Lung CancerPhase 1NCT00059605
Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
A Phase 1 study testing DOTAP:Chol-fus1 in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out the highest safe dose of DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- DOTAP:Chol-fus1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Apr 2011
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically or cytologically documented non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
- For NSCLC subjects: Locally advanced, unresectable, incurable stage IIIB (pleural effusion) or stage IV NSCLC, or recurrent NSCLC that is not potentially curable by radiotherapy or surgery. Patients must have received at least one prior platinum-based chemotherapy regimen for NSCLC. For SCLC subjects: Extensive disease or recurrent disease after initial treatment for limited disease. Patients must have received prior platinum-based chemotherapy or chemoradiotherapy. All subjects: There is no limit to the number of prior chemotherapy regimens received.
- Preference will be given to patients with tumors amenable to biopsy. In the expansion cohort at MTD, all patients must have tumor amenable to biopsy and must consent to biopsy.
- Karnofsky Performance Status >= 70%, or Zubrod Performance Status <= 1.
- Negative serum pregnancy test (serum HCG) if female and of childbearing potential. Since beta-HCG may be falsely elevated as a result of malignancy, women of child-bearing potential who have an elevated serum beta-HCG level are eligible for enrollment if they have two Transvaginal Ultrasound (TVUS) scans one week apart and serial beta-HCG levels two weeks apart that are inconsistent with pregnancy and a Gynecology consult to ensure that the beta- HCG level was at a value high enough to see pregnancy with TVUS. Subjects must agree to practice effective birth control during the study period.
- Negative serology for Human Immunodeficiency Virus.
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- Patients must be >/= 4 weeks beyond major surgical procedures such as thoracotomy, laparotomy or joint replacement, and must be >/= 1.5 weeks beyond minor surgical procedures such as biopsy of subcutaneous tumors, pleuroscopy, etc, and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery. Absolute neutrophil count (ANC) > 1500 * 109/mm3, platelet count > 100,000 * 109/mm3. Prothrombin time (PT) and Partial thromboplastin time (PTT) < 1.25 times the institutional upper limit of normal.
- Adequate renal function documented by serum creatinine of <= 1.5 mg/dl or calculated creatinine clearance > 50 ml/min.
- Adequate hepatic function as documented by serum bilirubin< 1.5 mg/dl and SGOT and SGPT </= 1.5 * upper limit of normal.
- FEV1 and corrected DLCO of >/= 40% of predicted.
- Patients with asymptomatic brain metastases that have been treated are eligible if the following criteria are met: No history of seizures in the preceding 6 months. Definitive treatment must have been completed ≥4weeks prior to registration. Subjects must be off steroids that were being administered because of brain metastases or related symptoms for ≥2 weeks. Post-treatment imaging within 2 weeks of registration must demonstrate stability or regression of the brain metastases.
- Stable cardiac condition with a left ventricular ejection fraction > 50%.
- Patients must have voluntarily signed an informed consent in accordance with institutional policies.
Who cannot join
- Females who are pregnant or breast-feeding.
- Patients who received investigational therapy, monoclonal antibody such as bevacizumab or cetuximab, or who received radiotherapy to the skull, spine, thorax or pelvis within 30 days of entry into the protocol. Patients are permitted to have received palliative radiotherapy to an extremity provided at least 14 days has elapsed since completion of therapy, provided the patient received no more than 10 radiotherapy fractions and a dose no higher than 30 Gy to that site, and provided skull, spine, thorax or pelvis were not in the radiotherapy field.
- Patients with brain metastases (except as allowed in inclusion criterion #11). Neurological assessment will be used to determine brain metastases.
- Active systemic viral, bacterial or fungal infections requiring treatment.
- Patients with serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the investigator, would not permit adequate follow-up and compliance with the study protocol.
- Use of any investigational agent within four weeks of study treatment.
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- Prior gene therapy.
- History of myocardial infarction within 6 months, angina within the past 6 months, or a history of arrhythmias on active therapy.
- Patients who have received standard chemotherapy with FDA approved agents within 21 days of entry into the protocol.
- Patients who have received therapy with an oral tyrosine kinase inhibitor (eg, erlotinib) within 14 days prior to entry into the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Study Of Intravenous DOTAP:Cholesterol-Fus1 Liposome Complex (DOTAP:Chol-fus1) In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy
The goal of this clinical research study is to find out the highest safe dose of DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene (fus1) into cancer cells, using the drug DOTAP:Cholesterol-fus1. Researchers will also study the side effects of this experimental gene transfer at different doses, and will conduct tests to see if there are any effects on tumor size at different doses. Experimental transfer of the fus1 gene into humans has never been tried before.
