Clinical Trial Details
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NCT02303678 : D2C7 for Adult Patients With Recurrent Malignant Glioma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Dose escalation only: Patients must have a recurrent supratentorial WHO grade III or
IV malignant glioma based on imaging studies;

- Dose expansion only: Patients must have a recurrent supratentorial WHO grade IV
malignant glioma based on imaging studies

- Prior histopathology consistent with a supratentorial WHO grade III (dose escalation
only) or IV (dose escalation and dose expansion) malignant glioma;

- Following biopsy, prior to administration of D2C7-IT, the presence of recurrent tumor
must be confirmed by histopathological analysis;

- Age = 18 years of age;

- Karnofsky Performance Status (KPS) = 70%;

- Laboratory Values:

- Platelet Count = 125,000 cells/mm3 prior to biopsy. Platelets = 100,000 cells/mm3
prior to infusion;

- Hemoglobin = 10 gm/dL prior to biopsy;

- Absolute neutrophil count (ANC) = 1500 cells/mm3 prior to biopsy;

- Serum creatinine = 1.2 x the upper limit of normal (ULN) prior to biopsy;

- Liver Function: Total bilirubin = 1.6 mg/dL prior to biopsy; AST/ALT = 2.5 x the
ULN prior to biopsy;

- Prothrombin (PT) and activated Partial Thromboplastin Time (aPTT) = 1.2 x upper
limit of normal (ULN) prior to biopsy. Patients with prior history of
thrombosis/embolism are allowed to be on anticoagulation, understanding that
anti-coagulation will be held in the peri-operative period per the neurosurgical
team's recommendations. Low molecular weight heparin (LMWH) is preferred. If a
patient is on warfarin, the international normalized ratio (INR) is to be
obtained and value should be below 2.0 prior to biopsy;

- Ability to comply with study and follow-up procedures;

- If the patient is a sexually active female of child bearing potential, whose partner
is male, or if the patient is a sexually active male, whose partner is a female of
child bearing potential, the patient must agree to use appropriate contraceptive
measures for the duration of the treatment of the tumor and for 6 months afterwards as
stated in the informed consent. Female patients of child bearing potential must have a
negative serum pregnancy test at the time of screening and within 48 hours of starting
the D2C7-IT infusion

- Patients will sign an IRB-approved informed consent form prior to any study-related

- Able to undergo brain MRI with and without contrast.

Exclusion Criteria:

- Prior, unrelated malignancy requiring current active treatment with the exception of
cervical carcinoma in situ and adequately treated basal cell or squamous cell
carcinoma of the skin;

- Pregnant or breastfeeding;

- Patients with contrast-enhancing tumor component crossing the midline, actively
growing multi-focal tumor, infratentorial tumor or tumor dissemination (subependymal
or leptomeningeal);

- Patients with clinically significant increased intracranial pressure (e.g., impending
herniation), uncontrolled seizures, or requirement for immediate palliative treatment;

- Patients with a known allergy to Gadolinium-DTPA;

- Unstable systemic disease in the opinion of the treating physician, for example active
infection requiring IV antibiotics;

- Patients on greater than 4mg per day of dexamethasone within the 2 weeks prior to
admission for D2C7-IT infusion;

- Patients with worsening steroid myopathy (history of gradual progression of bilateral
proximal muscle weakness, and atrophy of proximal muscle groups);

- Less than 12 weeks from radiation therapy, unless progressive disease outside of the
radiation field or 2 progressive scans at least 4 weeks apart or histopathologic

- Treated with immunotherapeutic agents within 4 weeks before enrollment, unless the
patient has recovered from the expected toxic effects of such therapy;

- Treated with antiangiogenic agents (like bevacizumab) within 4 weeks before biopsy;

- Treated with alkylating agents within 4 weeks before enrollment (6 weeks for
nitrosoureas) or treated within 1 week before enrollment with daily or metronomic
chemotherapy, unless the patient has recovered from the expected toxic effects of such

- Prior chemotherapy (non-alkylating agents) within 2 weeks before enrollment, unless
the patient has recovered from the expected toxic effects of such therapy.
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