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NCT02303678 : D2C7 for Adult Patients With Recurrent Malignant Glioma |
Phase | Phase 1 |
Ages | Min: 18 Years Max: N/A |
Eligibility | 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 procedures.
- 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 confirmation;
- 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 therapy;
- Prior chemotherapy (non-alkylating agents) within 2 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy. |
Links | Permanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02303678
| Link to official Clinicaltrials.gov listing
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Locations |
Durham,
North Carolina
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Facility: Preston Robert Tisch Brain Tumor Center at Duke
Investigator:
Contact:
Stevie Threatt Phone: 919-684-5301
Click HERE to send email to this center
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