Trial Search Results

Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas (INTELLANCE 2)

This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide versus temozolomide or lomustine alone in participants with recurrent glioblastoma multiforme.The study includes a Pediatric sub-study to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

AbbVie

Collaborator: European Organisation for Research and Treatment of Cancer - EORTC

Stanford Investigator(s):

Intervention(s):

  • Drug: Lomustine
  • Drug: ABT-414
  • Drug: Temozolomide

Phase:

Phase 2

Eligibility


Inclusion Criteria:

Adult participants (greater than or equal to 18 years old):

   - Histologically confirmed de novo (primary) Glioblastoma Multiforme with unequivocal
   tumor progression or recurrence.

   - In case of testing at the time of first progression: either at least 3 months after
   the end of radiotherapy or have tumor progression that is clearly outside the
   radiation field or have tumor progression unequivocally proven by surgery/biopsy

   - Absence of any psychological, familial, sociological or geographical factors
   potentially hampering compliance with the study protocol and follow-up schedule; such
   conditions should be assessed with the patient before registration in the trial.

   - Availability of adequate biological material (formalin-fixed paraffin embedded [FFPE]
   tumor) for central testing of Epithelial Growth Factor Receptor (EGFR) amplification

   - Presence of EGFR amplification confirmed by central assessment; participants with
   undetermined EGFR status are excluded

   - World Health Organization (WHO) Performance status 0 - 2

   - No more than one line of chemotherapy (concurrent and adjuvant Temozolomide based
   chemotherapy including in combination with another investigational agent is considered
   one line of chemotherapy). Chemotherapy must have been completed at least 4 weeks
   prior to randomization.

   - Post surgery MRI within 48 hours following surgery, however an MRI scan has to be done
   within 2 weeks prior to randomization.

   - Surgery completed at least 2 weeks before randomization and patients should have fully
   recovered as assessed by investigators.

   - Renal function: calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault
   formula.

   - Liver function: bilirubin < 1.5× upper limit of the normal range (ULN), alkaline
   phosphatase and transaminases (ASAT) < 2.5× ULN

Pediatric sub-study participants (less than 18 years old):

   - Histologically proven high grade glioma (HGG: WHO grade III glioma [e.g anaplastic
   astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma], grade IV
   glioma [e.g glioblastoma, gliosarcoma] or diffuse intrinsic pontine glioma [DIPG]).

   - Must either have recurrent/progressive tumor or, if newly diagnosed, have completed
   any planned radiation therapy at least 4 weeks prior to first dose of ABT-414.

   - The tumor tissue must have been determined to have EGFR amplification, (by local or
   other testing service).

   - Availability of adequate biological material for retrospective confirmatory central
   testing of EGFR amplification

   - Participant has sufficiently recovered from previous therapy. The investigator
   believes that benefit of treating the pediatric subject with ABT-414 outweighs the
   expected risks and that this treatment is in the best interests of the pediatric
   subject.

   - Renal function: calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault
   formula for pediatric patients ≥12 years of age and estimated glomerular filtration
   rate ≥ 30 mL/min/1.73 m2 by modified Schwartz equation for pediatric patients < 12
   years of age.

   - Liver function: Total bilirubin <= 1.5× upper limit of the normal range (ULN),
   Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 3× ULN.
   Participants with Gilbert's syndrome documented in medical history may be enrolled if
   total bilirubin is < 3 times ULN. Not allowed are participants with known chronic
   liver disease and/or cirrhosis.

Exclusion Criteria:

Adult population (greater than or equal to 18 years old):

   - Prior treatment with nitrosoureas

   - Prior treatment with bevacizumab

   - Previous exposure to Epithelial Growth Factor Receptor (EGFR) targeted agents,
   including EGFRvIII targeting agents

   - Prior discontinuation of temozolomide chemotherapy for toxicity reasons

   - Prior Radiation Therapy (RT) with a dose over 65 Gy, stereotactic radiosurgery or
   brachytherapy unless the recurrence is histologically proven

   - Previous other malignancies, except for any previous malignancy which was treated with
   curative intent more than 5 years prior to randomization, and except for adequately
   controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or
   carcinoma in situ of the cervix

   - Women of childbearing potential must have a negative serum or urine pregnancy test
   (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to
   randomization.

   - No history of wheat allergies and Coeliac disease.

   - No EIAED, patients who require anti-convulsant therapy must be taking non-enzyme
   inducing antiepileptic drugs (non-EIAED). Patients previously on EIAED must be fully
   switched to non-EIAED at least 2 weeks prior to randomization.

Pediatric sub-study (less than 18 years old):

   - (For recurrent disease) No prior RT with a dose over 65Gy to the brain, stereotactic
   radiosurgery or brachytherapy unless the recurrence is histologically proven

   - No current or recent (within 4 weeks or 5 half-lives (whichever is shorter) before
   enrollment) treatment with another investigational drug

   - Female participants of childbearing potential must have a negative serum or urine
   pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72
   hours prior to randomization.

Ages Eligible for Study

N/A - 99 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Leah White
650-725-4708
Recruiting