Pancreatic CancerPhase 1NCT00121745
Evaluation of Safety of Rexin-G Gene Transfer for Advanced Pancreatic Cancer
A Phase 1 study testing Rexin-G Dose 1, Rexin-G Dose 2 and Rexin-G Dose 3 in people with Pancreatic Cancer, run by Epeius Biotechnologies at 1 site in United States.
Trial summary
This is a dose-seeking study that will test the safety of increasing doses of Rexin-G, given intravenously, in patients with advanced or metastatic pancreatic cancer who have failed standard chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Rexin-G Dose 1, Rexin-G Dose 2 and Rexin-G Dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Locally advanced or metastatic pancreatic cancer.
- Histologic or cytologic confirmation at diagnosis or recurrence of pancreatic cancer
- Measurable disease (RECIST) criteria. Tumor lesions that are situated in a previously irradiated area are not considered measurable, except if there is radiologically confirmed progression of disease within the radiation fields after radiation was completed.
- Failed gemcitabine chemotherapy as indicated by disease progression ≤ 6 months from last gemcitabine treatment
- Two or less than 2 chemotherapy regimens for recurrent/progressive disease.
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- Adequate hepatic function based on laboratory values obtained less than 7 days prior to registration:
- Total bilirubin <2.0 mg/dL;
- AST < 2 x ULN;
- AST < 2 x ULN;
- Hgb > 9.0 gm/dL;
- PT < ULN;
- PTT <ULN;
- Albumin > 3.0 gm/dL;
- Alkaline phosphatase < 3 x ULN;
- Absolute granulocyte count > 1000/uL;
- Platelet count > 100,000/uL;
- Serum creatinine < 1.2 mg/dL for females; < 1.4 mg/dL for males.
- ECOG performance status (PS) 0 or 1.
- Ability to provide informed consent.
- Life expectancy 12 weeks or greater.
- Male participants should be willing to provide semen samples at required intervals. Inability of the patient to provide all semen samples does not make the patient ineligible. (EXCEPTION: If the patient has been vasectomized. To be noted in the study file).
- Fertile patients agree to use barrier contraception (condoms plus spermicidal jelly) during the vector infusion period and for six weeks after infusion.
- Accessibility of peripheral or central IV line which is adequate for infusions of investigational agent.
Who cannot join
- Prior malignancy. (EXCEPTION: Patients who are disease free ≥ 5 years and/or patients with non-melanoma skin cancer, Stage I breast cancer, CIS of cervix)
- Any of the following:
- Pregnant women;
- Nursing women;
- Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.). This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
- Patients who are HIV+, HBV+ or HCV+.
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- Clinically significant ascites causing symptoms or requiring therapeutic paracentesis.
- Medical, psychiatric, or social conditions that would compromise successful adherence to this protocol.
- Concomitant use of other chemotherapeutic, viral or immunotherapeutic agents is not allowed during the 6-week study period.
- ≤ 4 weeks from radiation therapy of their pancreatic primary or ≤ 2 weeks from palliative radiation therapy to metastatic sites.
- ≤ 4 weeks from prior chemotherapy.
- History of congestive heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Evaluation of Safety of Intravenous Infusion of a Pathotropic Vector Bearing a Cytocidal Cyclin G1 Construct (Rexin-G) as Intervention for Locally Advanced and Metastatic Pancreatic Cancer Refractory to Standard Chemotherapy
This is a dose-seeking study that will test the safety of increasing doses of Rexin-G, given intravenously, in patients with advanced or metastatic pancreatic cancer who have failed standard chemotherapy. Rexin-G is a tumor-targeted gene therapy vector that contains a "killer" gene that blocks the action of the human cyclin G1 gene. Cyclin G1 is a cell cycle control element that plays an important role in cancer growth. When injected into a vein, the Rexin-GTM vector seeks out and accumulates in cancerous tumors, therefore, increasing the concentration of the drug in the cancerous tumors and not in normal neighbouring organs.
Read the detailed description
Pancreatic cancer is the fourth leading cause of cancer death in the United States. Every year, about 30,000 new patients are diagnosed with pancreatic cancer, and most will die within the year. The few patients that live beyond one year are those who have operable tumors whose cancer has not spread beyond the pancreas. There is no effective treatment for pancreatic cancer that impacts survival beyond a few more months. Therefore, innovative treatments are urgently needed. A number of experimental therapies are currently under investigation, and gene therapy is a viable therapeutic option.
