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    Summary
    EudraCT Number:2015-000167-14
    Sponsor's Protocol Code Number:105-15-201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-000167-14
    A.3Full title of the trial
    HEAT-ACTIVATED TARGET THERAPY RADIOTHERAPY + HYPERTHERMIA + LYSO THERMOSENSITIVE LIPOSOMAL DOXORUBICIN) OF LOCALREGIONAL RELAPSE IN BREAST CANCER PATIENTS
    Terapia target attivata dal calore (radioterapia + ipertermia + doxorubicina liposomiale liso-termosensibile) della recidiva locoregionale in pazienti affette da carcinoma mammario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the safety and efficacy for patients with localregional relapse in breast cancer scheduled to be treated with radiotherapy, hyperthermia and Lyso-Thermosenstive Liposomal Doxorubicin
    Uno studio clinico per valutare la sicurezza e l'efficacia per i pazienti con recidiva locale regionale nel cancro della mammella in programma di essere trattati con la radioterapia, ipertermia e liso-Thermosenstive doxorubicina liposomiale
    A.3.2Name or abbreviated title of the trial where available
    HEAT-ACTIVATED TARGET THERAPY (RADIOTHERAPY + HYPERTHERMIA + LYSO-THERMOSENSITIVE LIPOSOMAL DOXORUBI
    Terapia target attivata dal calore (radioterapia + ipertermia + doxorubicina liposomiale liso-termos
    A.4.1Sponsor's protocol code number105-15-201
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCELSION CORPORATION
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelsion Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelsion Corporation
    B.5.2Functional name of contact pointAss. Director, Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address997 Lenox Dr., Suite 100
    B.5.3.2Town/ cityLawrenceville, NJ
    B.5.3.3Post code08648
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016098969100
    B.5.5Fax number0016098962200
    B.5.6E-mailregulatory@celsion.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameThermoDox(R)
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICINA CLORIDRATO
    D.3.9.1CAS number 25316-40-9
    D.3.9.2Current sponsor code105-15-201
    D.3.9.3Other descriptive namedoxorubicin hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Local-Regional Relapse in Breast Cancer
    recidiva locoregionale in pazienti affette da carcinoma mammario
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Cancro al seno
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the safety and tolerability of the combination of ThermoDox + Hyperthermia + Radiotherapy among patients with locoregional
    recurrent breast cancer.
    - To evaluate loco-regional breast tumor control in patient who underwent ThermoDox + Hyperthermia + Radiotherapy as measured by target lesion clinical response rate combining RECIST criteria with digital photography to gauge response.
    ¿ Valutare la sicurezza e la tollerabilit¿ dell'associazione di ThermoDox + ipertermia + radioterapia in pazienti con carcinoma mammario LRR.
    ¿ Valutare il controllo del tumore al seno locoregionale in pazienti sottoposte a ThermoDox + ipertermia + radioterapia, misurato mediante il tasso di risposta clinica della lesione target combinando i criteri RECIST con la fotografia digitale per valutare la risposta.
    E.2.2Secondary objectives of the trial
    (partial response) and SD (stable disease) following treatment with ThermoDox + Hyperthermia + Radiotherapy up to 12 months among patients with loco-regional breast cancer.
    - To assess Patient Reported Quality of Life using the FACT-B and Brief Pain Inventory (BPI) following treatment with ThermoDox + Hyperthermia + Radiotherapy among patients with loco-regional breast cancer.
    ¿ Valutare la durata del controllo locale [CR (risposta completa), PR (risposta parziale) e SD (malattia stabile)] dopo il trattamento con ThermoDox + ipertermia + radioterapia, fino a 12 mesi, tra le pazienti con carcinoma mammario LRR.
    ¿ Valutare la qualit¿ della vita riferita dalle pazienti mediante il questionario FACT-B e Brief Pain Inventory (BPI) dopo il trattamento con ThermoDox + ipertermia + radioterapia, tra le pazienti con carcinoma mammario LRR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically documented recurrent denocarcinoma of the breast with a recurrence on the chest wall or its overlying skin:
    •Ulcerative chest wall disease defined as non-healing wounds consistent with cancer,
    •Inflammatory breast carcinoma,
    •Breast carcinoma not resected for medical reasons.
