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. 2021 Sep 28;16:6593–6644. doi: 10.2147/IJN.S323831

Table 9.

Characteristics of Searched Clinical Studies

I. An Early Phase Study of Abraxane Combined with Phenelzine Sulfate in Patients with Metastatic or Advanced Breast Cancer168
(8 participants)
Metastatic Breast Cancer
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
A Phase Ib Safety and Pharmacokinetics (PK)/ Pharmacodynamics (PD) Study to Determine the Dosage of Abraxane in Combination with Phenelzine Sulfate in Metastatic or Inoperable Locally Advanced Breast Cancer
Study Phase:
Phase 1b
Study Objectives:
To determine the safety and efficacy after administration of Abraxane and phenelzine sulfate (Nardil) for metastatic or locally advanced breast cancer.
Study design:
Interventional, open label, non-randomised, cumulative cohort group design (5 groups) with a defined target toxicity fraction of 30% and a corresponding margin of 10%.
The toxicity fraction is defined for clinical application and study as the number of study subjects receiving particular dose who experience a Dose-Limiting Toxicity.
Study Status: completed (October 30, 2019)		 Arms:
1. Nanoparticle albumin-bound paclitaxel. Abraxane i.v. (100mg/m2)
2. Phenelzine Sulfate (Nardil) p.o. initial dose of 15mg/d to a max dose of 90mg/d		 Brief Summary
Participants diagnosed with metastatic breast cancer or inoperable locally advanced breast cancer of age 18 years or above will receive combination of intravenously administered Abraxane and phenelzine sulfate orally. Both of the medicinal products have been applied in clinical practice for years however the combination of both has not been given for cancer therapy.
The aim of the study is to investigate the effect of those two drugs together. Safety and efficacy will be assessed weekly for the period of 3 administration cycles.
Abraxane administration is given weekly for the first 3 weeks of a 4-week period for 3 consecutive cycles.
Phenelzine sulfate will be given daily for 3 cycles.
Study is divided in five cohort groups each will be given a progressively increasing dose of phenelzine sulfate.

Primary Outcome Measures
Dose-Limiting Toxicity events assessed during the initial fifty-six (56) days
Secondary Outcome Measures
1. Abraxane Cmax
2. Abraxane Tmax
3. Abraxane Half-life
4. Abraxane AUC
5. Nardil Cmax
6. Nardil Tmax
7. Nardil Half-life
8. Nardil AUC
9. Circulating Tumour Cell burden:
 a. PDL1 expressing Circulating Tumour Cell
 b. HER2 expressing Circulating Tumour Cell
 c. FFPE Tumour cells
 d. FFPE Stoma cells
 e. FFPE Cancer Stem Cells
II. Nanoparticle Albumin-Bound Rapamycin in Treating Patients With Advanced Cancer With mTOR Mutations169
(2 participants)
Advanced Malignant Neoplasm; Cervical Squamous Cell Carcinoma; Endometrial Carcinoma; Malignant Uterine Neoplasm; Recurrent Carcinoma of Bladder, Breast, Cervical, Head, and Neck, Ovarian, Prostate; Recurrent Malignant Neoplasm; Recurrent Renal Cell Carcinoma; Solid Neoplasm Stage III; Bladder Cancer Stage: III, IVA, IVB; Prostate Cancer Stage III & Stage IV; Renal Cell Cancer Stage IIIA & Stage IVA; Breast Cancer Stage: IIIA, IIIB, IIIC, IV; Cervical Cancer Stage: IIIA, IIIB, IVB; Ovarian Cancer Stage: IIIB, IIIC, IV
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
A Pilot Study of a Rapid Access Platform for Investigational Drugs (RAPID) in Advanced Cancers
Study Phase: Phase 1
Study Objectives:
PRIMARY OBJECTIVES:
 I. To investigate efficacy.
 II. To determine the confirmed response rate of nab-rapamycin
SECONDARY OBJECTIVES:
 I. To estimate other clinical outcomes
 II. To assess the adverse event profile
 III. To assess the clinical benefit
 IV. To assess progression-free survival and overall survival of these patients.
TERTIARY OBJECTIVES:
 I. To assess quality of life and to correlate HRQOL/symptoms with genomic markers.
 II. To assess the rate of individual mTOR pathway aberrations
Study design: Interventional, Open label, Single group assignment
Study dates: Study start date: January 2016; Study end date: April 24, 2018
Study Status: completed		 Arms:
1. Nanoparticle albumin-bound rapamycin

