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New treatment option for IDH1 wt Allele
Official title MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma
ClinicalTrials.gov ID: NCT03896568
What this study is testing
What is Oncolytic Adenovirus Ad5-DNX-2401?
Oncolytic Adenovirus Ad5-DNX-2401 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for idh1 wt allele.
Also referred to as Ad5-Delta24RGD, DNX-2401.
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 phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold).
- Phase 1: an early, usually small safety study
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
- people must meet the following to be eligible and enroll:
- people must be willing and able to provide informed consent, undergo and comply with all study assessments, and adhere to the protocol schedule.
- Patients with recurrent malignant GBM or gliosarcoma will be eligible. Patients with recurrent anaplastic astrocytoma with wild-type IDH-1 gene will...
- Patients must show unequivocal evidence for tumor recurrence or progression by MRI scan after failing prior surgical resection, biopsy, chemotherapy...
- Male or female patients ≥ 18 years of age.
You likely can't join if
- Histology other than GBM, gliosarcoma, IDH wild-type astrocytoma grade III or IDH-mutant astrocytoma grade 4.
- Tumor foci detected below the tentorium or beyond the cranial vault.
- Tumor within the posterior fossa.
- Tumor with leptomeningeal spread.
- Difficulty in obtaining vascular access for percutaneous procedure.
- Ipsilateral carotid stenosis (\>50%, by Doppler studies).
See the full eligibility criteria
Who can join
- people must meet the following to be eligible and enroll:
- people must be willing and able to provide informed consent, undergo and comply with all study assessments, and adhere to the protocol schedule.
- Patients with recurrent malignant GBM or gliosarcoma will be eligible. Patients with recurrent anaplastic astrocytoma with wild-type IDH-1 gene will also be eligible if there is a significant enhancing mass on MRI (≥1.0...
- Patients must show unequivocal evidence for tumor recurrence or progression by MRI scan after failing prior surgical resection, biopsy, chemotherapy or radiation. A baseline MRI must be performed within 24 days prior to...
- Male or female patients ≥ 18 years of age.
- Patients must be able to undergo endovascular treatment based on Doppler studies showing ICA that is less than 50% occluded.
- For patients undergoing resection for biological endpoints, tumors must be surgically resectable at the time of baseline evaluation and craniotomy for tumor resection is indicated as part of their standard medical care.
- Tumors must be ≥1.0 cm in diameter with upper limit of 5 cm maximal diameter.
- Patients must have a Karnofsky performance score ≥ 70.
- Patients must have a life expectancy of at least 16 weeks.
- Patients must have adequate bone marrow function (absolute granulocyte count \> 1,500 and platelet count of \> 75,000), adequate liver function (SGPT and SGOT and bilirubin \< 2 times institutional normal ranges), and...
- Prothrombin time/international normalized ratio (PT/INR) or partial thromboplastin time (PTT) ≤ 1.5x ULN.
- people who have received the following chemotherapies must have completed them within the following time periods prior to Baseline/Day 0 of hMSC-DNX2401 delivery with recovery from any drug-related toxic effects to...
- Four weeks from cytotoxic agents (3 weeks from procarbazine or Temozolomide, 2 weeks from vincristine)
- 6 weeks from nitrosoureas (CCNU, BCNU)
- Four weeks from any targeted investigational agent
- One week from non-cytotoxic agents
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender.
- No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows:
- American Indian or Alaskan Native - 0
- Asian or Pacific Islander - \<2%
- Black, not of Hispanic Origin - 3%
- Hispanic - 6%
- White, not of Hispanic Origin - 88%
- Other or Unknown - 2%
- Total - 100%
- Patients must be 8 weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the...
- Patients must be willing to forego other cytotoxic and non-cytotoxic drug or radiation therapy against the tumor while enrolled in the study.
- Women of childbearing potential must have a negative urine or serum pregnancy test at screening.
- people and their partners must be willing to use effective birth control during the study and for up to 6 months following administration of hMSC-DNX2401. Birth control that is acceptable to use in this study:
- Using twice the normal protection of birth control (i.e., double-barrier) by using a condom AND spermicidal jelly or foam, or a diaphragm AND spermicidal jelly or foam. A spermicidal jelly or foam must be used in...
- Birth control pills ("The Pill")
- Depot or injectable birth control
- IUD (Intrauterine Device)
- Birth Control Patch (e.g., Othro Evra®)
- NuvaRing®
- Surgical sterilization (i.e., tubal ligation or hysterectomy for women or vasectomy for men)
What rules you out
- Histology other than GBM, gliosarcoma, IDH wild-type astrocytoma grade III or IDH-mutant astrocytoma grade 4.
- Tumor foci detected below the tentorium or beyond the cranial vault.
- Tumor within the posterior fossa.
- Tumor with leptomeningeal spread.
- Difficulty in obtaining vascular access for percutaneous procedure.
- Ipsilateral carotid stenosis (\>50%, by Doppler studies).
- Thrombophilias or primary hematological diseases.
- Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions \< 28 days prior to Baseline/Day 0/hMSC-DNX2401 administration.
- Biologic/immunotherapy within 2 weeks of baseline.
- Clinical or laboratory evidence of inflammatory and/or autoimmune disorders.
- Any contraindication for undergoing MRI such as: individuals with pacemakers, epicardial pacer wires, infusion pumps, surgical and/or aneurysm clips, shrapnel, metal prosthesis, implants with potential magnetic...
- Pregnant or nursing females.
- Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions. All people must be afebrile (i.e., \<38.0° Celsius [C]).
- Any medical condition that precludes surgery or endovascular treatment
- Alcoholism (dependency), alcohol or substance abuse within twelve (12) months prior to screening that has caused health consequences.
- Immunocompromised people or those with autoimmune conditions, active hepatitis (Liver function tests \> 2x normal) or human immunodeficiency virus (HIV) seropositivity.
- Evidence of bleeding diathesis or use of anticoagulant medication or any medication that may increase the risk of bleeding that cannot be stopped prior to surgery. If the medication can be discontinued prior to DNX-2401...
- History or current diagnosis of any medical or psychological condition that in the Investigator's opinion might interfere with the subject's ability to participate or inability to obtain informed consent because of...
- Encephalitis, multiple sclerosis or other central nervous system (CNS) infection or primary CNS disease that would interfere with subject evaluation.
- people with known Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.
- people with significant systemic or major illnesses including but not limited to: congestive heart failure, ischemic heart disease, cerebrovascular disease (history of strokes or TIAs in large vessel or small vessel...
- Enrollment in a concomitant therapeutic clinical study.
- Any condition that prevents compliance with the protocol or adherence to therapy.
- For patients enrolled in the biological endpoint phase of the study, patients will be excluded if in the assessment of the surgeon, after resecting the tumor, there is high likelihood of injecting BM-hMSC-DNX2401 into...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Houston, 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.