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Refractory Chronic Lymphocytic LeukemiaPhase 2NCT00303966

Sorafenib in Treating Patients With Relapsed Chronic Lymphocytic Leukemia

A Phase 2 study testing sorafenib tosylate in people with Refractory Chronic Lymphocytic Leukemia and Stage I Chronic Lymphocytic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sorafenib tosylate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Nov 2005to May 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 61Show fewer
  • 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)
  • Massive (i.e., > 6 cm below left costal margin) or progressive splenomegaly or discomfort from splenomegaly
  • Massive nodes or clusters (i.e., > 10 cm in longest diameter), progressive adenopathy, or discomfort from lymphadenopathy
  • Deterioration of blood counts and/or progressive lymphocytosis, with an increase of ≥ 10% documented over a 2-month period OR an anticipated doubling time < 6 months
  • Relapsed disease
  • Must receive at least 1, but no more than 3, prior chemotherapy regimens with any cytotoxic agent or antibody therapy
  • No fludarabine refractory disease
  • Responded to prior fludarabine without relapse or disease progression for at least 6 months
  • Patients with a history of Coombs-positive hemolytic anemia are eligible provided recovery from treatment of hemolysis and off steroids
  • No stage 0 CLL
  • No known CNS involvement
  • Life expectancy > 6 months
  • ECOG performance status 0-2 OR Karnofsky performance status 70-100%
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelets ≥ 30,000/mm³
  • Bilirubin ≤ 2 mg/dL
  • AST/ALT ≤ 2.5 times upper limit of normal (ULN)
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min (for patients with creatinine levels above normal)
  • No currently active second malignancy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patient must use effective contraception prior to and during study participation
  • No uncontrolled hypertension, defined as blood pressure (BP) > 150/100 mm Hg on 2 different measurements at least 1 day apart with either systolic or diastolic number meeting this definition
  • Patients may later enter the study, if they have achieved stable BP (i.e., < 140/90 mm Hg) on a regimen of ≤ 2 drugs after 6-8 weeks of therapy
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situations that would limit compliance with the study requirements
  • No active infection requiring systemic antibiotics
  • No evidence of bleeding diathesis
  • No evidence of bowel perforation or obstruction risk
  • No swallowing dysfunction leading to difficulty taking the study drug
  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 2 weeks since prior antibiotic therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
  • At least 12 weeks since prior monoclonal antibody
  • Concurrent warfarin for anticoagulation allowed provided all of the following are met:
  • On a stable therapeutic dose
  • INR ≤ 3
  • No active bleeding or pathological condition that carries high-risk of bleeding
  • No prior MAPK signaling inhibitor agents or anti-angiogenesis agents
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
  • No other concurrent investigational agents

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

Other trials in United States

About this study

Official title: A Phase II Study of BAY 43-9006 in Relapsed Chronic Lymphocytic Leukemia

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the objective response rate in patients with recurrent chronic lymphocytic leukemia (CLL) treated with sorafenib.

II. Determine the toxicity in patients treated with sorafenib.

SECONDARY OBJECTIVES:

  1. Correlate bone marrow angiogenesis, CLL tumor cell expression of vascular endothelial growth factor (VEGF), VEGF receptors (flt-1, KDR, flt-4 and neuropilin-1), basic fibroblast growth factor, and plasma interleukin-8 levels with response.

OUTLINE: This is a multicenter study.

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

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Being tested
sorafenib tosylate
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sorafenib tosylateDrug

    Also called BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar

    Given orally

Study groups in NCT00303966
Study groupRoleWhat they receive
Treatment (sorafenib tosylate)ExperimentalPatients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: sorafenib tosylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to week 25

  2. 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.

    Measured: Up to 5.5 years

  3. 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.

    Measured: Up to 5.5 years

Secondary outcomes (3)

  1. Changes in Mean Microvessel Density From Baseline to Week 25

    Mean microvessel density will serve as a marker of angiogenesis (other markers includes hot spot density). Will be examined using random-effects linear models.

    Measured: Baseline and week 25

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

    Changes in VEGF levels (post-pretreatment) will be assessed. A negative value indicates a decrease with treatment.

    Measured: Baseline and week 25

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

    The change (post-pretreatment) will be calculated and tested using a paired t test. A negative value indicates a decrease with treatment.

    Measured: Baseline and week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionMay 2011
  4. Study completionMay 2011

Why it stopped: Slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303966
Sponsor's protocol ID
NCI-2012-02688
Other IDs
14194B, UCCRC-14194B, NCI-7071, CDR0000462339, N01CM62201
Status last verified
Jan 2014
First submitted
15 Mar 2006
Last updated
7 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sorafenib tosylate in people with Refractory Chronic Lymphocytic Leukemia and Stage I Chronic Lymphocytic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 61 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Up to week 25). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.

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