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

Primary Purpose

Liver, Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide, alpha interferon
Thalidomide, interferon, Octreotide
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver focused on measuring Phase II, Hepatocellular carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein >500 ng/ ml The tumor is unresectable Performance status of < 2.0 > 18 years of age Informed consent to be signed by patient No previous treatment with thalidomide, alpha interferon, or octreotide The patient may have received previous chemotherapy either systemically or via the intra hepatic artery. The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation. The patient must have measurable disease. If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy. Bilirubin <3 X ULN, AST/ALT<3 X ULN, creat<2, ANC>1.5, Platelet>75K Patients may not have symptomatic cholelithiasis. Exclusion Criteria:

Sites / Locations

  • University of New Mexico
  • New Mexico Cancer Care Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Thalidomide+alpha interferon

Thalidomide+interferon+Octreotide

Outcomes

Primary Outcome Measures

Determine the response rate and time to progression of the combination of thalidomide, interferon, and octreotide in patients with unresectable hepatocellular carcinoma.

Secondary Outcome Measures

Full Information

First Posted
November 4, 2005
Last Updated
January 6, 2010
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT00250796
Brief Title
Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
Official Title
Trial of Thalidomide, a- Interferon +/- Octreotide in Patients With Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of New Mexico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Determine the toxicity of this combination in this population. Determine the survival of this patient cohort treated with the combination. Determine the percent of patients with hepatocellular carcinoma who have a positive octreotide scan.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver, Cancer
Keywords
Phase II, Hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Thalidomide+alpha interferon
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Thalidomide+interferon+Octreotide
Intervention Type
Drug
Intervention Name(s)
Thalidomide, alpha interferon
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Thalidomide, interferon, Octreotide
Other Intervention Name(s)
Sandostatin LAR
Intervention Description
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..
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven diagnosis of hepatocellular or radiographic evidence of a hepatic lesion consistent with hepatoma and an alpha feto protein >500 ng/ ml The tumor is unresectable Performance status of < 2.0 > 18 years of age Informed consent to be signed by patient No previous treatment with thalidomide, alpha interferon, or octreotide The patient may have received previous chemotherapy either systemically or via the intra hepatic artery. The patient may have had previous surgery or regional therapy such as intra tumoral injection of alcohol, cryosurgery, or radiofrequency ablation. The patient must have measurable disease. If female, the patient must have a negative pregnancy test and agree not to fall pregnant during this therapy. Bilirubin <3 X ULN, AST/ALT<3 X ULN, creat<2, ANC>1.5, Platelet>75K Patients may not have symptomatic cholelithiasis. Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Rabinowitz, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
New Mexico Cancer Care Associates
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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