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Doxorubicin-loaded Anti-EGFR-immunoliposomes (C225-ILs-dox) in High-grade Gliomas (GBM-LIPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03603379
Recruitment Status : Completed
First Posted : July 27, 2018
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

Anti-EGFR-immunoliposomes loaded with doxorubicin (C225-ILs-dox) are given intravenously in patients with relapsed or refractory high-grade gliomas.

The pharmacokinetics of C225-ILs-dox in peripheral blood (PB), cerebro-spinal fluid (CSF) and resected tumour tissue will be assessed.


Condition or disease Intervention/treatment Phase
Glioblastoma Drug: C225-ILs-dox Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pharmacokinetic Phase 1 Study of Anti-epidermal Growth Factor Receptor (EGFR) -Immunoliposomes Loaded With Doxorubicin in Patients With Relapsed or Refractory High-grade Gliomas
Actual Study Start Date : November 16, 2018
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: C225-ILs-dox i.v.
C225-ILs-dox administered intravenously
Drug: C225-ILs-dox
C225-ILs-dox will be administered at a dose of 50 mg/m2. i.v., on day 1 of each cycle, cycle length is 28 days. In total, 4 cycles are planned to be applied.




Primary Outcome Measures :
  1. Ratio of C225-ILs-dox concentration [ Time Frame: 24 hours after first C225-ILs-dox application ]
    Ratio of C225-ILs-dox concentration in cerebro-spinal fluid over the C225-ILs-dox concentration in peripheral blood.


Secondary Outcome Measures :
  1. Tumour response according to RANO criteria on the final MRI scan [ Time Frame: At the end of 4 treatment cycle 4 (each cycle is 28 days) ]
    Tumour response according to RANO criteria; RANO criteria: divides response into four types of response based on imaging (MRI) and clinical features: complete response partial response stable disease progression

  2. Best achieved tumour response (1st or second MRI scan) during treatment phase according to RANO criteria ( [ Time Frame: between day 28 and day 104 ]
    1st or second MRI scan during treatment phase according to RANO criteria. RANO criteria: divides response into four types of response based on imaging (MRI) and clinical features: complete response partial response stable disease progression

  3. Event free survival [ Time Frame: 12 months ]
    Defined as the time between registration to progression, termination of therapy for toxicity, or death whichever occurs first.

  4. Progression free survival [ Time Frame: 12 months ]
    Defined as the time between registration to progression or death whichever occurs first

  5. Overall survival [ Time Frame: 12 months ]
    Defined as the time between registration to death due to any cause

  6. Toxicity as graded by the CTCAE Version 4.0 [ Time Frame: 12 months ]
    CTCAE grade 4 Life-threatening consequences; urgent intervention indicated; Neutrophils < 0.5 x 109/l or Platelets < 25 x 109/l; febrile neutropenia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent according to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) regulations before registration and prior to any trial specific procedures
  2. Patients with relapsed histologically proven glioblastoma ≥ 18 years of age.
  3. Patients need to have at least one line of treatment with combined radio-chemotherapy
  4. EGFR amplification. EGFR amplification will be tested by comparative genomic hybridization (CGH) method. EGFR will be considered amplified if the value is 0.15 above the average signal of chromosome 7.
  5. Evaluable disease on MRI brain scan
  6. Adequate bone marrow function: neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L
  7. Adequate hepatic function: bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST), Alanin-Aminotransferase (ALT) and alkaline phosphatase (AP) ≤ 2.5 x ULN
  8. Adequate renal function: serum creatinine ≤ 1.5 x ULN and calculated creatinine clearance > 30 mL/min, according to the formula of Cockcroft-Gault
  9. Adequate cardiac function: Left ventricular Ejection Fraction (LVEF) ≥ 50% as determined by either echocardiography (ECHO) or radionuclide angiocardiography (MUGA) in addition to pre- (brain-type natriuretic Peptide) BNP from peripheral blood
  10. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours).
  11. No contraindications for lumbar puncture
  12. Women with child-bearing potential have to use effective contraception, are not allowed to be pregnant and have to agree not to become pregnant during trial treatment and during the 6 months thereafter. A negative pregnancy test before inclusion into the trial is required for all women with child-bearing potential.

Exclusion Criteria:

  1. History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration except for adequately treated cervical carcinoma in situ and localized non-melanoma skin cancer.
  2. Lack to provide written informed consent
  3. Previous therapy with more than 240 mg/m2 of doxorubicin or more than 450 mg/m2 of epirubicin
  4. Any serious underlying medical condition (at the judgement of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes, etc.)
  5. Breastfeeding and pregnancy
  6. Participation in any investigational drug trial within 4 weeks preceding treatment start
  7. Any concomitant drugs contraindicated when administering Erbitux™ or Caelyx™ according to the Swissmedic-approved product information
  8. Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)
  9. Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603379


Locations
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Switzerland
Kantonsspital Aarau (KSA), Oncology
Aarau, Switzerland, 5001
Department of Oncology University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Heinz Laeubli, MD Dep. Oncology University Hospital Basel
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03603379    
Other Study ID Numbers: 2018-01160; me17Kasenda2
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
anti- EGFR- immunoliposomes
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue