Status:
TERMINATED
Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anatomic Stage IV Breast Cancer AJCC v8
Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This trial studies the side effects and how well ketoconazole works before surgery in treating patients with glioma that has come back or breast cancer that has spread to the brain. Ketoconazole is an...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if ketoconazole alters the tGLI1 activation signature (tGAS) which is consisted of eight validated tGLI1 regulated genes (CD24, CD44, VEGF-A, VEGF-C, VEGFR2, TEM7,...
Eligibility Criteria
Inclusion
- Subjects must have a history of:
- Histologically confirmed primary breast cancer including primary invasive and metastatic breast cancers with imaging findings consistent with brain metastasis. In the event that a patient presents with an initial diagnosis of metastatic breast cancer with imaging findings of a new brain metastases and unequivocal imaging findings of a primary breast cancer, consideration for study enrollment requires approval from the study chair (primary cohort)
- OR
- Histologically confirmed primary glioma including astrocytoma or oligodendroglioma of any World Health Organization grade with imaging findings consistent with recurrent or progressive disease (exploratory cohort). Patients with ependymoma will not be included.
- Subjects must be undergoing surgical resection for clinical purposes with anticipated resection of at least 300 mg of tissue.
- Patients with any prior number of radiation (including brain radiation), chemotherapy, or surgical interventions will be eligible for this protocol.
- The effects of ketoconazole on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document (either directly or via a legally authorized representative).
Exclusion
- Subjects with contraindication to ketoconazole including:
- Prior allergic reaction or intolerance of ketoconazole
- Known active hepatitis
- QTc prolongation (based on electrocardiography \[EKG\] obtained within 21 days of enrollment, with a threshold of \>450 ms in males and \>470 ms in female)
- Known liver cirrhosis will be excluded from enrollment
- Positive serum pregnancy test within 21 days of enrollment
- Subjects currently taking medications that are included in the contraindicated concurrent medications section of the Food and Drug Administration (FDA) approved indications for ketoconazole will be required to complete a seven day wash out period prior to consideration for enrollment.
- Subjects for whom collection of blood, or tissue samples is unsafe or clinically inadvisable.
- Pregnant women are excluded from this study because ketoconazole is a Class B agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ketoconazole, breastfeeding should be discontinued if the mother is treated with ketoconazole.
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03796273
Start Date
March 13 2019
End Date
October 23 2022
Last Update
September 19 2024
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157