Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02770378 : A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients with a diagnosis of glioblastoma World Health Organization (WHO) grade IV
(histologically confirmed by a pathologist). Patients with prior low-grade glioma are
eligible if histological transformation to WHO grade IV glioblastoma was confirmed.

- Progression (according to RANO criteria) after prior radiation and temozolomide
treatment

- No more than 3 prior episodes of tumor progression

- ? 4 weeks between surgical resection or chemotherapy

- ? 12 weeks since last radiotherapy

- Patients > 18 years of age.

- Karnofsky performance status (KPS) of ? 70%

- Stable steroid dose for ? 1 week

- Hemoglobin ? 10 g/l

- Absolute neutrophil count (ANC) > 10³ cells/µl

- Platelet count > 100/µl

- Maximum 5 years since last Pneumovax (or equivalent) and varicella vaccination

- Serum creatinine, aspartat-aminotransferase (AST) and bilirubin ? 1.5 times the upper
limit of normal (ULN)

- Female patients of childbearing potential with a negative pregnancy test within 7 days
of initiation of study treatment. Postmenopausal women must be amenorrheic for at
least 12 months to be considered of non-childbearing potential.

- Male and female patients of reproductive potential who agree to employ an effective
method of birth control throughout the study and for up to 6 months following
discontinuation of study drug. Patients must be counseled on the possibility of
cryopreservation of oocytes or sperm.

- Signed informed consent prior to initiation of any study procedure (must understand,
voluntarily sign the informed consent form and be able to adhere to the study visit
schedule and other protocol requirements).

Exclusion Criteria:

- Female patients who are pregnant or breast-feeding

- Any uncontrolled/unstable medical condition except glioblastoma, including but not
limited to uncontrolled/unstable hypertension, uncontrolled/unstable diabetes,
uncontrolled endocrinopathies of any kind, uncontrolled/unstable psychiatric
conditions

- Renal failure (eGFR < 60 ml/min)

- Active infection, including pneumonia as shown on X-ray

- Therapeutic anticoagulation use

- Prior stereotactic radiosurgery

- Radiation implants

- Radiolabeled monoclonal antibody therapy unless there was unequivocal disease
progression (e.g. a new lesion or biopsy-confirmed recurrence)

- QT interval (QTc) < 470 msec (based on the mean value of triplicate ECGs), family or
personal history of long or short QT syndrome, Brugada syndrome, or known history of
QTc prolongation or Torsade de Pointes

- Uncontrolled electrolyte disorders that can aggravate the effects of a QTc-prolonging
drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia)

- History of severe hypersensitivity reaction (? grade 3) to any component of the
investigational drugs or excipients

- Unable to undergo contrast-enhanced MRI

- Patients who have been treated with any investigational agent(s) within 28 days of the
first day of administration of study drugs

- Current active second malignancy other than non-melanoma skin cancers and
post-treatment of localized prostate cancer. Patients are not considered to have a
currently active malignancy if they are in complete remission for > 3 years prior to
study

- Known HIV infection, active Hepatitis B or C infection

- Any ongoing toxicity from prior anti-cancer therapy that is > grade 1 and/or that is
progressing in severity (except alopecia) and delayed recovery following last
temozolomide cycle

- Additional anti-cancer treatment for glioblastoma other than study drug and supportive
measures (i.e. dexamethasone)

- Patients refusing consent for registration, storage, and processing of individual
disease characteristics, information on the course of the disease, and information
obtained from the family physician and/or other physicians involved in the treatment
of the patient about study participation.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02770378      |      Link to official Clinicaltrials.gov listing
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