D2C7-IT for Malignant Glioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Malignant GliomaD2C7-IT - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug combination for brain cancer.

Eligible Conditions
  • Malignant Glioma

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 28 days after catheter removal

Day 28
Proportion of patients with dose-limiting toxicity (DLT) within each dose level

Trial Safety

Trial Design

1 Treatment Group

D2C7-IT + 2141-V11
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: D2C7-IT · No Placebo Group · Phase 1

D2C7-IT + 2141-V11Experimental Group · 2 Interventions: 2141-V11, D2C7-IT · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 28 days after catheter removal

Who is running the clinical trial?

Rockefeller UniversityOTHER
151 Previous Clinical Trials
16,953 Total Patients Enrolled
Darell BignerLead Sponsor
4 Previous Clinical Trials
99 Total Patients Enrolled
Daniel Landi, MDPrincipal InvestigatorDuke University
7 Previous Clinical Trials
227 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who have a high grade glioma with molecular features of glioblastoma will be eligible to participate in this study
People who are not sexually active, who are physiologically incapable of becoming pregnant, who have had a vasectomy, or who are post-menopausal are considered non-childbearing potential
You must be at least eighteen years old to join this study.
is considered excellent If someone's Karnofsky Performance Score is 70% or higher, then their performance is considered excellent.
The patient must have a platelet count of at least 100,000/uL to be eligible for the study; however, to undergo a biopsy and catheter insertion, the patient must have a platelet count of at least 125,000/uL, which can be attained with the help of platelet transfusion.
was predictive of better prognosis The text says that a high neutrophil count prior to a biopsy is predictive of a better prognosis.
The creatinine level is below the normal range before the biopsy.
A person with a total bilirubin level of less than 1.5 times the upper limit of normal is allowed to have a liver biopsy, with the exception of someone who has known or suspected Gilbert's Syndrome, in which case a total bilirubin level of less than 3.0 times the upper limit of normal is allowed.
The following text states that Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels should be ≤ 2.5 x the upper limit of normal (ULN).