A gene called cyclin G1 has been shown to play a very important part in cancer growth. In animal experiments, when this cyclin G1 gene is blocked, the cancer cells grow much slower or even die. This study will test the drug, Rexin-G, which contains a gene that works by getting rid of the cyclin G1 gene. The new gene will get into the tumor cells using a "vehicle" to carry it into the cells. The "vehicle" that will be used is a virus that has been changed so that it is not likely to cause disease. This "vehicle" is called a vector. When injected into a vein, the Rexin-G vector is designed to seek out and accumulate in cancerous tumors, therefore, increasing the concentration of the drug in the area of the cancer and not in normal neighbouring organs. When the killer gene gets into the cancer cell, it becomes part of the cell's genes and tells the cancer cell to begin using the new gene instead of the cyclin G1 gene. It is hoped that the Rexin-G will arrest the growth of the cancer or eradicate the tumor.
The goals of the study are to determine how much Rexin-G can be given to a patient, to assess how long Rexin-G stays in the body when injected into a vein, and if the drug would cause antibodies to form, transfer the gene to normal tissues or pass on the gene to another person or the person's offspring. The final goal is to determine if the Rexin-G vector can shrink the tumor by comparing the size of the tumor nodules measured by CT scan or MRI before and after the Rexin-G treatment.
- Conditions
- Pancreatic Cancer
- Being tested
- Rexin-G Dose 1, Rexin-G Dose 2, Rexin-G Dose 3, Rexin-G Dose 4
- Keywords
- gene transfer, cell cycle control, cancer gene therapy, pathotropic targeting, tumor targeted retroviral vector
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rexin-G Dose 1Genetic
Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose I 3- 6 Days 1-7, 15-21 7.5 x 10e9 cfu 500 ml
Rexin-G Dose 2Genetic
Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose II 3- 6 Days 1-7, 15-21 1.1 x 10e10 cfu 500 ml
Rexin-G Dose 3Genetic
Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose
III 3- 6 5 days/wk x 4 wks 3.0 x 10e10 cfu 500 ml
Rexin-G Dose 4Genetic
Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose
IV 3- 6 5 days/wk x 4 wks 8.0 x 10e10 cfu 500 ml
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Genetic: Rexin-G Dose 1 |
| 2 | Experimental | Not described Receives: Genetic: Rexin-G Dose 2 |
| 3 | Experimental | Not described Receives: Genetic: Rexin-G Dose 3 |
| 4 | Experimental | Not described Receives: Genetic: Rexin-G Dose 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the dose limiting toxicity and maximum tolerated dose of Rexin-G administered as intravenous infusions; To evaluate pharmacokinetics of Rexin-G
Measured: 22 months
Secondary outcomes (1)
To assess anti-tumor activity of intravenously administered Rexin-G and obtain preliminary data on biochemical markers of tumor response
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJul 2005
- Study completionJul 2007
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epeius Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Evanthia Galanis, M.D., Principal investigator, Mayo Clinic - Rochester, Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121745
- Sponsor's protocol ID
- MC044C
- Status last verified
- Dec 2007
- First submitted
- 15 Jul 2005
- Last updated
- 20 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Safety of Intravenous Infusion of a Pathotropic Vector Bearing a Cytocidal Cyclin G1 Construct (Rexin-G) as Intervention for Locally Advanced and Metastatic Pancreatic Cancer Refractory to Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT00121745
- Acronym / sponsor ID
- MC044C
- Conditions
- Pancreatic Cancer
- Keywords
- gene transfer, cell cycle control, cancer gene therapy, pathotropic targeting, tumor targeted retroviral vector
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Epeius BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Jul 2005 (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 is a dose-seeking study that will test the safety of increasing doses of Rexin-G, given intravenously, in patients with advanced or metastatic pancreatic cancer who have failed standard chemotherapy. Rexin-G is a tumor-targeted gene therapy vector that contains a "killer" gene that blocks the action of the human cyclin G1 gene. Cyclin G1 is a cell cycle control element that plays an important role in cancer growth. When injected into a vein, the Rexin-GTM vector seeks out and accumulates in cancerous tumors, therefore, increasing the concentration of the drug in the cancerous tumors and not in normal neighbouring organs.
Detailed description
Pancreatic cancer is the fourth leading cause of cancer death in the United States. Every year, about 30,000 new patients are diagnosed with pancreatic cancer, and most will die within the year. The few patients that live beyond one year are those who have operable tumors whose cancer has not spread beyond the pancreas. There is no effective treatment for pancreatic cancer that impacts survival beyond a few more months. Therefore, innovative treatments are urgently needed. A number of experimental therapies are currently under investigation, and gene therapy is a viable therapeutic option.
