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Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT00250796
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : January 7, 2010
Sponsor:
Information provided by:
University of New Mexico

Brief Summary:

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

  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.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: Thalidomide, alpha interferon Drug: Thalidomide, interferon, Octreotide Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
Study Start Date : September 2000
Actual Primary Completion Date : January 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm 1
Thalidomide+alpha interferon
Drug: 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.
Experimental: Arm 2
Thalidomide+interferon+Octreotide
Drug: 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 Name: Sandostatin LAR



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein >500 ng/ ml
  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.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250796


Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Ian Rabinowitz, MD University of New Mexico

Responsible Party: Ian Rabinowitz, MD; Principal Investigator, University of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00250796     History of Changes
Other Study ID Numbers: 1400C
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: December 2009

Keywords provided by University of New Mexico:
Phase II
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Interferons
Thalidomide
Octreotide
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Gastrointestinal Agents
Antineoplastic Agents, Hormonal