Carcinoma, HepatocellularNCT00701168
Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer
A study testing yttrium Y 90 microspheres (Therasphere®) in people with Carcinoma, Hepatocellular and Neoplasm Metastasis, run by Leo W. Jenkins Cancer Center at 1 site in United States.
Trial summary
The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Neoplasm Metastasis
- What is being tested?
- yttrium Y 90 microspheres (Therasphere®)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 19 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
- The cancer must be unresectable with limited established treatment options
- ECOG Performance Status Score 0-2
- Age 19 years or older
- Able to comprehend and provide written informed consent
Who cannot join
- Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
- Absolute granulocyte count ≤ 1,500/ul
- Platelet count ≤ 75,000/ul
- Serum creatinine > 2.0 mg/dl
- Serum bilirubin ≥ 2.0 mg/dl
- Any of the following contraindications to angiography and selective visceral catheterization:
Show all 17Show fewer
- History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine
- Bleeding, diathesis, not correctable by usual forms of therapy
- Severe peripheral vascular disease that would preclude catheterization
- Substantial venous shunt away from the liver
- Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments
- Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow
- Significant extrahepatic disease representing an imminent life- threatening situation outcome
- Severe liver dysfunction or pulmonary insufficiency
- Active uncontrolled infection
- Significant underlying medical or psychiatric illness
- Pregnant women may not participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Leo W Jenkins Cancer Center at East Carolina University School of Medicine
Greenville, North Carolina, 27834
About this study
Official title: A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006
The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.
- Conditions
- Carcinoma, Hepatocellular, Neoplasm Metastasis
- Being tested
- yttrium Y 90 microspheres (Therasphere®)
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yttrium Y 90 microspheres (Therasphere®)Device
This is a local therapy for unresectable liver tumors with limited treatment options. It may be repeated under special circumstances.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (65)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Leo W. Jenkins Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Russo, MD, Principal investigator, East Carolina University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701168
- Sponsor's protocol ID
- LJCC 07-04
- Status last verified
- Aug 2017
- First submitted
- 17 Jun 2008
- Last updated
- 23 Aug 2017
- Results posted
- No
Publications
Houle S, Yip TK, Shepherd FA, Rotstein LE, Sniderman KW, Theis E, Cawthorn RH, Richmond-Cox K. Hepatocellular carcinoma: pilot trial of treatment with Y-90 microspheres. Radiology. 1989 Sep;172(3):857-60. doi: 10.1148/radiology.172.3.2549567.
PubMed 2549567Andrews JC, Walker-Andrews SC, Juni JE, Warber S, Ensminger WD. Modulation of liver tumor blood flow with hepatic arterial epinephrine: a SPECT study. Radiology. 1989 Dec;173(3):645-7. doi: 10.1148/radiology.173.3.2813766.
PubMed 2813766Wollner I, Knutsen C, Smith P, Prieskorn D, Chrisp C, Andrews J, Juni J, Warber S, Klevering J, Crudup J, et al. Effects of hepatic arterial yttrium 90 glass microspheres in dogs. Cancer. 1988 Apr 1;61(7):1336-44. doi: 10.1002/1097-0142(19880401)61:73.0.co;2-k.
PubMed 3345490Ziessman HA, Thrall JH, Gyves JW, Ensminger WD, Niederhuber JE, Tuscan M, Walker S. Quantitative hepatic arterial perfusion scintigraphy and starch microspheres in cancer chemotherapy. J Nucl Med. 1983 Oct;24(10):871-5.
PubMed 6225839Nakamura H, Tanaka M, Oi H. Hepatic embolization from the common hepatic artery using balloon occlusion technique. AJR Am J Roentgenol. 1985 Jul;145(1):115-6. doi: 10.2214/ajr.145.1.115. No abstract available.
PubMed 3873830Wellwood JM, Cady B, Oberfield RA. Treatment of primary liver cancer: response to regional chemotherapy. Clin Oncol. 1979 Mar;5(1):25-31. No abstract available.
