International Multicenter Phase I trial of Hydroxyurea in Combination with Dose-Intense Temozolomide in Recurrent Glioblastoma.
- Conditions
- High grade glioma10029211brain tumor
- Registration Number
- NL-OMON50467
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 49
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
acid, etc.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method