Phase I/II Trial of the A-dmDT390-bisFv (UCHT1)Fusion Protein in Combination With Ionizing Radiation for the Treatment of Stage IV Melanoma
18 Years
80 Years
Both
Melanoma
Trial Information
Phase I/II Trial of the A-dmDT390-bisFv (UCHT1)Fusion Protein in Combination With Ionizing Radiation for the Treatment of Stage IV Melanoma
Inclusion Criteria:
- All patients must have histologically proven stage IV metastatic melanoma consisting
of at least two lesions
- Patients must have a performance status of < 2 on Eastern Cooperative Oncology Group
scale (see Appendix).
- Patients must have bilirubin < 1.5 mg/dL, transaminases < 2.5 X ULN, albumin > 3
gm/dL, creatinine < 2.0 mg/dL, adequate pulmonary function by physical exam and pulse
oxometry and adequate cardiac reserve (EF > 50% normal). Patients must have a normal
echocardiogram without any evidence of cardiac chamber hypertrophy, dilatation or
hypokinesis.
- Patients must give written informed consent prior to registration.
- Females and males must be willing to use an approved form of birth control while on
this study and for 2 weeks after completion.
- Patients of ages 18-80 are eligible provided they have stage IV melanoma and are
negative for BRAF or have failed BRAF inhibitor treatment or if they have failed or
are intolerant to other established therapy known to provide clinical benefit for
their condition or if they have been adequately consented and agreed to forgo FDA
approved clinically meaningful therapy
Exclusion Criteria:
- Inability to give informed consent because of psychiatric problems, or complicated
medical problems.
- Serious concurrent medical problems, uncontrolled infections, or disseminated
intravascular coagulopathy (DIC).
- Preexisting cardiovascular disease, the only exception being well controlled
essential hypertension with a sitting blood pressure of <155 systolic and <90
diastolic without any evidence of structural heart disease or one episode of
myocardial infarction > 8 months ago. A past history of the any of the following are
exclusions: congestive heart failure, atrial fibrillation, pulmonary hypertension,
anticoagulant drug therapy, thromboembolic events, cardiomyopathy or a myocardial
infarction within the past 8 months.
- Pregnant or nursing women will be excluded from study.
- History of congestive heart failure.
- History of cirrhosis of the liver
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Outcome Measure:
Immune-related overall response rate (irORR)
Outcome Description:
Response will be assessed at 2 months, and at least every 3 months (±7 days) thereafter using for up to 1 year after the last treatment administration or until evidence of disease progression.Tumor measurements and therapeutic response will be determined using irRC (Immune Related Response Criteria). At a minimum, CT scans of the chest, abdomen, and pelvis will be performed at study entry, at 2 months, and, if a response or stable disease, at least every 3 months (±7 days) for up to 1 year after the last dose of study drug, and/or at any time there is clinical evidence of disease progression, to evaluate disease status.
Outcome Time Frame:
For up to 1 year post treatment or until disease progression
Safety Issue:
Yes
Principal Investigator
Jason Chesney, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
James Graham Brown Cancer Center, University of Louisville
Authority:
United States: Food and Drug Administration
Study ID:
BCC-MEL-13
NCT ID:
NCT01888081
Start Date:
Completion Date:
Related Keywords:
- Melanoma
- Melanoma
Name | Location |
|---|---|
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