PubMed 217565Reed ML, Vaitkevicius VK, Al-Sarraf M, Vaughn CB, Singhakowinta A, Sexon-Porte M, Izbicki R, Baker L, Straatsma GW. The practicality of chronic hepatic artery infusion therapy of primary and metastatic hepatic malignancies: ten-year results of 124 patients in a prospective protocol. Cancer. 1981 Jan 15;47(2):402-9. doi: 10.1002/1097-0142(19810115)47:23.0.co;2-b.
PubMed 6257376Dusheiko GM, Hobbs KE, Dick R, Burroughs AK. Treatment of small hepatocellular carcinomas. Lancet. 1992 Aug 1;340(8814):285-8. doi: 10.1016/0140-6736(92)92367-o.
PubMed 1353202Kirk S, Blumgart R, Craig B, Rosen A, Terblanche J, Spence RA. Irresectable hepatoma treated by intrahepatic iodized oil doxorubicin hydrochloride: initial results. Surgery. 1991 Jun;109(6):694-7.
PubMed 1645890Ravoet C, Bleiberg H, Gerard B. Non-surgical treatment of hepatocarcinoma. J Surg Oncol Suppl. 1993;3:104-11. doi: 10.1002/jso.2930530529.
PubMed 8389154Audisio RA, Doci R, Mazzaferro V, Bellegotti L, Tommasini M, Montalto F, Marchiano A, Piva A, DeFazio C, Damascelli B, et al. Hepatic arterial embolization with microencapsulated mitomycin C for unresectable hepatocellular carcinoma in cirrhosis. Cancer. 1990 Jul 15;66(2):228-36. doi: 10.1002/1097-0142(19900715)66:23.0.co;2-g.
PubMed 2164435Ichihara T, Sakamoto K, Mori K, Akagi M. Transcatheter arterial chemoembolization therapy for hepatocellular carcinoma using polylactic acid microspheres containing aclarubicin hydrochloride. Cancer Res. 1989 Aug 1;49(15):4357-62.
PubMed 2472878Stuart KE, Anand AJ, Jenkins RL. Hepatocellular carcinoma in the United States. Prognostic features, treatment outcome, and survival. Cancer. 1996 Jun 1;77(11):2217-22. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-M.
PubMed 8635087Di Bisceglie AM, Rustgi VK, Hoofnagle JH, Dusheiko GM, Lotze MT. NIH conference. Hepatocellular carcinoma. Ann Intern Med. 1988 Mar;108(3):390-401. doi: 10.7326/0003-4819-108-3-390.
PubMed 2449110Kassianides C, Kew MC. The clinical manifestations and natural history of hepatocellular carcinoma. Gastroenterol Clin North Am. 1987 Dec;16(4):553-62.
PubMed 2831150
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006
- ClinicalTrials.gov ID
- NCT00701168
- Acronym / sponsor ID
- LJCC 07-04
- Conditions
- Carcinoma, Hepatocellular, Neoplasm Metastasis
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Leo W. Jenkins Cancer CenterUniversity, hospital or other
- First posted
- 19 Jun 2008 (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.
The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.
Study design
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of primary or metastatic intrahepatic carcinoma
- The cancer must be unresectable with limited established treatment options
- ECOG Performance Status Score 0-2
- Age 19 years or older
- Able to comprehend and provide written informed consent
Key exclusion criteria (17 listed)
- Any pre-treatment laboratory findings within 15 days of treatment demonstrating:
- Absolute granulocyte count ≤ 1,500/ul
- Platelet count ≤ 75,000/ul
- Serum creatinine > 2.0 mg/dl
- Serum bilirubin ≥ 2.0 mg/dl
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 |
|---|---|---|
| yttrium Y 90 microspheres (Therasphere®)This is a local therapy for unresectable liver tumors with limited treatment options. It may be repeated under special circumstances. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Background: PubMed 2549567Houle S, Yip TK, Shepherd FA, Rotstein LE, Sniderman KW, Theis E, Cawthorn RH, Richmond-Cox K. Hepatocellular carcinoma: pilot trial of treatment with Y-90 microspheres. Radiology. 1989 Sep;172(3):857-60. doi: 10.1148/radiology.172.3.2549567.