    2.Tumor thickness, must be clinically indicated for hyperthermia therapy, as measured by clinical exam or radiological imaging studies (CT or MRI). The target local tumor lesion(s) must be able to be covered within two hyperthermia fields of treatment.
    3.LRR Disease progression despite other available standard treatment options based on what is clinically indicated according to the investigator's clinical and medical judgment, including: one or more radiation treatment(s) to the chest wall.
    4.Patients with stable distant bone metastasis; concomitant treatment with Zoledronic acid and Denosumab is allowed.
    5.Non-pregnant female at least 18 years of age. If subject is of childbearing age, must have a negative serum pregnancy test at baseline and must agree to practice an acceptable form of birth control while on the study.
    6.Provide written informed consent and willing to comply with protocol requirements.
    1. Adenocarcinoma della mammella recidivato, documentato istologicamente, con recidiva sulla parete toracica o cute sovrastante:
    • Malattia ulcerativa della parete toracica, definita come lesioni croniche compatibili con il cancro.
    • Carcinoma mammario infiammatorio.
    • Carcinoma mammario non resecato per ragioni mediche.
    2. Lo spessore tumorale, misurato mediante esame clinico o studi di imaging radiologico (TC o RM), deve essere clinicamente indicato per la terapia con ipertermia. La lesione o lesioni tumorali locali target devono poter essere coperte con due campi di trattamento con ipertermia.
    3. Progressione della malattia LRR nonostante altre opzioni di trattamento standard disponibili, sulla base di quanto clinicamente indicato a giudizio clinico e medico dello sperimentatore, inclusi: una o più radioterapie alla parete toracica.
    4. Pazienti con metastasi ossea distante stabile; il trattamento concomitante con acido zoledronico e denosumab è consentito.
    5. Donne non in gravidanza di almeno 18 anni di età. Se il soggetto è in età fertile, deve risultare negativo al test di gravidanza sul siero al basale e deve acconsentire a utilizzare un metodo contraccettivo accettabile durante lo studio.
    6. Fornire il consenso informato scritto ed essere disposte a rispettare i requisiti del protocollo.
    E.4Principal exclusion criteria
    1.No concomitant cytotoxic antineoplastic therapy is allowed. Prior chemotherapy should not be administered within 5 half-lives or 28 days whichever is shorter.
    2.Prior confirmed allergic reaction (including moderate rash, dyspnea, wheezing, urticaria or other symptoms) attributed to the administration
    of either anthracyclines or other liposomally encapsulated drugs that required discontinuation of prior therapy.
    3.Patients who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy.
    4.Previous treatment with anthracyclines exceeding the following dosages: free doxorubicin (i.e. non- liposomal) and/or liposomal doxorubicin > 300 mg/m2 or epirubicin free > 540 mg/m2.
    5.Previous (required active treatment within 5 years) or concomitant malignancy except basal cell cancer, in situ carcinoma of the cervix, or contralateral breast cancer. Subjects with a prior contralateral breast malignancy can be included if they did not receive any chemotherapy.
    6.Baseline laboratories (to establish eligibility):
    •ANC Granulocytes < 1,500/ microliter
    •Platelets < 75,000/ microliter
    •Hemoglobin < 9 gm/dL
    •Total Bilirubin > 2 mg/dL
    •ALT and AST > 2.5 X upper limit of normal
    •Creatinine > 1.5 X upper limit of normal
    7.ECOG/Zubrod Performance Status > 2.
    8.MUGA/Echocardiogram Left Ventricular Ejection Fraction < 50%.
    9.History of:
    •Acute coronary syndrome
    •Cerebral vascular accident
    •Abnormal cardiac stress testing within last 6 months
    •Symptomatic coronary artery disease
    •Uncontrolled hypertension or cardiomyopathy
    •Cardiac valvular surgery or open heart surgery
    •Known structural heart disease
    10.Conditions which may interfere with hyperthermia portion of the trial such as: functioning cardiac pacemaker; metal plates, rods or prosthesis
    of the chest wall, breast reconstruction with implants, severe numbness and/or tingling of the chest wall or breast, skin grafts and/or flaps on
    the breast/chest wall.
