Lenalidomide for Advanced Hepatocellular Cancer:A Phase II Trial

NCT00717756 | Completed Phase 2 Results DMC

• 3 other identifiers: BrUOG-HC-212Celgene # RV-HCC-PI- 0159celgene
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 3

Brief Summary

This study will determine whether lenalidomide has activity in patients with advanced liver cancer that have had growth of their cancer after sorafenib.

Conditions

Liver Cancer

Keywords

liver cancer, second line

Outcome Measures

Primary Outcomes (1)

• Response Rate by Recist Criteria

  radiographic response defined as partial response defined by RECIST:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD It is noted that while on average the time frame for scans was 4 months, there were two patients who at 32 and 36 months had not progressed.

  on average about every 2 months until progression, on average about 4 months.

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Drug: lenalidomide

Interventions

lenalidomide DRUG

25 mg po qd x 21 days then 1 week off equals one cycle

Also known as: revlimid

Lenalidomide

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed HCC or triple phase CT consistent with HCC in a patient with known cirrhosis and AFP \> 200 ng/ml.
• Disease not amenable to curative surgical resection
• Patients must have been previously treated with sorafenib. Patients who are unable to receive sorafenib due to financial reasons are also eligible.
• All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
• No previous thalidomide.
• Patients must have radiologically assessable tumor.
• ECOG performance status of 0-2 at study entry.
• Understand and voluntarily sign an informed consent form.
• Age \>18 years at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Laboratory test results within these ranges:
• Absolute neutrophil count \> 1000/mm3
• Platelet count \> 60,000/mm3
• Serum creatinine \> 2.0 mg/dL
• Total bilirubin \> 4 mg/dL

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments.
• Known positive for HIV. (The effect of immune modulation of lenalidomide on patients who are HIV positive is unknown).

Sponsors & Collaborators

• Brown University: lead
• Memorial Hospital of Rhode Island: collaborator
• Roger Williams Medical Center: collaborator

Study Sites (3)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Memorial Hospital of Rhode island

Pawtucket, Rhode Island, 02860, United States

Location

Lifespan Hospitals

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Safran H, Charpentier KP, Kaubisch A, Mantripragada K, Dubel G, Perez K, Faricy-Anderson K, Miner T, Eng Y, Victor J, Plette A, Espat J, Bakalarski P, Wingate P, Berz D, Luppe D, Martel D, Rosati K, Aparo S. Lenalidomide for second-line treatment of advanced hepatocellular cancer: a Brown University oncology group phase II study. Am J Clin Oncol. 2015 Feb;38(1):1-4. doi: 10.1097/COC.0b013e3182868c66.

  PMID: 23648434 RESULT

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Howard Safran, MD
• Organization: BrUOG

Hsafran@lifespan.org

4018633000

Study Officials

• Howard Safran, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 17, 2020
• Results First Posted: April 3, 2014

Record last verified: 2020-02

Locations

US (3)