Metastases, NeoplasmPhase 1/2NCT00041808
Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver
A Phase 1/2 study testing MTC-DOX for Injection and Chemotherapy in people with Metastases, Neoplasm and Colorectal Neoplasms, run by FeRx at 4 sites in 2 countries.
Trial summary
MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastases, Neoplasm, Colorectal Neoplasms, Esophageal Neoplasms
- What is being tested?
- MTC-DOX for Injection and Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2001to Apr 2003
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a Karnofsky (or equivalent) performance status > 60 and an expected survival of > 2 months
- Patients agreeing to use a medically effective method of contraception
- Patients able to understand and give written informed consent
- The center of the tumor mass must be < or = 14 cm from the anterior or lateral abdominal wall as determined by cross sectional imaging measured at baseline. This is required for optimal retention of MTC-DOX by the magnetic field. If more than one tumor mass is present, all of the treated tumor masses must meet this criterion
Who cannot join
- Women who are pregnant or lactating
- Patient's with metastatic liver cancer, or other primary liver cancer excluding HCC, with diffuse disease that does not have focal area(s) conducive to local regional therapy
- Patients with the following laboratory abnormalities:Hemoglobin < 10.0 g/dL;Granulocyte count < 1,500 per mm3;Platelet count < 50,000 per mm3; Lymphocyte count < 0.5 x 10 to the 9th per L; Total bilirubin >/= 3.0 mg/dL;AST or ALT >/= 5x the upper limit of normal;INR >/= 1.3; Creatinine >/= 2.0 mg/dL
- Patients with either significant cardiovascular disease or any other organ system dysfunction which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the test material. Patients with evidence of a myocardial infarction within six (6) months prior to this trial will be excluded.
- Patients with an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other indwelling device or appliance that could be adversely affected by the use of the external magnet
- Patients at the time of study entry with a second invasive cancer other than basal cell and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
Show all 9Show fewer
- Patients with documented evidence of hemachromatosis or hemosiderosis
- Patients with CT or ultrasound evidence of portal vein invasion or thrombosis
- Patients who have had prior anthracycline therapy with a left ventricular ejection fraction (LVEF) <50%, as measured by either multigated radionuclide angiography (MUGA) scan or echocardiogram.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Scripps Stevens Cancer Division
San Diego, California, 92037
UCSF Cancer Center
San Francisco, California, 94143
Scott and White Clinic
Temple, Texas, 76508
About this study
Official title: A Phase I/II Single Dose Trial to Determine The Safety, Tolerance, Pharmacokinetic Profile, and Preliminary Activity of Intrahepatic Delivery (Via Hepatic Artery Catheterization) of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers ( MTC-DOX) in Patients With Metastatic Cancer to the Liver .
MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then "leaks" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free from" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties, making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and provide a treatment to patients with cancers that have spread to the liver.
- Conditions
- Metastases, Neoplasm, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Breast Neoplasms
- Being tested
- MTC-DOX for Injection, Chemotherapy
- Keywords
- Metastatic liver cancer, Cholangiocarcinoma, colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, breast cancer, malignant melanoma, sarcoma, GIST, gastrointestinal stromal tumor, lung cancer, liver cancer
- Medical subject headings
- Neoplasm Metastasis, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Breast Neoplasms, Melanoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTC-DOX for InjectionDrug
ChemotherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2002 (estimated)
- Study startJul 2001
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastases, NeoplasmStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- FeRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joy Koda, PhD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041808
- Sponsor's protocol ID
- MTC-DOX-003
- Status last verified
- Feb 2003
- First submitted
- 17 Jul 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Single Dose Trial to Determine The Safety, Tolerance, Pharmacokinetic Profile, and Preliminary Activity of Intrahepatic Delivery (Via Hepatic Artery Catheterization) of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers ( MTC-DOX) in Patients With Metastatic Cancer to the Liver .
- ClinicalTrials.gov ID
- NCT00041808
- Acronym / sponsor ID
- MTC-DOX-003
- Conditions
- Metastases, Neoplasm, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Breast Neoplasms
- Keywords
- Metastatic liver cancer, Cholangiocarcinoma, colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, breast cancer, malignant melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- FeRxIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Study completion
- Apr 2003
- First posted
- 19 Jul 2002 (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.
MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then "leaks" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free from" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties, making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and provide a treatment to patients with cancers that have spread to the liver.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a Karnofsky (or equivalent) performance status > 60 and an expected survival of > 2 months
- Patients agreeing to use a medically effective method of contraception
- Patients able to understand and give written informed consent
- The center of the tumor mass must be < or = 14 cm from the anterior or lateral abdominal wall as determined by cross sectional imaging measured at baseline. This is required for optimal retention of MTC-DOX by the magnetic field. If more than one tumor mass is present, all of the treated tumor masses must meet this criterion
Key exclusion criteria (9 listed)
- Women who are pregnant or lactating
- Patient's with metastatic liver cancer, or other primary liver cancer excluding HCC, with diffuse disease that does not have focal area(s) conducive to local regional therapy
- Patients with the following laboratory abnormalities:Hemoglobin < 10.0 g/dL;Granulocyte count < 1,500 per mm3;Platelet count < 50,000 per mm3; Lymphocyte count < 0.5 x 10 to the 9th per L; Total bilirubin >/= 3.0 mg/dL;AST or ALT >/= 5x the upper limit of normal;INR >/= 1.3; Creatinine >/= 2.0 mg/dL
- Patients with either significant cardiovascular disease or any other organ system dysfunction which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the test material. Patients with evidence of a myocardial infarction within six (6) months prior to this trial will be excluded.
- Patients with an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other indwelling device or appliance that could be adversely affected by the use of the external magnet
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 |
|---|---|---|
| MTC-DOX for Injection | Drug | – |
| Chemotherapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
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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.
Joy Koda, PhD study chair
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MTC-DOX for Injection and Chemotherapy in people with Metastases, Neoplasm and Colorectal Neoplasms, run by FeRx at 4 sites in 2 countries.
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 4 inclusion and 9 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. 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 combined 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.
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.
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 24 Jun 2005.