Metastatic CancerPhase 2NCT00265863
Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
A Phase 2 study testing mitomycin C in people with Metastatic Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin, may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- mitomycin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Aug 2005
- 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
Who may be able to join
- Diagnosis of peritoneal metastases and malignant ascites by physical examination, ultrasound, or CT scan
- Not eligible for cytoreductive surgery based on any of the following criteria:
- Metastases outside peritoneal cavity
- Poor performance status
- Unresectable peritoneal disease
- Must have undergone at least 1 prior paracentesis procedure
Show all 18Show fewer
- No ascites caused by any of the following conditions:
- Cardiac failure
- Nephrotic syndrome
- Pancreatic ascites
- Chylous ascites
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 70,000/mm^3
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
Who cannot join
- Prior peritoneal chemotherapy
- Dense intraabdominal adhesions limiting laparoscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin, may kill more tumor cells.
PURPOSE: This phase II trial is studying how well mitomycin works when given as a hyperthermic peritoneal perfusion in treating patients with malignant ascites.
Read the detailed description
OBJECTIVES:
Primary
- Determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin C in preventing relapse at 4 weeks post-treatment in patients with malignant ascites.
Secondary
- Determine any improvement in the quality of life of patients treated with this procedure.
OUTLINE: This is a nonrandomized study.
Patients undergo laparoscopic surgery to remove ascitic fluid and any intraabdominal adhesions and to place 2 inflow and 2 outflow catheters. Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
Quality of life is assessed at study entry and at 4 weeks.
After completion of study treatment, patients are followed periodically for 2 years.
- Conditions
- Metastatic Cancer
- Being tested
- mitomycin C
- Keywords
- malignant ascites
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitomycin CDrug
Also called MTC
Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Malignant Ascites | Experimental | Patients meeting protocol criteria enrolled with malignant ascites. Receives: Drug: mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of malignant recurrence
Measured: Week 4 after treatment
Secondary outcomes (2)
Quality of life after treatment
Measured: Week 4 after treatment
Comparison of serum vascular endothelial growth factor (VEGF) levels
Measured: Pretreatment and Week 4 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startAug 2004
- Primary completionAug 2005
- Study completionAug 2005
Why it stopped: Withdrawn due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Todd M. Tuttle, MD, Study chair, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265863
- Sponsor's protocol ID
- 2004LS043
- Status last verified
- Nov 2017
- First submitted
- 14 Dec 2005
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Laparoscopic Hyperthermic Peritoneal Chemotherapy for Malignant Ascites
- ClinicalTrials.gov ID
- NCT00265863
- Acronym / sponsor ID
- 2004LS043
- Conditions
- Metastatic Cancer
- Keywords
- malignant ascites
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn due to slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 15 Dec 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.
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin, may kill more tumor cells.
PURPOSE: This phase II trial is studying how well mitomycin works when given as a hyperthermic peritoneal perfusion in treating patients with malignant ascites.
Detailed description
OBJECTIVES:
Primary
- Determine the effectiveness of laparoscopic hyperthermic perfusion of mitomycin C in preventing relapse at 4 weeks post-treatment in patients with malignant ascites.
Secondary
- Determine any improvement in the quality of life of patients treated with this procedure.
OUTLINE: This is a nonrandomized study.
Patients undergo laparoscopic surgery to remove ascitic fluid and any intraabdominal adhesions and to place 2 inflow and 2 outflow catheters. Mitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes.
Quality of life is assessed at study entry and at 4 weeks.
After completion of study treatment, patients are followed periodically for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Malignant Ascites | Experimental | Drug: mitomycin CPatients meeting protocol criteria enrolled with malignant ascites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of peritoneal metastases and malignant ascites by physical examination, ultrasound, or CT scan
- Not eligible for cytoreductive surgery based on any of the following criteria:
- Must have undergone at least 1 prior paracentesis procedure
- No ascites caused by any of the following conditions:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
Key exclusion criteria (2 listed)
- Prior peritoneal chemotherapy
- Dense intraabdominal adhesions limiting laparoscopy
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 |
|---|---|---|
| mitomycin CAlso: MTCMitomycin C is infused into the abdominal cavity by hyperthermic perfusion over 60 minutes. | Drug | Patients with Malignant Ascites |
Primary outcome
Prevention of malignant recurrence
Time frame: Week 4 after treatment
2 secondary outcomes
Quality of life after treatment
Time frame: Week 4 after treatment
Comparison of serum vascular endothelial growth factor (VEGF) levels
Time frame: Pretreatment and Week 4 after treatment
Results and safety
The study was stopped early (reason given: Withdrawn due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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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.
Todd M. Tuttle, MD study chair
Masonic Cancer Center, University of Minnesota
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 mitomycin C in people with Metastatic Cancer, run by Masonic Cancer Center, University of Minnesota 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 18 inclusion and 2 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 29 Nov 2017. 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 was stopped early (reason given: Withdrawn due to slow accrual). 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?
Prevention of malignant recurrence (time frame: Week 4 after treatment). 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 29 Nov 2017.