Liver CancerPhase 2NCT00006006
Thalidomide Plus Interferon Alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
A Phase 2 study testing recombinant interferon alfa and thalidomide in people with Liver Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating patients who have progressive liver cancer that cannot be surgically removed. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of the cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- recombinant interferon alfa and thalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2000to Mar 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
DISEASE CHARACTERISTICS:
- Histologically confirmed hepatocellular carcinoma OR
- Diagnosis of hepatocellular carcinoma based on characteristic mass and alpha-fetoprotein greater than 500 in the setting of known cirrhosis or chronic hepatitis B or C
- Measurable disease
- At least 20 mm in one dimension
- Not amenable to curative surgical resection
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Hematopoietic:
- Absolute neutrophil count greater than 1,200/mm^3
- Hemoglobin at least 8.0 mg/dL
- Platelet count at least 25,000/mm^3
Hepatic:
- Bilirubin no greater than 5 mg/dL
- Liver function tests no greater than 5 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Regardless of fertility status:
- All women (unless they have undergone hysterectomy or have been amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly active method of contraception AND 1 additional effective method of contraception at least 4 weeks before, during, and for at least 4 weeks after study
- All men (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study
- No other medical condition that would preclude study
- No other prior malignancy in past 5 years except curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No more than 1 prior biologic therapy regimen
- No prior interferon or thalidomide for hepatocellular cancer
Chemotherapy:
- No more than 1 prior chemotherapy regimen
Other:
- No concurrent barbiturates or alcohol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression
Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating patients who have progressive liver cancer that cannot be surgically removed. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of the cancer cells. Combining thalidomide and interferon alfa may kill more tumor cells.
Read the detailed description
OBJECTIVES:
- Determine the feasibility and activity of thalidomide in patients with unresectable hepatocellular carcinoma.
II. Evaluate the toxicity of thalidomide in these patients. III. Assess the use of interferon alfa in patients who develop disease progression while being treated with thalidomide.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily. Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity.
- Conditions
- Liver Cancer
- Being tested
- recombinant interferon alfa, thalidomide
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant interferon alfaBiological
thalidomideDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral thalidomide once daily. Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity. Receives: Biological: recombinant interferon alfa; Drug: thalidomide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 2000
- Primary completionMar 2005
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 Liver CancerStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew D. Volm, MD, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006006
- Sponsor's protocol ID
- NCI-2012-02347
- Other IDs
- NYU-9938, NCI-101, CDR0000068014
- Status last verified
- Sep 2003
- First submitted
- 5 Jul 2000
- Last updated
- 11 Feb 2013
- Results posted
- No
Publications
Schwartz JD, Sung M, Schwartz M, Lehrer D, Mandeli J, Liebes L, Goldenberg A, Volm M. Thalidomide in advanced hepatocellular carcinoma with optional low-dose interferon-alpha2a upon progression. Oncologist. 2005 Oct;10(9):718-27. doi: 10.1634/theoncologist.10-9-718.
PubMed 16249352
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalidomide for Unresectable Hepatocellular Cancer With Optional Interferon Alpha-2a Upon Disease Progression
- ClinicalTrials.gov ID
- NCT00006006
- Acronym / sponsor ID
- NCI-2012-02347
- Conditions
- Liver Cancer
- Keywords
- localized unresectable adult primary liver cancer, advanced adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2000
- Primary completion
- Mar 2005 (actual)
- First posted
- 27 Jan 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.
Phase II trial to study the effectiveness of thalidomide plus interferon alfa in treating patients who have progressive liver cancer that cannot be surgically removed. Thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. Interferon alfa may interfere with the growth of the cancer cells. Combining thalidomide and interferon alfa may kill more tumor cells.
Detailed description
OBJECTIVES:
- Determine the feasibility and activity of thalidomide in patients with unresectable hepatocellular carcinoma.
II. Evaluate the toxicity of thalidomide in these patients. III. Assess the use of interferon alfa in patients who develop disease progression while being treated with thalidomide.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily. Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: recombinant interferon alfa, Drug: thalidomidePatients receive oral thalidomide once daily. Patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. Treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| recombinant interferon alfa | Biological | Arm I |
| thalidomide | Drug | Arm I |
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 11 Feb 2013.
- Results publication: PubMed 16249352Schwartz JD, Sung M, Schwartz M, Lehrer D, Mandeli J, Liebes L, Goldenberg A, Volm M. Thalidomide in advanced hepatocellular carcinoma with optional low-dose interferon-alpha2a upon progression. Oncologist. 2005 Oct;10(9):718-27. doi: 10.1634/theoncologist.10-9-718.
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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.
Matthew D. Volm, MD study chair
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant interferon alfa and thalidomide in people with Liver Cancer, run by National Cancer Institute (NCI) at 2 sites 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?
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 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 NCT00006006, 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 11 Feb 2013.