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INtraoperative photoDYnamic Therapy of GliOblastoma (INDYGO)

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ClinicalTrials.gov Identifier: NCT03048240
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
The study pilot evaluate the feasibility of a "5-ALA- PpIX (protoporhyrin IX) mediated per-PDT protocol" in patients with glioblastoma accessible for complete surgical removal of contrast. This treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol Stupp

Condition or disease Intervention/treatment Phase
Glioblastoma Device: "perPDT" Drug: GLIOLAN Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: "perPDT"
Single arm : per-operative PhotoDynamic Therapy (perPDT) during the surgery of Glioblastoma excision.
Device: "perPDT"

The protocol requires the realization of specific procedures in addition to the usual care.

The per-operative photodynamic therapy ("perPDT") added to surgery for glioblastoma excision. The patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery + lighting of the tumor bed by a light source (laser) at the end of resection (Prolonged surgery of 45 minutes).


Drug: GLIOLAN
patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery




Primary Outcome Measures :
  1. Number of Patients having the full "PerPDT" treatment with unacceptable and unexpected toxicities (grade ≥ 3) graded According to NCI CTC Version 4.0 [ Time Frame: From the intake of Gliolan (5-Ala) until 1 month post "perPDT" ]

    In particular, the following complications will be investigated: severe infection, new neurological deficit responsible for severe disability, status epilepticus, deaths during the postoperative period.

    Target: At least 6/10 patients who benefited of complete "PerPDT" and without unacceptable and unexpected toxicities



Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From the Date of diagnosis of glioblastoma until the date of Relapse defined, assessed up to 24 months ]
    Determined according to international RANO criteria

  2. Overall Survival (OS) [ Time Frame: From the date of Diagnosis of glioblastoma until the date of death, assessed up to 24 months ]
    Determined according to international RANO criteria

  3. Response to treatment [ Time Frame: From the date of perPDT until relapse/death, assessed up to 24 months ]
    Evaluated by MRI every 3 months

  4. Incidence of "per PDT" treatment-emergent Adverse Events [ Time Frame: From the beginning of treatment with perPDT up to relapsing/death, assessed up to 24 months ]
    Collection of all Adverse events (AEs and SAEs) (according to NCI-CTC V4.0) and reviewing by an Independent Safety Monitoring Board.

  5. Quality of Life Questionnaire -C30 ( QLQ-C30) [ Time Frame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months ]
    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.

  6. Quality of Life Questionnaire - Brain Cancer Module (QLQ-BN20) [ Time Frame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months ]
    Measuring the health-related quality of life in patients with brain cancer


Other Outcome Measures:
  1. Analyze of Peripheral Blood Mononuclear Cells [ Time Frame: Every 3 months from the signature of Consent form until relapse/death, assessed up to 24 months ]


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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. Patient male or female ≥18 years
  2. General status (WHO) of Performance status 0, 1 or 2
  3. Probable glioblastoma according to clinical and radiological criteria,
  4. whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
  5. Decision to treat the patient as part of the Clinical trial also taken in neuro-oncology RCP ("Multidisciplinary consultation meeting")
  6. Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
  7. Clinical neuro-oncological monitoring and long-term MRI scheduled at the hospital CHRU of Lille, center of reference of the region
  8. Patient able to understand and sign voluntarily Informed consent
  9. Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
  10. Women of child-bearing potential should benefit of an effective contraception
  11. For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA
  12. Patient assigned to an heath insurance

Exclusion Criteria:

  1. Contraindications to 5-ALA (Gliolan®) and to per-operative PhotoDynamic Therapy "perPDT":
  2. Contraindications to 5-ALA

    • Porphyria
    • Taking photosensitizer treatment
    • Severe renal or hepatic impairment
    • Bilirubin> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)> 2.5 x Maximum. rates
    • Creatinine clearance <30 mL / min;
    • Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
  3. Contraindications to surgery
  4. Contraindications to magnetic resonance imaging (MRI)
  5. Treatment with an experimental drug within 30 Days prior to the start of the study
  6. Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
  7. Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
  8. Pregnant or nursing women
  9. Refusal to participate or sign the consent of the study
  10. Soy allergy

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): NCT03048240


Contacts
Contact: Nicolas Reyns, MD,PhD +33320446721 nicolas.reyns@chru-lille.fr
Contact: Maximilien Vermandel, MD +33320446721 maximilien.vermandel@chru-lille.fr

Locations
France
Hôpital Roger Salengro, CHRU Recruiting
Lille, France
Principal Investigator: Nicolas Reyns, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Nicolas Reyns, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03048240     History of Changes
Other Study ID Numbers: 2016_06
2016-002706-39 ( EudraCT Number )
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Glioblastoma

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue