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Tests treatment safety and results for Glioma
Official title Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
ClinicalTrials.gov ID: NCT01906385
What this study is testing
What is Rhenium Liposome Treatment?
Rhenium Liposome Treatment is an investigational medicine, being studied as a potential treatment for glioma.
Also referred to as Rhenium-186 NanoLiposome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 36 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years of age.
- 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...
- Histologically confirmed Grade III/IV recurrent Glioma (following 2021 WHO CNS5 glioma nomenclature, e.g., Astrocytoma, IDH-mutant grade 3 or 4...
- Progression by RANO criteria or other clinically accepted neurooncology evaluation, following standard treatment options with known survival benefit...
- Patients who receive treatment with antiepileptic medications must have a two-week history of stable dose of antiepileptic without seizures prior to...
You likely can't join if
- The subject has evidence of acute intracranial or intratumoral hemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT)...
- The subject is unable or contraindicated to undergo MRI scan (e.g., has pacemaker or medically unstable).
- The subject has not recovered to CTCAE v4.0 Grade ≤1 from AEs (except alopecia, anemia, and lymphopenia) due to antineoplastic agents...
- The subject is pregnant or breast-feeding.
- The subject has serious intercurrent illness, as determined by the treating physician, which would compromise either patient safety or study outcomes...
- hypertension (two or more blood pressure readings performed at screening of \>150 mmHg systolic or \>100 mmHg diastolic) despite optimal treatment
See the full eligibility criteria
Who can join
- At least 18 years of age.
- 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.
- Histologically confirmed Grade III/IV recurrent Glioma (following 2021 WHO CNS5 glioma nomenclature, e.g., Astrocytoma, IDH-mutant grade 3 or 4; Glioblastoma, IDH-wildtype grade 4).
- Progression by RANO criteria or other clinically accepted neurooncology evaluation, following standard treatment options with known survival benefit for any recurrence (e.g., surgery, temozolomide, radiation, and tumor...
- Patients who receive treatment with antiepileptic medications must have a two-week history of stable dose of antiepileptic without seizures prior to study start (dosing).
- 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 prior to study start (dosing).
- Patients with Grade III/IV Glioma (following 2021 WHO CNS5 glioma nomenclature, e.g., Astrocytoma, IDH-mutant grade 3 or 4; Glioblastoma, IDH-wildtype grade 4) which falls within the treatment field volume.
- ECOG performance status of 0 to 2; Karnofsky Performance Status ≥ 60.
- Life expectancy of at least 2 months.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN)
- Acceptable renal function: a. Serum creatinine ≤1.5xULN
- Acceptable hematologic status (without hematologic support):
- ANC ≥1000 cells/uL
- Platelet count ≥100,000/uL
- Hemoglobin ≥9.0 g/dL
- All women of childbearing potential must have a negative serum pregnancy test and male and female people must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier...
What rules you out
- The subject has evidence of acute intracranial or intratumoral hemorrhage either by magnetic resonance imaging (MRI) or computerized tomography (CT) scan. people with resolving hemorrhage changes, punctate hemorrhage...
- The subject is unable or contraindicated to undergo MRI scan (e.g., has pacemaker or medically unstable).
- The subject has not recovered to CTCAE v4.0 Grade ≤1 from AEs (except alopecia, anemia, and lymphopenia) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study.
- The subject is pregnant or breast-feeding.
- The subject has serious intercurrent illness, as determined by the treating physician, which 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
- active medically significant infection unresponsive to antibiotics (e.g., non- healing wound, ulcer), uncontrolled systemic infection, or bone fracture
- clinically significant cardiac arrhythmias not controlled by appropriate medications
- untreated hypothyroidism
- symptomatic congestive heart failure or unstable angina pectoris within 3 months prior to study drug
- myocardial infarction, stroke, or transient ischemic attack within 6 months prior to study drug
- known active malignancy (other than glioma) except non-melanoma skin cancer or carcinoma in-situ in the cervix unless PI determines it would not impact patient safety or how well it works determinations
- The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- The subject has received any of the following prior anticancer therapy:
- Prior treatment with Bevacizumab
- 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 (e.g., tamoxifen) within 14 days or 5 half-lives, whichever is shorter, prior to study start...
- Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to study start (dosing)
- 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 study start (dosing)
- Prior treatment with carmustine wafers
- Patients who are currently receiving any other investigational agents and/or who have received an investigational agent in 28 days prior to study start (dosing)
- Multifocal progression or involvement of the leptomeninges.
- Psychiatric illness/social situations that would limit compliance with the study requirements
- Infratentorial disease
- The subject has a tumor located within 1-2 cm of a ventricle AND it is determined by the surgeon, PI, and sponsor to be a risk for drug extravasation to the subarachnoid space if given catheter placement and drug...
- Phase 2 only: The subject should have a tumor volume of ≤20 cm3 to be included in the Phase 2 portion of the study. people with tumor volumes of greater than 20 cm3 are excluded from the Phase 2 portion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Manhasset, New York, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manhasset, New York, United States; Dallas, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.