Interventions
1. Laboratory Biomarker Analysis
2. Quality-of-Life Assessment		 Brief Summary
This pilot study investigates clinical response to rapamycin administered to patients with advanced cancer and having abnormal genetic test results in a protein called mechanistic target of rapamycin (mTOR). Patients are given nanoparticle albumin-bound rapamycin, which may inhibit the growth of cancer cells by influencing the mTOR enzyme, required for cell growth.

Primary Outcome Measures
1. Proportion of confirmed responses (clinical benefit)
Secondary Outcome Measures
1. Incidence of adverse events
2. Relationship of adverse events to study treatment
3. Survival time
4. Time to disease progression
Other Outcome Measures
1.Quality of life (EORTC QLQ-C30 questionnaire)
2. Rate of mTOR pathway aberrations
III. A Study of CriPec® Docetaxel Given to Patients With Solid Tumours170
(33 participants)
Metastatic Cancer, Solid Tumors
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
A Phase I Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of CriPec® Docetaxel in Patients With Solid Tumours
Study Phase: Phase 1
Study Objectives:
To assess safety and tolerability
Study design:
Open Label, Single Group Assignment
Study dates:
Study start date: August 2015
Study end date: July 2018
Study Status: completed		 Arms:
1. CriPec® docetaxel
Docetaxel containing nanoparticle
3 weekly IV dose		 Brief Summary
The aim of this study is to determine safety by finding the highest safe dose of CriPec® docetaxel that can be administered to patients with solid tumours
Primary Outcome Measures
1. Incidence of adverse events (grade 3 or 4) as a measure of safety and tolerability.
2. Incidence of abnormal clinical laboratory values as a measure of safety and tolerability.
3. Incidence abnormal of electrocardiogram findings as a measure of safety and tolerability.
4. Incidence of adverse events at the Maximum Tolerated Dose (grade 3 or 4)
5. Incidence of abnormal lab values at the Maximum Tolerated Dose
6. Incidence of ECG abnormalities at the Maximum Tolerated Dose
7. Pharmacokinetics: (Tmax), (Cmax), volume of distribution (Vd), half life (t1/2), total body clearance (CL) and area under the concentration-time curve (AUC)
Secondary Outcome Measures
1. Early signs of anti-tumor efficacy (overall response rate)
2. Early signs of anti-tumor efficacy (duration of response)
IV. PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer171
(20 participants)
Ovarian Cancer Stage: IIIB, IIIC, IV; Breast Cancer Stage: IIIB, IIIc, IV; Stomach Cancer; Stage III & Stage IV with Metastases; Pancreas Cancer, Stage III& Stage IV
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
Intraperitoneal Aerosolization of Albumin-stabilized Paclitaxel Nanoparticles for Stomach, Pancreas, Breast and Ovarian Cancer
Study Phase: Phase 1
Study Objectives:
To assess maximal tolerated dose via dose escalation combined with pharmacokinetic/pharmacodynamic modelling which incorporates, in addition to plasma, tumor tissue, and peritoneal drug concentrations, biomarkers of toxicity and efficacy
Study design:
Interventional,
Randomized,
Single Group Assignment,
Double blinded,
Multicenter
Study dates: Study start date: September 16, 2017; Study end date: May 6, 2020
Study Status: completed		 Arms:
1. PIPAC with Abraxane (35 mg/m2)
2. PIPAC with Abraxane (70 mg/m2)
3. PIPAC with Abraxane (90 mg/m2)
4. PIPAC with Abraxane (112,5 mg/m2)
5. PIPAC with Abraxane (140 mg/m2)		 Brief Summary
The study is designed to assess the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac) administered with repeated pressurized intraperitoneal aerosol chemotherapy
Primary Outcome Measures
1. Maximally tolerated dose of Abraxane (dose limiting toxicities)
Secondary Outcome Measures
1. Surgical morbidity will be measured (Dindo-Clavien classification)
2. Maximum plasma concentration of Abraxane
3. Area Under the Curve (AUC)
4. Pharmacodynamics of Abraxane will be analyzed using tumor markers (CA15.3 for breast cancer, CEA for stomach cancer, CA19.9 for pancreatic cancer, CA125 in case of ovarian cancer).
5. Pharmacodynamics (PD) of Abraxane will be analyzed by tumor biopsies
6. Quality of Life (EORTC QLQ-C30 questionnaire)
7. Quality of Life (FACT-G questionnaire)
8. Neutropenia (neutrophil count)
9. Decreased platelet count
V. Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer172
(38 participants)
Advanced Malignant Solid Neoplasm; ALK Positive Metastatic Pancreatic Adenocarcinoma Pancreatic Cancer Stage III & Stage IV
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
A Phase I Study of Ceritinib (LDK378), a Novel ALK Inhibitor, in Combination With Gemcitabine-Based Chemotherapy in Patients With Advanced Solid Tumors
Study Phase: Phase 1
Study Objectives:
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended Phase II dose of ceritinib in combination with gemcitabine (gemcitabine hydrochloride) alone, gemcitabine/nab-paclitaxel and gemcitabine/cisplatin in patients with advanced solid malignancies.
SECONDARY OBJECTIVES:
I. Assess the safety profile
II. Determine the pharmacokinetic characteristics
III. Determine the preliminary efficacy of the study drug combinations.
TERTIARY OBJECTIVES:
I. Investigate potential biomarkers of efficacy
Study design:
Interventional, Non-randomized, Open label, Parallel assignment
Study dates: Study start date: January 8, 2015; Study end date: February 12, 2019
Study Status: completed		 Arms:
1. Ceritinib maximum tolerated dose (MTD) then gemcitabine alone
Interventions 1:
Drug: Ceritinib
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

