Sorafenib in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

NCT00303966 | Terminated Phase 2 Results

• 6 other identifiers: NCI-2012-0268814194BUCCRC-14194BNCI-7071CDR0000462339N01CM62201
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. This phase II trial is studying how well sorafenib works in treating patients with relapsed chronic lymphocytic leukemia.

Conditions

Refractory Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate

  Objective response is defined as a complete (CR) or partial (PR) remission. Complete remission is defined as no evidence of chronic lymphocytic leukemia (CLL) in marrow with normal hematopoiesis and no palpable lymphadenopathy. Partial remission is defined as improvement in blood counts from baseline with \>50% reduction in lymph nodes on examination. These are definitions from the CLL International Working Group (IWG).

  Up to week 25

• Time to Disease Progression

  Time to disease progression will be defined as the time from treatment start until disease progression and will be evaluated using the Kaplan-Meier estimator. Those who do not progress will be censored at the time that they were last known to be progression free.

  Up to 5.5 years

• Overall Survival

  Overall survival will be defined as time from the start of treatment until death from any cause and will be evaluated using the Kaplan-Meier estimator.

  Up to 5.5 years

Secondary Outcomes (3)

• Changes in Mean Microvessel Density From Baseline to Week 25

  Baseline and week 25

• Changes in Vascular Endothelial Growth Factor (VEGF) From Baseline to Week 25

  Baseline and week 25

• Changes in Plasma Level of Interleukin-8 (IL-8) From Baseline to Week 25

  Baseline and week 25

Study Arms (1)

Treatment (sorafenib tosylate)

EXPERIMENTAL

Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: sorafenib tosylate

Interventions

sorafenib tosylate DRUG

Given orally

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Treatment (sorafenib tosylate)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) by NCI-WG immunophenotype and blood criteria
• Documentation of current or prior peripheral blood (PB) or bone marrow (BM) immunophenotype compatible with CLL
• Patients who currently do not have \> 5,000/mm³ absolute lymphocytosis are eligible if they have previously met PB lymphocytosis criteria and have a current immunophenotype documenting monoclonal B lymphocytosis morphologically and immunophenotypically compatible with CLL
• Intermediate-risk (Rai stage I or II) or high-risk (Rai stage III or IV) disease, including any of the following:
• Rai stage I disease with lymphocytosis and enlarged nodes
• Rai stage II disease with lymphocytosis plus splenomegaly and/or hepatomegaly (nodes positive or negative)
• Rai stage III disease with lymphocytosis plus anemia
• Rai stage IV disease with lymphocytosis and thrombocytopenia
• Must require treatment with active disease, experiencing disease related symptoms, or having deterioration of blood counts, meeting ≥ 1 of the following criteria:
• Presence of ≥ 1 of the following disease-related symptoms:
• Weight loss \> 10% within the past 6 months
• Extreme fatigue (i.e., ECOG performance status 2: cannot work or unable to perform usual activities)
• Fever \> 100.5°F for 2 weeks without evidence of infection
• Night sweats without evidence of infection
• Evidence of progressive marrow failure, as manifested by worsening of anemia (hemoglobin \< 10 g/dL), thrombocytopenia (platelet count \< 100,000/mm³), and/or neutropenia (neutrophil count \< 2,000/mm³)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Early termination leading to small number of subjects

Results Point of Contact

• Title: Dr. Wendy Stock
• Organization: University of Chicago

wstock@medicine.bsd.uchicago.edu

773-834-8982

Study Officials

• Wendy Stock

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: November 1, 2005
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 7, 2014
• Results First Posted: April 10, 2014

Record last verified: 2014-01

Locations

US (1)