MelanomaPhase 2NCT00062933
A Phase II Study of Isolated Hepatic Perfusion (IHP) in Patients With Ocular Melanoma
A Phase 2 study testing Laparotomy in people with Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Ocular melanoma, or cancer of the eye, is a rare form of cancer that can spread to the liver. A tumor in the liver, because of its size or location, sometimes cannot be removed with surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Mar 2008
- 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
- Histologically or cytologically proven measurable metastatic ocular melanoma confined to the liver. Patients with limited sites of extra-hepatic disease and who have dominant life-limiting disease in liver will be considered eligible if the extra-hepatic sites can be treated with local ablative measures such as resection or external beam radiation therapy. Patients with limited extra-hepatic disease will undergo IHP and treatment of extra-hepatic disease in a sequence determined by the clinical presentation but all patients will have had all disease treated prior to initiating temozolomide therapy.
- Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy for 28 days prior to the liver perfusion and must have recovered from all side effects except those outlined in appendix III.
- Patients must have an ECOG performance standard of 0,1 or 2 prior to on-study and on the day prior to treatment with IHP.
- Patients must have adequate hepatic function as evidenced by bilirubin less than 2.0 mg/dL and a PT equal to 2 seconds of the upper normal limit AST/ALT less than or equal to 10 times ULN.
- Patients must be 18 years of age or greater and must be greater than 30 kg, because of reason outlined in Section 6.2.
- Patients must have a platelet count greater than 75,000, a HCT greater than 27.0, an ANC greater than or equal to 1,500/ul, and a creatinine less than or equal to 1.5 mg/dL unless the measured creatinine clearance is greater than 60 mL/min/1.73 m(2).
- Patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy , alternative treatments, potential benefits, and risks. The patient must be willing to sign an informed consent.
Who cannot join
- Pregnant patients and nursing mothers will be excluded due to the unknown effects of melphalan on the fetus or newborn.
- Patients taking immunosuppressive drugs or on chronic anticoagulation will not be eligible.
- Patients with active systemic infections are not eligible.
- Patients with biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies will be excluded.
- Patients with a history of congestive heart failure with an LVEF less than 40% will be excluded.
- Patients with COPD or other chronic pulmonary disease with PFT's less than 50% predicted for age will be excluded.
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- Patients with a history or diagnosis of veno-occlusive disease (VOD) will be excluded.
- Patients with chronic active hepatitis based on a positive serology test for surface antigen B or C will be excluded if there is evidence of cirrhosis on pathology. If no pathology specimen exists then evidence for cirrhosis will be determined based on radiological studies and physical examination. If there are no indications of it then the patient will be registered on study and a biopsy will be obtained at the time of laparotomy for IHP with the expectation that occult clinically significant cirrhosis is very unlikely. If cirrhosis is pathologically confirmed the patient will not undergo treastment and be taken off study. Patients with radiographic or other signs of cirrhosis will undergo percutaneous biopsy prior to registration.
- Patients with a prior hypersensitivity reaction to melphalan, dacarbazine, or temozolomide will be ineligible for study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan Followed by Temozolomide for Subjects With Unresectable Hepatic Metastases From Ocular Melanoma
Ocular melanoma, or cancer of the eye, is a rare form of cancer that can spread to the liver. A tumor in the liver, because of its size or location, sometimes cannot be removed with surgery.
The purpose of this study is to determine whether chemotherapy delivered only to the liver, called isolated hepatic perfusion (IHP), followed by systemic (to the whole body) chemotherapy improves the ability to treat cancer.
Read more
Study participants must be 18 years or older and have ocular melanoma that has spread to the liver. Before enrolling in the study, they will undergo the following evaluations: a physical exam; x-rays; blood tests; electrocardiogram; computed tomography (CT) scan of the chest, abdomen and pelvis; and a magnetic resonance imaging (MRI) scan of the liver.
The study includes a 15-minute quality-of-life questionnaire. Participants will complete the questionnaire 7 times over a period of 2 years to help investigators gauge their health status and progress.
A laparotomy is done, which allows a surgeon to view the tumor in the liver through a small incision in the abdomen while the patient is under general anesthesia. Sometimes the tumor can spread outside the liver in a way that cannot be seen by pre-operative scans. When this happens, the participant is ineligible to continue in the study, since an important part of the treatment is given only to the liver.
If the laparotomy reveals that the participant is eligible for the remainder of the study, the participant will receive IHP treatment during the surgery. Plastic tubes called catheters are placed in the vein and artery that feed and drain the liver. This creates a separate blood supply for the liver alone. Heated chemotherapy is then given into the liver blood supply for one hour, while being carefully kept out of the rest of the body.
After recovering from the surgery, eligible participants will receive a systemic chemotherapy called temozolomide for up to one year. This chemotherapy is taken by mouth in capsule form.
Participants will be asked to return to NIH 10-11 times during the first year to evaluate their progress.
Read the detailed description
Patients with unresectable hepatic metastases secondary to ocular melanoma will undergo a 60 minute hyperthermic isolated hepatic perfusion with 1.5mg/kg melphalan followed by up to one year of oral temozolomide. Response to treatment, duration of response, patterns of failure, survival, and quality of life end-points will be followed.
