International Multicenter Phase I trial of Hydroxyurea in Combination with Dose-Intense Temozolomide in Recurrent Glioblastoma. - HUTMZ

Vrije Universiteit Medisch Centrum0 个研究点目标入组 49 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Histologically or cytologically confirmed glioblastoma multiforme
•Patients may have had any number of prior therapies for glioblastoma.
•Patients must be at least 28 days from any investigational agent, 28 days from
•prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from
•vincristine, 42 days from nitrosoureas, 21 days from procarbazine
•administration), and 7 days for patients who received metronomic chemotherapy
•or non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic
•Age >=18 years en mentally competent
•Karnofsky Performance Status (KPS) >=60%
•Participants must have normal organ and marrow function as defined below
•(leukocytes >=3,000/mcL, absolute neutrophil count >=1,500/mcL, platelets
•>=100,000/mcL, total bilirubin within normal institutional limits,
•AST(SGOT)/ALT(SGPT) <=2.5 × institutional upper limit of normal, creatinine
•below upper limit of normal institutional limits OR creatinine clearance >=60
•mL/min/1.73 m2 for patients with creatinine levels above institutional normal)
•Progressive disease on contrast-enhanced brain CT or MRI as defined by RANO

•Participants who are receiving any other investigational agents or devices in
•investigation for glioblastoma.
•No previous treatment with an anti-VEGF inhibitor.
•History of allergic reactions attributed to compounds of similar chemical
•composition to temozolomide and/or hydroxyurea.
•Uncontrolled intercurrent illness including, that would limit compliance with
•study requirements.
•Pregnant women
•HIV-positive participants on combination antiretroviral therapy
•Patients with a history of a different malignancy are ineligible except for the
•following circumstances: if they have been disease-free for at least 3 years
•and are deemed by the investigator to be at low risk for recurrence of that
•malignancy; patients with treated cervical cancer in situ, and basal cell or
•squamous cell carcinoma of the skin. Patients will not be eligible if they have
•evidence of other malignancy requiring therapy other than surgery within the
•last 3 years.
•Major surgery within 2 weeks of start of study drug; or not fully recovered
•from any side effects of previous procedures.
•Presence of extra-cranial metastatic disease.

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