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Safety of Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease


Phase 1
10 Years
70 Years
Not Enrolling
Both
Sickle Cell Disease

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Trial Information

Safety of Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease


- In this research study we are looking for the highest dose of Lexiscan that can be
given safely to patients with SCD. There are 4 stages to this study. Each stage will
look for the highest dose that can be given safely in the following situations: Stage
1: Lexiscan will be given through a 12 hours infusion to adults with SCD who are not
having a pain crisis. Stage 2: Lexiscan will be given through a 24 hour infusion to
adults with SCD who are not having a pain crisis. Stage 2b: Lexiscan will be given
through a 48 hour infusion to adults with SCD who are not having a pain crisis. Stage
3: Lexiscan will be given through a 24 hour infusion to adults with SCD who are having
a pain crisis. Stage 4: Lexiscan will be given through a 24 hour infusion to children
with SCD who are having a pain crisis. Stages 1-3 are now complete and closed to
accrual. The study is now open to children ages 10-17 with SCD pain crisis (stage 4)
only.

- When participants sign the consent form, they will be told what stage they will join.

- Participants in Stages 1, 2, and 2b will be given an infusion of the study drug at the
time when they do not have a pain crisis. The infusion for Stage 1 participants will
be 12 hours long, followed by a 6-hour observation period. The infusion for Stage 2
will be 24 hours long, followed by a 6-hour observation period. The infusion for Stage
2b will be 48 hours long, followed by a 6-hour observation period.

- Participants in Stages 3 and 4 will be given one infusion of the study drug when they
are admitted to the hospital for a pain crisis. The infusion will be 24 hours long,
followed by a 6-hour observation period. During the infusion, they will receive
standard treatment for their pain crisis.

- Before the infusion the following procedures will be performed: Pulmonary function test
(optional, Stage 1 only), blood test and vital signs.

- During the infusion the following procedures will be performed: heart rate and amount
of oxygen in the blood will be monitored continuously, blood tests and blood pressure.

- During the observation period immediately following the infusion the following
procedures will be performed: heart rate and amount of oxygen in the blood will be
monitored continuously, blood tests, blood pressure and Pulmonary Function test
(optional, Stage 1 only).

Inclusion Criteria


Inclusion Criteria Stage I/II/IIb: (COMPLETE AND CLOSED TO ACCRUAL)

- Participants must have sickle cell anemia confirmed by hemoglobin analysis

- Participants must report that their pain is at baseline. Additionally, they cannot
report an increase in dose or frequency of opioid use in the last 2 weeks prior to
drug administration

- Age 21-70 years

- Participants must have the laboratory indices as outlined in the protocol

- Participants must have reliable IV access as determined by the investigator

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of the study.

Inclusion Criteria Stage III: (COMPLETE AND CLOSED TO ACCRUAL)

- Participants must have sickle cell anemia confirmed by hemoglobin analysis

- Participant is admitted to the hospital for a pain episode

- Age 21-70 years

- Participants must have the laboratory indices as outlined in the protocol

- Participants must have reliable IV access as determined by the investigator

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation

Inclusion Criteria Stage IV: (open, still accruing volunteers)

- Participants must have sickle cell disease confirmed by hemoglobin analysis

- Participant is admitted to the hospital for a pain episode

- Ages of assent (10 to 17 years at DFCI, but different depending on institution)

- Participants must have the laboratory indices as outlined in the protocol

- Participants must have reliable IV access as determined by the investigator

- Participants and parents must have the ability to understand and the willingness to
sign a written informed consent and assent document

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation

Exclusion Criteria Stage I/II/IIb: (COMPLETE AND CLOSED TO ACCRUAL)

- Participants with a current physician diagnosis of asthma (within last 12 months),
require continuous supplemental oxygen, or predicted or current use of some asthma
medications.

- Participants with second- or third-degree AV block or sinus node dysfunction

- Have a history of bleeding diathesis

- Have a history of clinically overt stroke

- Have a history of severe hypertension not adequately controlled with
anti-hypertensive medications

- Participants who are receiving chronic anti-coagulation or anti-platelet therapy

- Participants with a history of metastatic cancer

- Participants who have had a hospitalization or emergency room visit for any reason in
the past 2 weeks

- Participants may not be receiving any other study agents or have received a study
agent in the past 30 days

- Uncontrolled intercurrent illness

- Pregnant or breastfeeding women

- Participants with HIV

- Participants who have previously enrolled and received the investigational agent as
part of this study

- Participants who are taking medications that may interact with the investigational
agent

Exclusion Criteria Stage III: (COMPLETE AND CLOSED TO ACCRUAL)

- Participants with a current physician diagnosis of asthma (within last 12 months),
require continuous supplemental oxygen, or predicted or current use of some asthma
medications.

- Participants with second- or third-degree AV block or sinus node dysfunction

- Have a history of bleeding diathesis

- Have a history of clinically overt stroke

- Have a history of severe hypertension not adequately controlled with
anti-hypertensive medications

- Participants who are receiving chronic anti-coagulation or anti-platelet therapy

- Participants with a history of metastatic cancer

- Participants may not be receiving any other study agents or have received a study
agent in the past 30 days

Exclusion Criteria Stage IV: (open, still accruing volunteers)

- Participants with a current physician diagnosis of asthma (within last 12 months),
require continuous supplemental oxygen, or predicted or current use of some asthma
medications.

- Participants with second- or third-degree AV block or sinus node dysfunction

- Have a history of bleeding diathesis

- Have a history of clinically overt stroke

- Have a history of hypertension not adequately controlled with anti-hypertensive
medications

- Participants who are receiving chronic anti-coagulation or anti-platelet therapy

- Participants with a history of metastatic cancer

- Participants may not be receiving any other study agents or have received a study
agent in the past 30 days

- Participants with HIV

- Participants who have previously enrolled and received the investigational agent as
part of this study

- Participants who are taking medications that may interact with the investigational
agent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if infusional Lexiscan is safe in individuals with SCD.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

David Nathan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

09-308

NCT ID:

NCT01085201

Start Date:

April 2010

Completion Date:

March 2013

Related Keywords:

  • Sickle Cell Disease
  • lexiscan
  • Anemia, Sickle Cell

Name

Location

Howard University HospitalWashington, District of Columbia  20060
Johns Hopkins UniversityBaltimore, Maryland  21205
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Washington UniversitySt. Louis, Missouri  63110
Childrens Hospital BostonBoston, Massachusetts  02115
Blood Center of WisconsinMilwaukee, Wisconsin