Clinical Trial Details
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NCT01906385 : Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioblastoma
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. Planned stereotactic biopsy as standard of care (ie, for confirmation of disease

2. At least 18 years of age

3. Ability to understand the purposes and risks of the study and has signed a written
informed consent form approved by the investigator's IRB/Ethics Committee

4. Histologically confirmed glioblastoma

5. Progression following both standard combined modality treatment with radiation and
temozolomide chemotherapy, as well as anti-angiogenic therapy (ie, bevacizumab;
patients not eligible for or refusing antiangiogenic therapy will also be allowed)

6. For cohorts 1-3, tumor volumes limited to 1.5cc, as calculated under 4.1 Inclusion

7. Recovered from toxicities of prior therapy to grade 0 or 1

8. ECOG performance status of 0 to 2

9. Life expectancy of at least 2 months

10. Acceptable liver function:

- Bilirubin = 1.5 times upper limit of normal

- AST (SGOT) and ALT (SGPT) = 3.0 times upper limit of normal (ULN);

11. Acceptable renal function:

- Serum creatinine =1.5xULN

12. Acceptable hematologic status (without hematologic support):

- ANC =1000 cells/uL

- Platelet count =75,000/uL

- Hemoglobin =9.0 g/dL

13. All women of childbearing potential must have a negative serum pregnancy test and male
and female subjects must agree to use effective means of contraception (surgical
sterilization or the use or barrier contraception with either a condom or diaphragm in
conjunction with spermicidal gel or an IUD) with their partner from entry into the
study through 6 months after the last dose

Exclusion Criteria:

- The subject has evidence of acute intracranial or intratumoral hemorrhage either by
MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes,
punctate hemorrhage, or hemosiderin are eligible.

- The subject is unable to undergo MRI scan (eg, has pacemaker).

- The subject has not recovered to National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) v4.0 Grade = 1 from AEs (except alopecia, anemia
and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or
other medications that were administered prior to study drug.

- The subject is pregnant or breast-feeding.

- The subject has serious intercurrent illness, such as:

- hypertension (two or more blood pressure [BP] readings performed at screening of
> 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment

- Non-healing wound, ulcer, or bone fracture

- Significant cardiac arrhythmias

- Untreated hypothyroidism

- Unhealed rectal or peri-rectal abscess

- Uncontrolled active infection

- Symptomatic congestive heart failure or unstable angina pectoris within 3 months
prior study drug

- Myocardial infarction, stroke, transient ischemic attack within 6 months

- Gastrointestinal perforation, abdominal fistula, intra- abdominal abscess within
1 year

- History or clinical evidence of pancreatitis within 2 years

- The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding

- The subject has received any of the following prior anticancer therapy:

- Non-standard radiation therapy such as brachytherapy, systemic radioisotope
therapy (RIT), or intra-operative radiotherapy (IORT) to the target site. SRS is
allowed as long as the target lesion for this study has not been the treatment

- Targeted therapy (including investigational agents and small-molecule kinase
inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5
half-lives, whichever is shorter, prior first dose of study drug

- Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21
days prior to first dose of study drug

- Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose
chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days,
prior to first dose of study drug

- Prior treatment with carmustine wafers
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