Phase 1
N=39
Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT01085201 ↗Enrolled (actual)
39
Serious AEs
9.1%
Results posted
Mar 2014
Primary outcome: Primary: Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD. — 1; 0; 0; 0 number of DLT
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Lexiscan (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD. |
1; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Activated iNKT Cells and/or Activation Markers on iNKT Cells in Individuals With SCD. |
-3; -48 | — |
| SECONDARY Pain Levels During a Vaso-occlusive Event in Children and Adults With SCD. |
5.8; 7.8 | — |
Summary
Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different type of protein that carries oxygen in their blood (hemoglobin) then people without SCD. This different type of hemoglobin makes the red blood cells change into a crescent shape under certain conditions. Sickle-shaped cells are a problem because they often get stuck in blood vessels blocking the flow of blood, and cause inflammation and injury to the important areas in the body. Lexiscan is drug that may prevent this inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast infusion during a heart stress test in people who are unable to exercise enough to put stress on their heart by making it beat faster. Lexiscan has never been studied in patients with SCD and has never been given as a long infusion.
Eligibility 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 pred
Data sourced from ClinicalTrials.gov (NCT01085201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.