Status:
UNKNOWN
Phase II Multicentric Study of Digoxin Per os in Classic or Endemic Kaposi' s Sarcoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Kaposi' s Sarcoma
Classic Kaposi' s Sarcoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Classic and endemic Kaposi's sarcoma (KS) are lymph angio proliferations associated with human herpes virus 8 (HHV8) which treatment is poorly codified. Chemotherapies give at best 30-60% of transient...
Eligibility Criteria
Inclusion
- Age \> 18 years \<à 80 years
- Classic or endemic histologically confirmed Kaposi's Sarcoma (KS)
- Progressive disease
- KS with more than 10 lesions or involving more than one limb segment or with involvement \>3% body surface
- KS with at least 4 lesions ≥5mm
- Patients should have at least 2 others cutaneous tumor available for repeated pharmacodynamics evaluation
- At least 4 weeks wash out for all KS specific therapies including chemotherapy and immunotherapy
- Signed informed consent
Exclusion
- Symptomatic visceral lesions
- Eastern Cooperative Oncology Group ( ECOG) performance status \> 1
- Life expectancy of ≤ 6 months
- Patients already receiving digoxin
- hepatic dysfunction defined as serum bilirubin\>25 µm/l, transaminases \> 3.0 times the upper limit of normal (ULN) (5ULN in cases of liver metastases)
- bone marrow dysfunction defined as absolute neutrophil count\<1500/mcl, platelets\<150000/mcl or hemoglobin\<8g/dL
- renal failure with creatinine clearance\< 40ml/mn
- HIV positive, active infectious hepatitis, type A, B or C
- Uncontrolled systemic infection
- Pregnant or lactating women
- Presence of any of the following on electrocardiogram (ECG): atrial arrhythmias, including atrial fibrillation and flutter with Wolff-Parkinson-White syndrome; auricular ventricular (AV) block; heart rate \< 60 beats/minute and \> 100 beats/minute; ventricular fibrillation; ventricular tachycardia; premature ventricular contractions.
- History of or current cardiac arrythmia including sinus node disease, history of AV Block, accessory AV pathway (Wolff-Parkinson-White Syndrome), history myocardial infarction, any significant valvulopathy.
- Electrolyte imbalance (hypokalemia, hypo- or hypercalcemia, hypomagnesemia)
- Severe pulmonary disease and hypoxia
- Medical conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, hypothyroidism or hyperthyroidism, which would, in the opinion of the investigator, make this protocol unreasonably hazardous.
- Major thoracic or abdominal surgery within the prior 3 weeks.
- GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- Immunosuppressive regimen should not be allowed including corticosteroids
- Use of any prohibited concomitant medications:
- the calcium channel blockers diltiazem or verapamil;
- Class I and III cardiac arrhythmic agents (such as quinidine, amiodarone);
- beta-blockers (such as atenolol, metoprolol);
- indomethacin (Indocin);
- calcium carbonate antacids (e.g., Maalox, Tums, Rolaids);
- Calcium
- omeprazole;
- antidiarrheal adsorbents (kaolin and pectin);
- antibiotics P450 inhibitors clarithromycin, erythromycin telithromycin and other P450 inhibitors./such as Ritonavir)
- Persistent Grade \>2 treatment-related toxicity from prior therapy
- History of any digoxin-related or drug induced anaphylactic reaction
- Use of any other investigational agent
- Patient without health insurance coverage
- Patient under guardianship
- Enrollment into a clinical trial within last 4 weeks
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT02212639
Start Date
September 1 2014
End Date
September 1 2019
Last Update
July 23 2018
Active Locations (1)
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1
Saint-Louis Hospital
Paris, France, 75010