Objectives:
- Assess the toxicity of DOTAP:Cholesterol-fus1 Liposome Complex (DOTAP:Chol-fus1) administered intravenously.
- To determine the maximal tolerated dose and recommended phase II dose of DOTAP:Chol-fus1 administered intravenously.
- Assess the expression of fus1 following intravenous delivery of DOTAP:Chol-fus1 in tumor and normal bronchial epithelial cell biopsies.
- Assess any anti-cancer activity for DOTAP:Chol-fus1.
Read the detailed description
DOTAP:Chol-fus1 is a drug that helps transfer the fus1 gene into cancer cells. It is thought that the absence of the fus1 gene may be involved in the development of lung cancer tumors. The idea is to try to replace this gene in lung cancer cells.
Participants in this study must have advanced lung cancer that has worsened after receiving prior chemotherapy. Before treatment begins, participants will have a physical exam. Blood (about 2 tablespoons) and urine tests will be performed. Women able to have children will have a blood pregnancy test. Please note that it is possible that the tumor could cause a "positive" pregnancy test result, when you are not pregnant. If a pregnancy test comes back positive, and for any reason you and/or the research staff believes that this may be an error, additional tests may be done to confirm or rule out pregnancy. The participant's tumor will be measured using CT, PET/CT or MRI scans. Participants will also have an EKG (heart function test) and a MUGA scan or echocardiogram.
A treatment cycle on this study is 3 weeks. Participants will receive pre-medications of dexamethasone and diphenhydramine prior to the infusion of DOTAP:Chol-fus1 to try to lessen the potential reactions to the infusion. The participant will receive a short infusion of DOTAP:Chol-fus1 by vein once every 3 weeks. Participants will be examined by their doctor before each treatment. In addition, participants will return to the clinic on days 2, 3, and 8 after the first dose to have blood tests done, their vital signs checked, and to look for side effects. After every two treatment cycles or 6 weeks, the participant's tumor will be measured using a CT or MRI scan. Participants can continue to receive treatments until the tumor gets worse, side effects become too severe, or a maximum of 6 treatments have been given. Treatment may continue for participants who continue to benefit from the treatment at the end of the planned 6 treatments if the treating physician, the principle investigator, and an advisor from the FDA all agree. Participants will return to the clinic 3 weeks after their last dose of DOTAP:Chol-fus1 to have their vital signs checked and to look for side effects. After all treatments are finished, participants will be contacted every 3 months for an update on their health and to gather information about any other treatment(s) they have received.
Participants entered at a given dose level will not be able to receive a higher dose while on study. A group of 3 participants will receive DOTAP:Chol-fus1 by vein at each dose level. After treating 3 participants at a given dose level, the participants will be observed for 2 weeks to evaluate the toxicity. The information showing if the participants develop severe side effects, referred to as dose-limiting toxicity (DLT), will be recorded for computing the chance of toxicity. This information will be used to help select the dose level for the next group of participants. The goal is to find the dose level where 10% of participants develop severe side effects (dose-limiting toxicity).
All the participants will be treated in a dose-escalation fashion starting from the lowest level. The next dose level can be moved up if calculation of the side effects shows that a higher dose is needed. However, no skipping of doses is allowed.
This is an investigational study. Up to 51 individuals will receive study drug on this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- DOTAP:Chol-fus1
- Keywords
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Lung Cancer, NSCLC, SCLC, DOTAP:Chol-fus1, gene, gene transfer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOTAP:Chol-fus1Genetic
Also called DOTAP:Chol-FUS1 Liposomes
Infusion of DOTAP:Chol-fus1 by vein once every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DOTAP:Chol-fus1 | Experimental | Infusion intravenous once every 3 weeks Receives: Genetic: DOTAP:Chol-fus1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of DOTAP:Chol-fus1
Measured: Before each dose level (3 weeks); Days 2, 3, and 8 after first dose, blood tests, vital signs, and side effects; and after every two treatment cycles or 6 weeks, tumor measured using CT or MRI scan.
