intratumoral cancer chemotherapy through a flexible bronchoscope. J Bronchol. 2004;11:260-265.
- Background: PubMed 11848280Goldberg EP, Hadba AR, Almond BA, Marotta JS. Intratumoral cancer chemotherapy and immunotherapy: opportunities for nonsystemic preoperative drug delivery. J Pharm Pharmacol. 2002 Feb;54(2):159-80. doi: 10.1211/0022357021778268.
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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.
Daniel Nader, DO principal investigator
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by Southwestern Regional Medical Center at 1 site 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?
The sponsor lists 7 inclusion and 4 exclusion criteria. 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 11 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
To affect a faster clearing of the obstruction as compared with initial evaluation, based on the percentage of lumen opened. (time frame: within 4 to 6 injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379665, which also lists 7 linked publications.
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 11 Dec 2012.