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Trial record 1 of 1 for:    NCT01906385
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Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)

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ClinicalTrials.gov Identifier: NCT01906385
Recruitment Status : Recruiting
First Posted : July 24, 2013
Last Update Posted : July 13, 2022
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Plus Therapeutics

Brief Summary:
This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.

Condition or disease Intervention/treatment Phase
Glioma Drug: Rhenium Liposome Treatment Phase 1 Phase 2

Detailed Description:

This Phase I clinical study evaluates a single dose of 186RNL (radionuclide clinical study drug) administered through a convection enhanced delivery catheter (CED catheter) in participants with recurrent Glioma (GBM).

The clinical study treatment consists of a single administered dose of 186RNL per participant.

The clinical study will include the evaluation of multiple separate dose levels (dose escalation). Three to six participants may be treated at each dose.

The maximum number of participants to be enrolled in the study is approximately 55.

The clinical study treatment will be administered, following CED placement, by the clinical study physician.

Participants will be followed for up to 12 months after the clinical study drug is administered.

The U.S. Food and Drug Administration (FDA) has not approved 186RNL for this specific disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dual Phase 1/2 Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of 186Rhenium Nanoliposomes (186RNL) in Recurrent Glioma (CTRC# 12-02)
Actual Study Start Date : June 3, 2015
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Rhenium Liposome Treatment

Arm Experimental: Dose Escalation for Cohorts 1-8 Each participant will receive a single administration of 186RNL. At each dose level, a minimum of three to a maximum of six participants will be enrolled.

If no dose limiting toxicity is observed in the initial three participants, then the then the next higher dose level cohort will open for enrollment.

The dose escalation scheme will follow a modified Fibonacci dose escalation scheme as shown below:

COHORT ACTIVITY Cohort 1 (1.0 mCi) Cohort 2 (2.0 mCi) Cohort 3 (4.0 mCi) Cohort 4 (8.0 mCi) Cohort 5 (13.4 mCi) Cohort 6 (22.3 mCi) Cohort 7 (31.2 mCi) Cohort 8 (41.5 mCi)

Drug: Rhenium Liposome Treatment
At the time of stereotactic biopsy a catheter will be placed within the tumor using stereotactic guidance. Once the patient has adequately recovered from the procedure as determined by the neurosurgeon, 186RNL will be infused through the CED catheter at the predetermined dose. Spectroscopic imaging will then be obtained at predefined time points to visualize the distribution of the 186RNL as well as calculated the actual dose retained within the tumor. Patients will be monitored longitudinally for evidence of toxicity and response by MRI.
Other Name: Rhenium-186 NanoLiposome

Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 90 days ]
    Evaluation of any toxicity associated with research treatment per Common Toxicity Criteria for Adverse Events.

Secondary Outcome Measures :
  1. Dose Distribution [ Time Frame: 3 days ]
    SPECT imaging of the radioactive materials spread across the tumor and surrounding brain

  2. Response rate [ Time Frame: 90 days ]
    Evaluation of overall response rate by RANO criteria

  3. Survival [ Time Frame: 6 months ]
    Disease specific progression free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. At least 18 years of age
  2. 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
  3. Histologically confirmed glioma
  4. Progression by Response Assessment in Neuro-Oncology (RANO) criteria following standard treatment options with known survival benefit (Temozolomide, Radiation, and Tumor Treating Fields [unless unwilling])
  5. Patients who receive treatment with antiepileptic medications must have a two week history of stable dose of antiepileptic without seizures prior to dosing
  6. Patients with corticosteroid requirements to control cerebral edema must be maintained at a stable or decreasing dose for a minimum of two weeks without progression of clinical symptoms
  7. A volume of enhancing tumor which falls within the treatment field volume being evaluated in the respective cohort (see 4.1 Design)
  8. Eastern Cooperative Oncology Group (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 ≥100,000/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

    For part 2:

  14. Bevacizumab naïve glioblastoma with no more than 1 recurrence

Exclusion Criteria:

  1. 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.
  2. The subject is unable to undergo MRI scan (eg, has pacemaker).
  3. 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.
  4. The subject is pregnant or breast-feeding.
  5. The subject has serious intercurrent illness, as determined by the treating physician, that would compromise either patient safety or study outcomes such as:

    • hypertension (two or more blood pressure readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment
    • Non-healing wound, ulcer, or bone fracture
    • Clinically significant cardiac arrhythmias
    • Untreated hypothyroidism
    • Uncontrolled systemic infection
    • Symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug
    • Myocardial infarction, stroke, transient ischemic attack within 6 months
    • Known active malignancy (other than glioma) except non-melanoma skin cancer or carcinoma in-situ in the cervix
  6. The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding
  7. The subject has received any of the following prior anticancer therapy:

    • Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT) to the target site.
    • Radiation therapy within 12 weeks of screening
    • Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 14 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
    • Patients who are currently receiving any other investigational agents and/or who have received an investigational agent in the prior 28 days
  8. Multifocal progression or involvement of the leptomeninges
  9. Psychiatric illness/social situations that would limit compliance with the study requirements
  10. Infratentorial disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906385

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Contact: Erika Butler, MS 210-974-6919 ebutler@plustherapeutics.com
Contact: Norman LaFrance, MD (CMO) 215-808-0955 nlafrance@plustherapeutics.com

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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Omar Raslan    214-648-6691    Omar.Raslan@UTSouthwestern.edu   
Principal Investigator: Toral Patel, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Summer Stovall    713-745-4243    sstovall@mdanderson.org   
Principal Investigator: Jeffrey Weinberg, MD         
The Cancer Therapy and Research Center at UTHSCSA Recruiting
San Antonio, Texas, United States, 78229
Contact: Epp Goodwin    210-450-5798      
Principal Investigator: Andrew J Brenner, M.D., Ph.D.         
Sub-Investigator: John R Floyd, M.D.         
Sub-Investigator: William T Phillips, M.D.         
Sponsors and Collaborators
Plus Therapeutics
National Cancer Institute (NCI)
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Study Chair: Marc Hedrick, MD Plus Therapeutics, President and CEO
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Responsible Party: Plus Therapeutics
ClinicalTrials.gov Identifier: NCT01906385    
Other Study ID Numbers: CTRC 12-02
14-450X ( Other Identifier: UT Health San Antonio )
20141749 ( Other Identifier: WIRB )
1R01CA235800-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Plus Therapeutics:
Brain Tumor
Recurrent Glioblastoma
Rhenium Nanoliposome
Brain Cancer
High Grade Glioma
Glioblastoma Multiform
Grade IV Astrocytoma
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue