Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
NCT ID: NCT00250796
Last Updated: 2010-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2000-09-30
2006-03-31
Brief Summary
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Secondary Aims
1. Determine the toxicity of this combination in this population.
2. Determine the survival of this patient cohort treated with the combination.
3. Determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan.
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Detailed Description
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If the patient SSR status is negative, patients will not be given subcutaneous injections of octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Thalidomide+alpha interferon
Thalidomide, alpha interferon
If the patient SSR status is negative, patients will not be given subcutaneous injections of octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.
Arm 2
Thalidomide+interferon+Octreotide
Thalidomide, interferon, Octreotide
If SSR status is positive or unknown, patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance. They will also receive injections three times a week of alpha interferon and monthly injections of octreotide (Sandostatin LAR) 30 mg into their buttocks muscle..
Interventions
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Thalidomide, alpha interferon
If the patient SSR status is negative, patients will not be given subcutaneous injections of octreotide (Sandostatin LAR) but will receive the thalidomide and alfa interferon only.
Thalidomide, interferon, Octreotide
If SSR status is positive or unknown, patients will receive oral doses of thalidomide starting at 200mg a day and increasing to 800mg at increments of 200 per week depending on tolerance. They will also receive injections three times a week of alpha interferon and monthly injections of octreotide (Sandostatin LAR) 30 mg into their buttocks muscle..
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The tumor is unresectable
3. Performance status of \< 2.0
4. \> 18 years of age
5. Informed consent to be signed by patient
6. No previous treatment with thalidomide, alpha interferon, or octreotide
7. The patient may have received previous chemotherapy either systemically or via the intra hepatic artery.
8. The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation.
9. The patient must have measurable disease.
10. If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy.
11. Bilirubin \<3 X ULN, AST/ALT\<3 X ULN, creat\<2, ANC\>1.5, Platelet\>75K
12. Patients may not have symptomatic cholelithiasis.
18 Years
ALL
No
Sponsors
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University of New Mexico
OTHER
Responsible Party
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University of New Mexico - CRTC
Principal Investigators
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Ian Rabinowitz, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Locations
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University of New Mexico
Albuquerque, New Mexico, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
Countries
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Other Identifiers
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1400C
Identifier Type: -
Identifier Source: org_study_id
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