- Background: PubMed 2813766Andrews JC, Walker-Andrews SC, Juni JE, Warber S, Ensminger WD. Modulation of liver tumor blood flow with hepatic arterial epinephrine: a SPECT study. Radiology. 1989 Dec;173(3):645-7. doi: 10.1148/radiology.173.3.2813766.
- Background: PubMed 3345490Wollner I, Knutsen C, Smith P, Prieskorn D, Chrisp C, Andrews J, Juni J, Warber S, Klevering J, Crudup J, et al. Effects of hepatic arterial yttrium 90 glass microspheres in dogs. Cancer. 1988 Apr 1;61(7):1336-44. doi: 10.1002/1097-0142(19880401)61:73.0.co;2-k.
- Background: PubMed 6225839Ziessman HA, Thrall JH, Gyves JW, Ensminger WD, Niederhuber JE, Tuscan M, Walker S. Quantitative hepatic arterial perfusion scintigraphy and starch microspheres in cancer chemotherapy. J Nucl Med. 1983 Oct;24(10):871-5.
- Background: PubMed 3873830Nakamura H, Tanaka M, Oi H. Hepatic embolization from the common hepatic artery using balloon occlusion technique. AJR Am J Roentgenol. 1985 Jul;145(1):115-6. doi: 10.2214/ajr.145.1.115. No abstract available.
- Background: PubMed 217565Wellwood JM, Cady B, Oberfield RA. Treatment of primary liver cancer: response to regional chemotherapy. Clin Oncol. 1979 Mar;5(1):25-31. No abstract available.
- Background: PubMed 6257376Reed ML, Vaitkevicius VK, Al-Sarraf M, Vaughn CB, Singhakowinta A, Sexon-Porte M, Izbicki R, Baker L, Straatsma GW. The practicality of chronic hepatic artery infusion therapy of primary and metastatic hepatic malignancies: ten-year results of 124 patients in a prospective protocol. Cancer. 1981 Jan 15;47(2):402-9. doi: 10.1002/1097-0142(19810115)47:23.0.co;2-b.
- Background: PubMed 1353202Dusheiko GM, Hobbs KE, Dick R, Burroughs AK. Treatment of small hepatocellular carcinomas. Lancet. 1992 Aug 1;340(8814):285-8. doi: 10.1016/0140-6736(92)92367-o.
- Background: PubMed 1645890Kirk S, Blumgart R, Craig B, Rosen A, Terblanche J, Spence RA. Irresectable hepatoma treated by intrahepatic iodized oil doxorubicin hydrochloride: initial results. Surgery. 1991 Jun;109(6):694-7.
- Background: PubMed 8389154Ravoet C, Bleiberg H, Gerard B. Non-surgical treatment of hepatocarcinoma. J Surg Oncol Suppl. 1993;3:104-11. doi: 10.1002/jso.2930530529.
- Background: PubMed 2164435Audisio RA, Doci R, Mazzaferro V, Bellegotti L, Tommasini M, Montalto F, Marchiano A, Piva A, DeFazio C, Damascelli B, et al. Hepatic arterial embolization with microencapsulated mitomycin C for unresectable hepatocellular carcinoma in cirrhosis. Cancer. 1990 Jul 15;66(2):228-36. doi: 10.1002/1097-0142(19900715)66:23.0.co;2-g.
- Background: PubMed 2472878Ichihara T, Sakamoto K, Mori K, Akagi M. Transcatheter arterial chemoembolization therapy for hepatocellular carcinoma using polylactic acid microspheres containing aclarubicin hydrochloride. Cancer Res. 1989 Aug 1;49(15):4357-62.
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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.
Suzanne Russo, MD principal investigator
East Carolina University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yttrium Y 90 microspheres (Therasphere®) in people with Carcinoma, Hepatocellular and Neoplasm Metastasis, run by Leo W. Jenkins Cancer Center 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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 23 Aug 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.
Are results available for this study?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00701168, which also lists 65 linked publications.
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 23 Aug 2017.