- Conditions
- Melanoma
- Being tested
- Laparotomy
- Keywords
- Clinical Response, Duration of Response, Quality of Life, Hyperthermia, Survival, Melanoma, Ocular Melanoma, Eye Cancer
- Medical subject headings
- Melanoma, Hyperthermia, Uveal Melanoma, Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparotomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2003 (estimated)
- Study startJun 2003
- Primary completionSep 2007
- Study completionMar 2008
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 MelanomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062933
- Sponsor's protocol ID
- 030221
- Other IDs
- 03-C-0221
- Status last verified
- Aug 2012
- First submitted
- 17 Jun 2003
- Last updated
- 20 Aug 2012
- Results posted
- No
Publications
Becker JC, Terheyden P, Kampgen E, Wagner S, Neumann C, Schadendorf D, Steinmann A, Wittenberg G, Lieb W, Brocker EB. Treatment of disseminated ocular melanoma with sequential fotemustine, interferon alpha, and interleukin 2. Br J Cancer. 2002 Oct 7;87(8):840-5. doi: 10.1038/sj.bjc.6600521.
PubMed 12373596
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan Followed by Temozolomide for Subjects With Unresectable Hepatic Metastases From Ocular Melanoma
- ClinicalTrials.gov ID
- NCT00062933
- Acronym / sponsor ID
- 030221
- Conditions
- Melanoma
- Keywords
- Clinical Response, Duration of Response, Quality of Life, Hyperthermia, Survival, Melanoma, Ocular Melanoma, Eye Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 18 Jun 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.
Ocular melanoma, or cancer of the eye, is a rare form of cancer that can spread to the liver. A tumor in the liver, because of its size or location, sometimes cannot be removed with surgery.
The purpose of this study is to determine whether chemotherapy delivered only to the liver, called isolated hepatic perfusion (IHP), followed by systemic (to the whole body) chemotherapy improves the ability to treat cancer.
Study participants must be 18 years or older and have ocular melanoma that has spread to the liver. Before enrolling in the study, they will undergo the following evaluations: a physical exam; x-rays; blood tests; electrocardiogram; computed tomography (CT) scan of the chest, abdomen and pelvis; and a magnetic resonance imaging (MRI) scan of the liver.
The study includes a 15-minute quality-of-life questionnaire. Participants will complete the questionnaire 7 times over a period of 2 years to help investigators gauge their health status and progress.
A laparotomy is done, which allows a surgeon to view the tumor in the liver through a small incision in the abdomen while the patient is under general anesthesia. Sometimes the tumor can spread outside the liver in a way that cannot be seen by pre-operative scans. When this happens, the participant is ineligible to continue in the study, since an important part of the treatment is given only to the liver.
If the laparotomy reveals that the participant is eligible for the remainder of the study, the participant will receive IHP treatment during the surgery. Plastic tubes called catheters are placed in the vein and artery that feed and drain the liver. This creates a separate blood supply for the liver alone. Heated chemotherapy is then given into the liver blood supply for one hour, while being carefully kept out of the rest of the body.
After recovering from the surgery, eligible participants will receive a systemic chemotherapy called temozolomide for up to one year. This chemotherapy is taken by mouth in capsule form.
Participants will be asked to return to NIH 10-11 times during the first year to evaluate their progress.
Detailed description
Patients with unresectable hepatic metastases secondary to ocular melanoma will undergo a 60 minute hyperthermic isolated hepatic perfusion with 1.5mg/kg melphalan followed by up to one year of oral temozolomide. Response to treatment, duration of response, patterns of failure, survival, and quality of life end-points will be followed.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically proven measurable metastatic ocular melanoma confined to the liver. Patients with limited sites of extra-hepatic disease and who have dominant life-limiting disease in liver will be considered eligible if the extra-hepatic sites can be treated with local ablative measures such as resection or external beam radiation therapy. Patients with limited extra-hepatic disease will undergo IHP and treatment of extra-hepatic disease in a sequence determined by the clinical presentation but all patients will have had all disease treated prior to initiating temozolomide therapy.
- Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy for 28 days prior to the liver perfusion and must have recovered from all side effects except those outlined in appendix III.
- Patients must have an ECOG performance standard of 0,1 or 2 prior to on-study and on the day prior to treatment with IHP.
- Patients must have adequate hepatic function as evidenced by bilirubin less than 2.0 mg/dL and a PT equal to 2 seconds of the upper normal limit AST/ALT less than or equal to 10 times ULN.
- Patients must be 18 years of age or greater and must be greater than 30 kg, because of reason outlined in Section 6.2.
Key exclusion criteria (9 listed)
- Pregnant patients and nursing mothers will be excluded due to the unknown effects of melphalan on the fetus or newborn.
- Patients taking immunosuppressive drugs or on chronic anticoagulation will not be eligible.
- Patients with active systemic infections are not eligible.
- Patients with biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies will be excluded.
- Patients with a history of congestive heart failure with an LVEF less than 40% will be excluded.
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 |
|---|---|---|
| Laparotomy | 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 20 Aug 2012.
- Background: PubMed 12373596Becker JC, Terheyden P, Kampgen E, Wagner S, Neumann C, Schadendorf D, Steinmann A, Wittenberg G, Lieb W, Brocker EB. Treatment of disseminated ocular melanoma with sequential fotemustine, interferon alpha, and interleukin 2. Br J Cancer. 2002 Oct 7;87(8):840-5. doi: 10.1038/sj.bjc.6600521.
- NIH Clinical Center Detailed Web PageLink 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Laparotomy in people with Melanoma, run by National Cancer Institute (NCI) 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 7 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 20 Aug 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 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?
On the ClinicalTrials.gov record for NCT00062933, 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 20 Aug 2012.