Secondary outcomes (1)
Toxicity of the Intravenous DOTAP:Chol-fus1 complex
Measured: Observation for 2 weeks follwing each treatment cycle (3 weeks) for toxicity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2003 (estimated)
- Study startMar 2003
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David J. Stewart, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059605
- Sponsor's protocol ID
- ID00-123
- Status last verified
- Feb 2012
- First submitted
- 29 Apr 2003
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lu C, Stewart DJ, Lee JJ, Ji L, Ramesh R, Jayachandran G, Nunez MI, Wistuba II, Erasmus JJ, Hicks ME, Grimm EA, Reuben JM, Baladandayuthapani V, Templeton NS, McMannis JD, Roth JA. Phase I clinical trial of systemically administered TUSC2(FUS1)-nanoparticles mediating functional gene transfer in humans. PLoS One. 2012;7(4):e34833. doi: 10.1371/journal.pone.0034833. Epub 2012 Apr 25.
PubMed 22558101
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of Intravenous DOTAP:Cholesterol-Fus1 Liposome Complex (DOTAP:Chol-fus1) In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT00059605
- Acronym / sponsor ID
- ID00-123
- Conditions
- Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Lung Cancer, NSCLC, SCLC, DOTAP:Chol-fus1, gene, gene transfer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2003
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 Apr 2003 (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.
The goal of this clinical research study is to find out the highest safe dose of DOTAP:Chol-fus1 that can be given to participants in the treatment of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC). This study is an attempt to transfer a gene (fus1) into cancer cells, using the drug DOTAP:Cholesterol-fus1. Researchers will also study the side effects of this experimental gene transfer at different doses, and will conduct tests to see if there are any effects on tumor size at different doses. Experimental transfer of the fus1 gene into humans has never been tried before.
Objectives:
- Assess the toxicity of DOTAP:Cholesterol-fus1 Liposome Complex (DOTAP:Chol-fus1) administered intravenously.
- To determine the maximal tolerated dose and recommended phase II dose of DOTAP:Chol-fus1 administered intravenously.
- Assess the expression of fus1 following intravenous delivery of DOTAP:Chol-fus1 in tumor and normal bronchial epithelial cell biopsies.
- Assess any anti-cancer activity for DOTAP:Chol-fus1.
Detailed description
DOTAP:Chol-fus1 is a drug that helps transfer the fus1 gene into cancer cells. It is thought that the absence of the fus1 gene may be involved in the development of lung cancer tumors. The idea is to try to replace this gene in lung cancer cells.
Participants in this study must have advanced lung cancer that has worsened after receiving prior chemotherapy. Before treatment begins, participants will have a physical exam. Blood (about 2 tablespoons) and urine tests will be performed. Women able to have children will have a blood pregnancy test. Please note that it is possible that the tumor could cause a "positive" pregnancy test result, when you are not pregnant. If a pregnancy test comes back positive, and for any reason you and/or the research staff believes that this may be an error, additional tests may be done to confirm or rule out pregnancy. The participant's tumor will be measured using CT, PET/CT or MRI scans. Participants will also have an EKG (heart function test) and a MUGA scan or echocardiogram.
A treatment cycle on this study is 3 weeks. Participants will receive pre-medications of dexamethasone and diphenhydramine prior to the infusion of DOTAP:Chol-fus1 to try to lessen the potential reactions to the infusion. The participant will receive a short infusion of DOTAP:Chol-fus1 by vein once every 3 weeks. Participants will be examined by their doctor before each treatment. In addition, participants will return to the clinic on days 2, 3, and 8 after the first dose to have blood tests done, their vital signs checked, and to look for side effects. After every two treatment cycles or 6 weeks, the participant's tumor will be measured using a CT or MRI scan. Participants can continue to receive treatments until the tumor gets worse, side effects become too severe, or a maximum of 6 treatments have been given. Treatment may continue for participants who continue to benefit from the treatment at the end of the planned 6 treatments if the treating physician, the principle investigator, and an advisor from the FDA all agree. Participants will return to the clinic 3 weeks after their last dose of DOTAP:Chol-fus1 to have their vital signs checked and to look for side effects. After all treatments are finished, participants will be contacted every 3 months for an update on their health and to gather information about any other treatment(s) they have received.
Participants entered at a given dose level will not be able to receive a higher dose while on study. A group of 3 participants will receive DOTAP:Chol-fus1 by vein at each dose level. After treating 3 participants at a given dose level, the participants will be observed for 2 weeks to evaluate the toxicity. The information showing if the participants develop severe side effects, referred to as dose-limiting toxicity (DLT), will be recorded for computing the chance of toxicity. This information will be used to help select the dose level for the next group of participants. The goal is to find the dose level where 10% of participants develop severe side effects (dose-limiting toxicity).