    11. Serious active infection requiring long-term antibiotic treatment.
    12. Has received any external radiation therapy within 60 days prior to study enrollment.
    13. Patients with parenchymal and known brain metastases; if metastasis is operated or irradiated the patient can be included in the study
    1. Non sono consentite terapie antineoplastiche citotossiche concomitanti. La precedente chemioterapia non deve essere somministrata entro 5 emivite o 28 giorni, a seconda del termine più breve.
    2. Reazione allergica pregressa confermata (inclusi rash moderato, dispnea, sibilo respiratorio, orticaria o altri sintomi), attribuita alla somministrazione di antracicline o altri farmaci incapsulati in liposomi, che ha richiesto l'interruzione della terapia precedente.
    3. Pazienti che hanno ricevuto in precedenza ipertermia in associazione a radioterapia o chemioterapia.
    4. Precedente trattamento con antracicline a dosi superiori a: doxorubicina libera (ossia non liposomiale) e/o doxorubicina liposomiale = 300 mg/m2, epirubicina libera > 540 mg/m2.
    5. Tumore maligno pregresso (che ha richiesto trattamento attivo nell'arco di 5 anni) o concomitante, eccetto carcinoma basocellulare, carcinoma della cervice in situ o cancro nella mammella controlaterale. I soggetti con precedente tumore maligno nella mammella controlaterale possono essere inclusi se non hanno ricevuto alcuna chemioterapia.
    6. Valori di laboratorio al basale (per stabilire l’eleggibilità): · Granulociti ......< 1.500/microlitro · Piastrine .......... < 75.000/microlitro · Emoglobina ... < 9 mg/dl Bilirubina totale ... > 2 mg/dl ALT e AST ...> 2,5 volte il limite superiore della norma Creatinina ......... > 1,5 volte il limite superiore della norma.
    7. Performance status ECOG/Zubrod > 2.
    8. Frazione di eiezione ventricolare sinistra con MUGA/ecocardiogramma < 50%.
    9. Anamnesi positiva per: sindrome coronarica acuta, accidente cerebrovascolare, anomalie al test da sforzo cardiaco negli ultimi 6 mesi, coronaropatia sintomatica, ipertensione non controllata o cardiomiopatia e intervento chirurgico cardiaco valvolare o a cuore aperto.
    10. Condizioni cliniche che possono interferire con la parte dello studio che prevede ipertermia, quali: pacemaker cardiaco in funzione; placche, chiodi o protesi in metallo della parete toracica, ricostruzione del seno con impianti protesici, severo intorpidimento e/o formicolio della parete toracica o del seno, innesti e/o lembi cutanei sul seno/sulla parete toracica.
    11. Infezione attiva grave che richiede il trattamento con antibiotici a lungo termine.
    12. Radioterapia esterna nei 60 giorni precedenti l'arruolamento nello studio.
    13. Pazienti con metastasi parenchimali e cerebrali note; se la metastasi viene operata o irradiata, la paziente può essere inclusa nello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Tumor Response Evaluation for Assessing Breast and Chest Wall lesions using RECIST criteria
    Safety and Tolerability assessment with the combination of ThermoDox, hyperthermia and radiation therapy.
    Valutazione della risposta tumorale obiettiva per l'analisi delle lesioni della parete toracica e del seno, medicante criteri RECIST
    Valutazione della sicurezza e tollerabilità con la combinazione ThermoDox, Ipertermia e radioterapia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cycle 3, Cycle 5, EOT and Follow-up for up to 1 year
    From baseline through EOT
    CIclo 3, ciclo 5, alla visita di fine trattamento e follow up fino ad un anno.

    Dal basale fino alla visita di fine trattamento
    E.5.2Secondary end point(s)
    Duration of local control [CR (complete response), PR (partial response) and SD (stable disease) following treatment with ThermoDox +
    Hyperthermia + Radiotherapy up to 12 months among patients with LRR breast cancer.

    Assess Patient Reported Quality of Life
    Valutare la durata del controllo locole [RC (risposta completa), RP (risposta parziale) e MS (malattia stabile)] dopo il trattamento co TermoDox+Ipertermia+Radioterapia, fino a 12 mesi tra le oazienti con carcinoma mammario con recidiva locoregionale
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline to Follow-Up
    From Baseline to EOT
    Dal basale fino al follow-up
    Dal basale fino alla visita di fine trattamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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