A Phase 2 interventional study of Thalidomide, alpha interferon and Thalidomide, interferon, Octreotide in Liver and Cancer, sponsored by University of New Mexico. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-07.
Sponsored by University of New Mexico · Phase 2, Interventional, and Treatment
Primary Aim Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma (cancer of the liver that can't be treated surgically).
Secondary Aims
The purpose of this study is to determine the response rate and time to progression of the combination of thalidomide, alfa interferon, and octreotide (Sandostatin LAR) in patients with unresectable hepatocellular carcinoma. If patients are eligible for and agree to take part in the study, they will be assigned to one of two treatment arms depending on SSR status. 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..
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 12 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
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Exclusion Criteria:
Thalidomide+alpha interferon
Drug: Thalidomide, alpha interferon
Thalidomide+interferon+Octreotide
Drug: Thalidomide, interferon, Octreotide
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.
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..
Also known as: Sandostatin LAR
Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma.
Time frame: Disease progression and toxicity
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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University of New Mexico