A gene called cyclin G1 has been shown to play a very important part in cancer growth. In animal experiments, when this cyclin G1 gene is blocked, the cancer cells grow much slower or even die. This study will test the drug, Rexin-G, which contains a gene that works by getting rid of the cyclin G1 gene. The new gene will get into the tumor cells using a "vehicle" to carry it into the cells. The "vehicle" that will be used is a virus that has been changed so that it is not likely to cause disease. This "vehicle" is called a vector. When injected into a vein, the Rexin-G vector is designed to seek out and accumulate in cancerous tumors, therefore, increasing the concentration of the drug in the area of the cancer and not in normal neighbouring organs. When the killer gene gets into the cancer cell, it becomes part of the cell's genes and tells the cancer cell to begin using the new gene instead of the cyclin G1 gene. It is hoped that the Rexin-G will arrest the growth of the cancer or eradicate the tumor.
The goals of the study are to determine how much Rexin-G can be given to a patient, to assess how long Rexin-G stays in the body when injected into a vein, and if the drug would cause antibodies to form, transfer the gene to normal tissues or pass on the gene to another person or the person's offspring. The final goal is to determine if the Rexin-G vector can shrink the tumor by comparing the size of the tumor nodules measured by CT scan or MRI before and after the Rexin-G treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Genetic: Rexin-G Dose 1 |
| 2 | Experimental | Genetic: Rexin-G Dose 2 |
| 3 | Experimental | Genetic: Rexin-G Dose 3 |
| 4 | Experimental | Genetic: Rexin-G Dose 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age 18 years or older.
- Locally advanced or metastatic pancreatic cancer.
- Histologic or cytologic confirmation at diagnosis or recurrence of pancreatic cancer
- Measurable disease (RECIST) criteria. Tumor lesions that are situated in a previously irradiated area are not considered measurable, except if there is radiologically confirmed progression of disease within the radiation fields after radiation was completed.
- Failed gemcitabine chemotherapy as indicated by disease progression ≤ 6 months from last gemcitabine treatment
Key exclusion criteria (12 listed)
- Prior malignancy. (EXCEPTION: Patients who are disease free ≥ 5 years and/or patients with non-melanoma skin cancer, Stage I breast cancer, CIS of cervix)
- Any of the following:
- Patients who are HIV+, HBV+ or HCV+.
- Clinically significant ascites causing symptoms or requiring therapeutic paracentesis.
- Medical, psychiatric, or social conditions that would compromise successful adherence to this 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 |
|---|---|---|
| Rexin-G Dose 1Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose I 3- 6 Days 1-7, 15-21 7.5 x 10e9 cfu 500 ml | Genetic | 1 |
| Rexin-G Dose 2Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose II 3- 6 Days 1-7, 15-21 1.1 x 10e10 cfu 500 ml | Genetic | 2 |
| Rexin-G Dose 3Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose III 3- 6 5 days/wk x 4 wks 3.0 x 10e10 cfu 500 ml | Genetic | 3 |
| Rexin-G Dose 4Dose Level # Patients Treatment Days Vector Dose/Day Max.Volume/Dose IV 3- 6 5 days/wk x 4 wks 8.0 x 10e10 cfu 500 ml | Genetic | 4 |
Primary outcome
To determine the dose limiting toxicity and maximum tolerated dose of Rexin-G administered as intravenous infusions; To evaluate pharmacokinetics of Rexin-G
Time frame: 22 months
1 secondary outcome
To assess anti-tumor activity of intravenously administered Rexin-G and obtain preliminary data on biochemical markers of tumor response
Time frame: 22 months
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2007.
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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.
Evanthia Galanis, M.D. principal investigator
Mayo Clinic - Rochester, Minnesota
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 Rexin-G Dose 1, Rexin-G Dose 2 and Rexin-G Dose 3 in people with Pancreatic Cancer, run by Epeius Biotechnologies 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 24 inclusion and 12 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: stopped early, as of the sponsor's last update on 20 Dec 2007. 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 was stopped early (reason given: poor enrollment). Results are not available in the source record.
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 determine the dose limiting toxicity and maximum tolerated dose of Rexin-G administered as intravenous infusions; To evaluate pharmacokinetics of Rexin-G (time frame: 22 months). It is what the study was designed to measure, not a finding.
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 20 Dec 2007.