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Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01906385
Recruitment Status : Recruiting
First Posted : July 24, 2013
Last Update Posted : July 13, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Plus Therapeutics

Tracking Information
First Submitted Date  ICMJE January 11, 2012
First Posted Date  ICMJE July 24, 2013
Last Update Posted Date July 13, 2020
Actual Study Start Date  ICMJE June 3, 2015
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2013)
Maximum Tolerated Dose [ Time Frame: 90 days ]
Evaluation of any toxicity associated with research treatment per Common Toxicity Criteria for Adverse Events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Dose Distribution [ Time Frame: 3 days ]
    SPECT imaging of the radioactive materials spread across the tumor and surrounding brain
  • Response rate [ Time Frame: 90 days ]
    Evaluation of overall response rate by RANO criteria
  • Survival [ Time Frame: 6 months ]
    Disease specific progression free survival
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2013)
  • Dose Distribution [ Time Frame: 3 days ]
    SPECT imaging of the radioacitve materials spread across the tumor and surrounding brain
  • Response rate [ Time Frame: 90 days ]
    Evaluation of overall response rate by RANO criteria
  • Survival [ Time Frame: 6 months ]
    Disease specific progression free survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioma
Intervention  ICMJE 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 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.
Study Arms  ICMJE Experimental: Rhenium Liposome Treatment
Intervention: Drug: Rhenium Liposome Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
55
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2013)
30
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Epp Goodwin 210-450-5798 goodwine@uthscsa.edu
Contact: Maggie Tomasini 210-450-5962 ctrcreferral@uthscsa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01906385
Other Study ID Numbers  ICMJE CTRC 12-02
14-450X ( Other Identifier: UT Health San Antonio )
20141749 ( Other Identifier: WIRB )
1R01CA235800-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Plus Therapeutics
Study Sponsor  ICMJE Plus Therapeutics
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Andrew J Brenner, MD, PhD The University of Texas Health Science Center at San Antonio
PRS Account Plus Therapeutics
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP