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Title:
STM-03: Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies
Protocol Number:
J1581
Phase:
Phase I
Physician:
Matthias Holdhoff
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This study is being done to determine the highest dose of the drug PAC-1 (first procaspase-activating compound)that can be safely given to people with solid tumor cancers and lymphoma (PART 1). PAC-1 in combination with temozolomide will be studied in patients with high grade glioma (PART 2). Part 2 will not begin until Part 1 is complete.
Eligibility:
* Diagnosis of advanced cancer that has failed/intolerant of standard therapy. (PART 1)* No history of brain metastases, seizures or or underlying brain injury* Adequate performance status* At least 18 years of age* Adequate liver, kidney and bone marrow function* Measurable disease* No surgery within 4 weeks* No cytotoxic chemotherapy within 3 weeks (6 weeks for nitrosureas)* No uncontrolled HIV* No active infection* No severe, uncontrolled medical condition* No radiation therapy to more than 25% of the bone marrow (No whole pelvic radiation)* No prior allogeneic BMT or organ transplantation* Diagnosis of high grade glioma, GBM or anaplastic astrocytoma after progression following standard first line therapy (PART 2)*
Treatment:
PAC-1 is an oral drug given on days 1-21 of a 28 day cycle. PAC-1 is taken on an empty stomach. Disease reassessment will be done every 2 months. Patients may continue treatment until disease progression, unacceptable side effects or they wish to discontinue. The study will have 2 parts.PART 1: PAC-1 taken alone at various dose escalations. PART 2: PAC-1 in combination with temozolomide.
Population:
Adult
Last Update
03/05/2019 05:03 AM