All the participants will be treated in a dose-escalation fashion starting from the lowest level. The next dose level can be moved up if calculation of the side effects shows that a higher dose is needed. However, no skipping of doses is allowed.
This is an investigational study. Up to 51 individuals will receive study drug on this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOTAP:Chol-fus1 | Experimental | Genetic: DOTAP:Chol-fus1Infusion intravenous once every 3 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically or cytologically documented non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
- For NSCLC subjects: Locally advanced, unresectable, incurable stage IIIB (pleural effusion) or stage IV NSCLC, or recurrent NSCLC that is not potentially curable by radiotherapy or surgery. Patients must have received at least one prior platinum-based chemotherapy regimen for NSCLC. For SCLC subjects: Extensive disease or recurrent disease after initial treatment for limited disease. Patients must have received prior platinum-based chemotherapy or chemoradiotherapy. All subjects: There is no limit to the number of prior chemotherapy regimens received.
- Preference will be given to patients with tumors amenable to biopsy. In the expansion cohort at MTD, all patients must have tumor amenable to biopsy and must consent to biopsy.
- Karnofsky Performance Status >= 70%, or Zubrod Performance Status <= 1.
- Negative serum pregnancy test (serum HCG) if female and of childbearing potential. Since beta-HCG may be falsely elevated as a result of malignancy, women of child-bearing potential who have an elevated serum beta-HCG level are eligible for enrollment if they have two Transvaginal Ultrasound (TVUS) scans one week apart and serial beta-HCG levels two weeks apart that are inconsistent with pregnancy and a Gynecology consult to ensure that the beta- HCG level was at a value high enough to see pregnancy with TVUS. Subjects must agree to practice effective birth control during the study period.
Key exclusion criteria (10 listed)
- Females who are pregnant or breast-feeding.
- Patients who received investigational therapy, monoclonal antibody such as bevacizumab or cetuximab, or who received radiotherapy to the skull, spine, thorax or pelvis within 30 days of entry into the protocol. Patients are permitted to have received palliative radiotherapy to an extremity provided at least 14 days has elapsed since completion of therapy, provided the patient received no more than 10 radiotherapy fractions and a dose no higher than 30 Gy to that site, and provided skull, spine, thorax or pelvis were not in the radiotherapy field.
- Patients with brain metastases (except as allowed in inclusion criterion #11). Neurological assessment will be used to determine brain metastases.
- Active systemic viral, bacterial or fungal infections requiring treatment.
- Patients with serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the investigator, would not permit adequate follow-up and compliance with the study protocol.
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 |
|---|---|---|
| DOTAP:Chol-fus1Also: DOTAP:Chol-FUS1 LiposomesInfusion of DOTAP:Chol-fus1 by vein once every 3 weeks. | Genetic | DOTAP:Chol-fus1 |
Primary outcome
Maximum Tolerated Dose of DOTAP:Chol-fus1
Time frame: Before each dose level (3 weeks); Days 2, 3, and 8 after first dose, blood tests, vital signs, and side effects; and after every two treatment cycles or 6 weeks, tumor measured using CT or MRI scan.
1 secondary outcome
Toxicity of the Intravenous DOTAP:Chol-fus1 complex
Time frame: Observation for 2 weeks follwing each treatment cycle (3 weeks) for toxicity.
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 23 Feb 2012.
- Derived from this study: PubMed 22558101Lu C, Stewart DJ, Lee JJ, Ji L, Ramesh R, Jayachandran G, Nunez MI, Wistuba II, Erasmus JJ, Hicks ME, Grimm EA, Reuben JM, Baladandayuthapani V, Templeton NS, McMannis JD, Roth JA. Phase I clinical trial of systemically administered TUSC2(FUS1)-nanoparticles mediating functional gene transfer in humans. PLoS One. 2012;7(4):e34833. doi: 10.1371/journal.pone.0034833. Epub 2012 Apr 25.
- UT M.D.Anderson Cancer CenterLink provided by the sponsor.
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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.
David J. Stewart, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DOTAP:Chol-fus1 in people with Lung Cancer, run by M.D. Anderson Cancer 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 13 inclusion and 10 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 23 Feb 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum Tolerated Dose of DOTAP:Chol-fus1 (time frame: Before each dose level (3 weeks); Days 2, 3, and 8 after first dose, blood tests, vital signs, and side effects; and after every two treatment cycles or 6 weeks, tumor measured using CT or MRI scan.). 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 NCT00059605, which also lists 1 linked publication.
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 23 Feb 2012.