2. Ceritinib maximum tolerated dose then with gemcitabine and paclitaxel albumin-stabilized nanoparticle
Interventions 2:
Drug: Ceritinib
Drug: Gemcitabine Hydrochloride
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

3. Ceritinib maximum tolerated dose then with gemcitabine and cisplatin
Interventions 3:
Drug: Ceritinib
Drug: Cisplatin
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study		 Brief Summary
Study to determine safety - the maximum tolerated dose and recommended Phase II dose for chemotherapy with Ceritinib (LDK378) in patients with advanced solid tumors

Primary Outcome Measures
1. Maximum tolerated dose and recommended Phase II dose of ceritinib in combination with gemcitabine hydrochloride alone
2. Maximum tolerated dose and recommended Phase II dose of ceritinib in combination with gemcitabine hydrochloride and cisplatin
3. Maximum tolerated dose and recommended Phase II dose of ceritinib in combination with gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation
Secondary Outcome Measures
1. Incidence of adverse events of Ceritinib in combination treatment with gemcitabine hydrochloride chemotherapy
Safety profile based on event type, frequency, severity, time relationship, seriousness and relationship to study treatment.
2. Pharmacokinetics of Ceritinib and Gemcitabine hydrochloride combined: A population based pharmacokinetic model to estimate individual AUC or clearance of Ceritinib
3. Pharmacokinetics of Ceritinib, Gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation; A population based pharmacokinetic model will be developed to estimate individual AUCs or CL of Ceritinib in combination with Gemcitabine hydrochloride and nab-Paclitaxel.
4. Pharmacokinetic characteristics of paclitaxel albumin-stabilized nanoparticle formulation, and cisplatin;
A population based pharmacokinetic model will be developed to estimate individual AUCs or CL of Ceritinib in combination with Gemcitabine hydrochloride and Cisplatin.
5. Progression free survival
6. Response rate as estimated by the RECIST 1.1
Other Outcome Measures:
1. Tumor biomarkers and levels of serum
VI. Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients173
(12 participants)
Prostate Cancer
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
Phase 1, Open Label Trial to Evaluate the Safety and Immunogenicity of PAN-301-1 in Cancer Patients
Study Phase: Phase 1
Study Objectives:
Study design:
Interventional, Sequential Assignment, Open label
Study dates: Study start date: December 2016;
Study end date: December 2018
Study Status: completed		 Arms:
1. PAN-301-1 (SNS-301) Vaccine

