Clinical Trial Details
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NCT03463733 : Hydroxy-urea and Temozolomide in Patients With a Recurrent Malignant Brain Tumor (Glioblastoma)
PhasePhase 1
AgesMin: N/A Max: N/A
Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed glioblastoma

2. 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.

3. Age =18 years. Because no dosing or adverse event data are currently available on the
use of hydroxyurea in combination with temozolomide in participants <18 years of age,
children are excluded from this study, but will be eligible for future pediatric

4. Karnofsky Performance Status (KPS) =60%

5. Participants must have normal organ and marrow function as defined below:

- leukocytes =3,000/microliter (mcL)

- absolute neutrophil count =1,500/mcL

- platelets =100,000/mcL

- total bilirubin within normal institutional limits

- Aspartate transaminase (AST; SGOT)/alanine transaminase (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.

6. Progressive disease on contrast-enhanced brain CT or MRI as defined by Response
Assessment in Neuro-Oncology (RANO) Criteria [22], or have documented recurrent
glioblastoma on diagnostic biopsy. Patients who have been previously treated with
bevacizumab therapy that have T2-weighted or FLAIR MRI sequences considered to be
progressive disease by the study investigator but have no contrast-enhancing areas of
recurrent disease are eligible.

7. Interval of at least 2 weeks from any prior neurosurgical resection (1 week for
intracranial biopsy) to start of study drug; and patient must have adequate wound

8. Interval of at least 12 weeks from prior radiotherapy unless there is either: a)
histopathologic confirmation of recurrent tumor, or b) new enhancement on MRI outside
of the radiation treatment (RT) field.

9. Because cytotoxic agents such as temozolomide and hydroxyurea are known to be
teratogenic, 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 she or her partner is participating in this study, she
should inform her treating physician immediately. Men treated or enrolled on this
protocol must also agree to use adequate contraception prior to the study, for the
duration of study participation, and 4 months after completion of temozolomide and
hydroxyurea administration.

10. Patients must have archival tumor tissue available for molecular analysis and must be
willing to consent for this tissue to be analyzed as part of this study. However, if
no archival tumor tissue is available, the patient will not be excluded from the

11. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Participants who are receiving any other investigational agents or devices in
investigation for glioblastoma.

2. Patients must not have been previously treated with an anti-vascular endothelial
growth factor (VEGF) inhibitor.

3. History of allergic reactions attributed to compounds of similar chemical composition
to temozolomide and/or hydroxyurea.

4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

5. Pregnant women are excluded from this study because hydroxyurea and temozolomide have
known 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
hydroxyurea and temozolomide, breastfeeding should be discontinued if the mother is
treated with hydroxyurea and temozolomide.

6. HIV-positive participants on combination antiretroviral therapy are ineligible because
of the potential for pharmacokinetic interactions with hydroxyurea. In addition, these
participants are at increased risk of lethal infections when treated with
marrow-suppressive therapy. Appropriate studies will be undertaken in participants
receiving combination antiretroviral therapy when indicated.

7. 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.

8. Major surgery (not including minor diagnostic procedures such as lymph node biopsy)
within 2 weeks of start of study drug; or not fully recovered from any side effects of
previous procedures.

9. Presence of extra-cranial metastatic disease.
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