Pancreatic CancerPhase 1NCT00027521
Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
A Phase 1 study testing bleomycin sulfate and electroporation therapy in people with Pancreatic Cancer, run by Ichor Medical Systems Incorporated.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- bleomycin sulfate and electroporation therapy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to not given
- 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
DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the pancreas Unresectable disease by exploratory laparotomy Involvement of the superior mesenteric artery or occlusion of the superior mesenteric vein-portal vein confluence No extrapancreatic metastases by ultrasound, CT scan, or laparotomy Tumor must be accessible for direct injection of study drug and placement of electrode array
PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: AST and ALT no greater than 3 times upper limit of normal No impaired hepatic function Renal: Creatinine no greater than 1.5 mg/dL No impaired renal function Cardiovascular: No impaired cardiac function Pulmonary: No compromised pulmonary function No pulmonary condition that would potentially require the use of high FIO2 levels Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No prior reaction to bleomycin No fever, infection, or other medical condition that would preclude study Not at high risk for complications associated with abdominal surgery
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior lifetime cumulative dose of bleomycin greater than 400 U Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
About this study
Official title: Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of electroporation therapy and bleomycin in treating patients who have locally advanced pancreatic cancer.
Read the detailed description
OBJECTIVES: I. Determine the safety and surgical feasibility of electroporation therapy with bleomycin in patients with locally advanced pancreatic cancer. II. Determine the overall and progression-free survival of patients treated with this regimen.
OUTLINE: Patients receive bleomycin intratumorally during laparotomy. Approximately 15 minutes after the intratumoral injection, patients receive bleomycin IV over 10 minutes. Approximately 5 minutes after the IV injection, patients undergo electroporation therapy comprising electrical pulses directly to the pancreas and surrounding tissues. Patients are followed weekly for 4-6 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12-18 months.
- Conditions
- Pancreatic Cancer
- Being tested
- bleomycin sulfate, electroporation therapy
- Keywords
- stage III pancreatic cancer, adenocarcinoma of the pancreas
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
electroporation therapyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2003 (estimated)
- Study startDec 2000
Why it stopped: Program terminated
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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ichor Medical Systems Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Richard C. Karl, MD, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00027521
- Sponsor's protocol ID
- CDR0000069037
- Other IDs
- ICHOR-MCC-12305, MCC-12305, MCC-IRB-5948, NCI-V01-1672
- Status last verified
- Sep 2012
- First submitted
- 7 Dec 2001
- Last updated
- 19 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00027521
- Acronym / sponsor ID
- CDR0000069037
- Conditions
- Pancreatic Cancer
- Keywords
- stage III pancreatic cancer, adenocarcinoma of the pancreas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Program terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ichor Medical Systems IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2000
- First posted
- 21 Nov 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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of electroporation therapy and bleomycin in treating patients who have locally advanced pancreatic cancer.
Detailed description
OBJECTIVES: I. Determine the safety and surgical feasibility of electroporation therapy with bleomycin in patients with locally advanced pancreatic cancer. II. Determine the overall and progression-free survival of patients treated with this regimen.
OUTLINE: Patients receive bleomycin intratumorally during laparotomy. Approximately 15 minutes after the intratumoral injection, patients receive bleomycin IV over 10 minutes. Approximately 5 minutes after the IV injection, patients undergo electroporation therapy comprising electrical pulses directly to the pancreas and surrounding tissues. Patients are followed weekly for 4-6 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12-18 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| bleomycin sulfate | Biological | – |
| electroporation therapy | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
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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.
Richard C. Karl, MD study chair
H. Lee Moffitt Cancer Center and Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bleomycin sulfate and electroporation therapy in people with Pancreatic Cancer, run by Ichor Medical Systems Incorporated.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 19 Sep 2012.