Intervention:
Biological: PAN-301-1		 Brief Summary
Research phase 1 study of PAN-301-1 (SNS-301), a HAAH directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed prostate cancer, aiming to assess safety parameters.
Primary Outcome Measures
Safety assessment to determine maximum tolerated dose by monitoring the development of adverse events and dose-limiting toxicity
Secondary Outcome Measures
Safety assessment by monitoring administration site reactions, abnormal lab values and adverse events
VII. Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancer174
(62 participants)
Stage III Intrahepatic Cholangiocarcinoma AJCC v7 Stage IIIA Gallbladder Cancer AJCC v7 Stage IIIB Gallbladder Cancer AJCC v7 Stage IVA Gallbladder Cancer AJCC v7 Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7 Stage IVB Gallbladder Cancer AJCC v7 Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7 Unresectable Extrahepatic Bile Duct Carcinoma Unresectable Gallbladder Carcinoma
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
A Phase II Study of Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers
Study Phase: Phase 2
Study Objectives:
PRIMARY OBJECTIVES:
I. Determine the progression-free survival of gemcitabine hydrochloride (gemcitabine), cisplatin, and nab-paclitaxel in advanced, untreated biliary cancers.
SECONDARY OBJECTIVES:
I. Determine the response rate and disease control rate
II. Determine overall survival of gemcitabine, cisplatin, and nab-paclitaxel in advanced biliary cancers.
III. Evaluate the toxicity of gemcitabine, cisplatin, and nab-paclitaxel in advanced biliary cancers.
Study design:
Interventional, Single Group Assignment, Open - label
Study dates: Study start date: April 2, 2015; Study end date: August 13, 2020
Study Status: completed		 Arms:
1. Treatment (nab-paclitaxel, cisplatin, gemcitabine)
Intervention/treatment
Drug: Cisplatin
Given IV
Drug: Gemcitabine Hydrochloride
i.v.
Drug: Nab-paclitaxel
i.v.
Other: Laboratory Biomarker Analysis, Correlative studies		 Brief Summary
This study investigates the efficacy of the intervention drugs administered in patients with biliary cancers.

Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Incidence of adverse events
VIII. Radiosensitization of Multiple Brain Metastases Using AGuIX Gadolinium Based Nanoparticles175
(15 participants)
Brain Metastases
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
Phase I Clinical Study of Radiosensitization of Brain Metastases By Gadolinium Nanoparticles
Study Phase: Phase 1
Study Objectives:
To study safety and preliminary efficacy

Study design:
Interventional, open label, Single Group Assignment
Study dates:
Study start date: March 2016; Study end date: February 2019
Study Status: completed		 Arms:
1. AGuIX and radiotherapy

With the following escalation cohorts: 15 mg/kg, 30 mg/kg, 50 mg/kg, 75 mg/kg and 100 mg/kg

Intervention/treatment
Drug: AGuIX		 Brief Summary
Study investigates if AGuIX particles may increase the effectiveness of radiation therapy by sensitizing tumor cells to radiation. This trial studies the side effects and optimal dose of AGuIX when injected together with whole brain radiation therapy. The preliminary effectiveness of the combination of AGuIX and radiation therapy will be also assessed.

