Maximum Tolerated
Dose, Safety, and
Efficacy of Rhenium
NanoLiposomes in
Recurrent Glioma

 

 Recruiting Patients

Maximum Tolerated
Dose, Safety, and
Efficacy of Rhenium
NanoLiposomes in
Recurrent Glioma

 

 Recruiting Patients

Maximum
Tolerated Dose,
Safety, and
Efficacy of
Rhenium
NanoLiposomes
in Recurrent
Glioma

 

 Recruiting Patients

Trial Information

The purpose of the ReSPECT Clinical Trial is to assess the safety, tolerability, and distribution of a new medication, Rhenium NanoLiposome (RNL™), in adults with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment.  ReSPECT is supported by the National Institutes of Health / National Cancer Institute.

View Trial on ClinicalTrials.gov

NATIONAL TRIAL REFERENCE NUMBER

NCT01906385

When speaking with your physician, please have the national trial reference number available.

Single Group

  • All patients who enroll in the trial will receive medication while on the study.
  • All patients will receive a single treatment of Rhenium NanoLiposome (RNL™).

Phase 1/2

  • Phase 1:  A Phase 1 study of a new medication is usually the first that involves human volunteers who have the disease or condition the investigational medicine is designed to treat.  The primary objective of Phase 1 studies is to identify the highest dose of the new medication that can be safely given without serious side effects.
  • Phase 2:  If a new medication is found to be reasonably safe in a Phase 1 study, it can then be evaluated in a Phase 2 study to determine if it works.  Doctors will assess whether the new medication provides a specific benefit or response, such as tumor shrinkage, improved quality of life, or longer patient survival.

Progress

  • Actual Study Start:  June 3, 2015
  • Estimated Primary Completion:  January 2025 (the date that the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected)
  • Estimated Study Completion:  January 2025 (the date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events, that is, the last participant’s last visit). 

Patient Eligibility

Only a qualified healthcare professional can determine whether or not you are eligible to participate in a clinical trial. However, this information may be beneficial in initiating a conversation with your physician.

Condition

Recurrent or Progressive Malignant Glioma

Age Range

Adults, 18 Years and Older

Gender

All

Principal Investigators

There is a physician who is responsible for the scientific and technical direction of the clinical trial at each location.

Andrew Brenner, M.D., Ph.D.

UT Health San Antonio
Mays Cancer Center

 

 

 

 

SPECIALTIES:  MEDICAL ONCOLOGY, INTERNAL MEDICINE

A specialist in both breast cancer and malignancies of the brain and spinal cord, Andrew Brenner, M.D., Ph.D., not only focuses on clinical management, but also on the development of novel therapies to treat breast cancers and central nervous system tumors.

A graduate of Texas A&M University, he earned his bachelor’s degree in biochemistry and went on to earn his doctorate in biological science and tumor biology at The University of Texas M.D. Anderson Cancer Center – Science Park. His doctoral thesis focused on the role of the cyclin dependent kinase inhibitor p16INK4a in mammary tumorigenesis and immortilization. Dr. Brenner’s current interests have transitioned from cell cycle to the effect of hypoxia on chemokines and escape from antiangiogenics and the role of obesity in promoting breast tumorigenesis.

Dr. Brenner received his medical degree from the Texas Tech University Health Science Center and completed a residency in internal medicine at Scott and White Hospital in Lubbock. He completed his fellowship in hematology and medical oncology at the UT Health San Antonio.

Toral Patel, M.D.

UT Southwestern Medical Center
Peter O’Donnell Jr. Brain Institute

 

 

 

 

SPECIALTIES:  NEUROLOGICAL SURGERY, SKULL BASE TUMORS, NEUROLOGICAL DISORDERS

Toral Patel, M.D., is an Assistant Professor in UT Southwestern Medical Center’s nationally ranked Department of Neurological Surgery, where she specializes in brain tumor surgery.

Dr. Patel received her undergraduate degree in biomedical engineering from Johns Hopkins University and earned her medical degree at UT Southwestern Medical School. She completed an internship in general surgery at Yale-New Haven Hospital, followed by a residency in neurological surgery, serving as Chief Resident. She then received advanced training in neurosurgical oncology through a fellowship at Memorial Sloan Kettering Cancer Center before returning to UT Southwestern as a faculty member in 2014.

Dr. Patel’s research has garnered numerous awards, including the William F. Collins Resident Research Award, a Seed Grant from the American Medical Association, the UT Southwestern Medical Student Summer Research Award, the Louis E. Goodman Award, and the Johns Hopkins University Department of Biomedical Engineering Undergraduate Research Award. She currently holds a patent titled “Highly penetrative nanocarriers for treatment of CNS disease” for her research into how nanoparticles can be used to carry drugs directly to the site of brain tumors.

Dr. Patel is a member of the Society for Neuro-Oncology, the American Medical Association, the American College of Surgeons, the Congress of Neurological Surgeons, and the American Association of Neurological Surgeons.

She was included in D Magazine‘s Best Doctors list for 2018.

Trial Locations

There are currently 2 clinical trial locations in the United States that are enrolling patients:

  1. UT Health Science Center San Antonio
  2. UT Southwestern Medical Center in Dallas

Please visit this website regularly for updates as new locations are added.

Patients Treated to Date

What Can You Do Next?

Participating in a clinical trial is an important decision.  If you believe this clinical trial might be a good fit and are interested in participating, please take the next step to see if you are eligible.

Discuss With Your Physician

Anyone participating in a clinical trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll.  If you are interested in participating in a clinical trial, please talk to your physician first.

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Print, save, or email this page to your physician to discuss at your next visit.

Be sure to have National Trial Reference Number NCT01906385 available.

Contact A Trial Coordinator

A trial coordinator is a specialized researcher who supports the management and coordination of clinical research studies.  If you are interested in participating in a clinical trial, you may call a trial coordinator directly at one of the trial locations below.

UT Health Science Center
San Antonio

Epp Goodwin
210-450-5798
goodwine@uthscsa.edu

UT Southwestern Medical Center
Dallas

Shanda Grant, RRT MHA CCRP
214-648-5874
shanda.grant@UTSouthwestern.edu

Zorica Simic, MS
214-648-5521
zorica.simic@UTSouthwestern.edu

UT MD Anderson Cancer Center
Houston

Not yet recruiting

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