Primary Outcome Measures
1. Maximum tolerated dose of AGuIX given with the whole brain radiation therapy
Secondary Outcome Measures
1. Pharmacokinetic parameter of AGuIX particles - Cmax
2. Pharmacokinetic parameter of AGuIX particles - AUC
3. Pharmacokinetic parameter of AGuIX particles -T1/2
4. MRI to evaluate distribution of AGuIX particles in brain metastases and surrounding healthy tissue
5. MRI to assess intracranial progression-free survival
6. Overall survival
IX. Study to Evaluate CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors176
(146 participants)
Solid Tumors
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
Phase 1/2 Study of CORT125134 in Combination With Nab-paclitaxel in Patients With Solid Tumors
Study Phase: Phase 1/2
Study Objectives:
To assess the safety and to determine the preliminary efficacy
Study design:
Interventional, non-randomized, open label, Single Group Assignment, multicenter
Study dates: Study start date: May 2016; Study end date: May 2020
Study Status: completed		 Arm
CORT125134 with nab-paclitaxel

Intervention/treatment
CORT125134 with nab-paclitaxel p.o.
Nab-paclitaxel i.v.		 Brief Summary
The purpose of this study is to assess the safety and preliminary efficacy of the combination of drugs: CORT125134 and nab-paclitaxel administered in patients with solid tumors.

Primary Outcome Measures
1. Maximum Tolerated Dose of CORT125134
Secondary Outcome Measures
1. Incidence of Treatment-Related Adverse Events
Other Outcome Measures
1. Objective response rate, progression free survival, overall survival
2. Objective response rate, progression free survival, and overall survival in patients with GR-positive or GR negative solid tumors.
3. Pharmacokinetics: exposure-response
4. Pharmacodynamics: modulation of GR function, hormonal changes and FKBP5
X. Study of Topical SOR007 Ointment for Cutaneous Metastases177
(23 participants)
Cutaneous Metastasis
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
Phase 1/2 Dose-Rising, Safety, Tolerability and Efficacy Study of Topical SOR007 for Cutaneous Metastases
Study Phase: Phase 1/2
Study Objectives:
To evaluate the safety, tolerability and preliminary efficacy of SOR007 (in different concentrations)
Study design:
Interventional, Non-Randomized, Sequential Assignment, open-label, dose-rising
Study dates: Study start date: January 31, 2018; Study end date: April 29, 2020
Study Status: completed		 Arms:
1. SOR007 0.15%
(Uncoated Nanoparticle Paclitaxel) Ointment
2. SOR007 1.0% (Uncoated Nanoparticle Paclitaxel) Ointment
3. SOR007 2.0%
(Uncoated Nanoparticle Paclitaxel) Ointment

Intervention
Drug: Uncoated Nanoparticle Paclitaxel) Ointment		 Brief Summary
To study a topical nanoparticle paclitaxel ointment (SOR007) for the treatment of cutaneous metastases from non-melanoma cancer in adults.

Primary Outcome Measures
1. Incidence of treatment emergent adverse events
Secondary Outcome Measures
1. Difference in total area of eligible lesion(s) in the treatment area
2. Objective clinical response
3. Reduction in pain at the treatment area
4. Pharmacokinetic parameter – AUC
5. Pharmacokinetic parameter – Cmax
6. Pharmacokinetic parameter – Tmax
XI. PET Study With [89Zr]-Df-CriPec® Docetaxel178
(7 participants)
Solid Tumor
Selected Study Details Arms and Interventions Brief Description and Outcome Measures
Official Study Title:
A Clinical Phase I, Open-label, PET Study With [89Zr]-Df-CriPec® Docetaxel in Patients With Solid Tumours to Assess Biodistribution and Tumour Accumulation of [89Zr]-Df-CriPec® Docetaxel
Study Phase: Phase 1
Study Objectives:
To assess biodistribution and tumour accumulation of the drug administered.
Study design:
Open Label, Single Group Assignment
Study dates: Study start date: April 1, 2018; Study end date: May 8, 2020
Study Status: completed		 Arms:
1. [89Zr]-Df-CriPec® docetaxel		 Study with administration of [89Zr]-Df-CriPec® docetaxel in patients with solid tumours to assess biodistribution and tumour accumulation of the drug given.

Primary Outcome Measures
Detection (visual) of [89Zr]-Df-CriPec® docetaxel in tumour lesions Visual detection (absent/present) of tumor uptake
Detection (quantitative) of [89Zr]-Df-CriPec® docetaxel in tumour lesions
Secondary Outcome Measures
Dosimetry of [89Zr]-Df-CriPec docetaxel based on activity concentration and biodistribution
Optimal time point for PET imaging after [89Zr]-Df-CriPec® docetaxel administration
Linearity between [89Zr]-Df-CriPec® docetaxel and total docetaxel
Biodistribution of low dose dose [89Zr]-Df-CriPec® docetaxel before and after administration of therapeutic dose of CriPec® docetaxel.
XII. A Sunscreen Based on Bioadhesive Nanoparticles179
(13 participants)
Melanoma; UV Ray Skin Damage
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
Assessing the Safety and Efficacy of Multifunctional Skin-adhesive Nanoparticles for UV Protection in Humans
Study Phase: Phase 1
Study Objectives:
To evaluate the duration of protection and efficacy of a bioadhesive nanoparticle sunscreen
Study design:
Randomized, double blinded, parallel assignment
Study dates:
Study start date: July 17, 2017
Study end date: August 18, 2017
Study Status: completed		 Arms:
1. UV filtering agent and bioadhesive nanoparticles (BNPs)
2. Standard Sunscreen consisting of padimate O (7%) and oxybenzone (3%).
3. Sham Comparator:
A placebo strips with no UV filtering
4. Control, no agent applied.		 Brief Summary:
Study assesses the safety, sun protection factor (SPF) characteristics, and the duration of protection.

Primary Outcome Measures
Skin Reaction assessed by examination (evidence of irritation, inflammation, follicular occlusion).
XIII. NU-0129 in Treating Patients With Recurrent Glioblastoma or Gliosarcoma Undergoing Surgery180
(8 participants)
Gliosarcoma; Recurrent Glioblastoma
Selected Study Details Arms and Interventions Brief description and Outcome Measures
Official Study Title:
A Phase 0 First-In-Human Study Using NU-0129: A Spherical Nucleic Acid (SNA) Gold Nanoparticle Targeting BCL2L12 in Recurrent Glioblastoma Multiforme or Gliosarcoma Patients
Study Phase: Phase 0
Study Objectives:
PRIMARY OBJECTIVES:
 I. To assess the safety of i.v. administration of NU-0129
SECONDARY OBJECTIVES:
 I. To assess serum drug concentration
 II. To verify intratumoral penetration of NU-0129.
 III. To verify the feasibility of administering NU-0129 as a standard treatment for recurrent glioblastoma multiforme or gliosarcoma.
TERTIARY OBJECTIVES:
 I. To analyze Bcl2L12 expression levels
 II. Progression free survival and overall survival at 6 months; overall response rate.
Study design:
Interventional, Open Label, Single Group Assignment
Study dates: Study start date: May 25, 2017; Study end date: August 19, 2020
Study Status: completed		 Arms:
1. Experimental treatment (NU-0129)

Intervention:
1. Laboratory Biomarker Analysis
2. Pharmacological Study		 Brief Summary:
The aim of this study is to evaluate the safety of the administered drug, NU-0129, (via application of nucleic acids arranged on the surface of a small spherical gold nanoparticle) in patients with recurrent glioblastoma multiforme or gliosarcoma. The researchers expect that targeting the Bcl2L12 gene with NU-0129 will stop cancer cells from growing.

Primary Outcome Measures
Incidence of Adverse Events
Secondary Outcome Measures
1. Drug concentration in blood
2. Biodistribution of NU-0129 in tumor tissue (concentration of particles in various parts of the tumors).
3. Feasibility of administering NU-0129 as a standard treatment