NCT01888081

Brief Summary

The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable with median overall survival periods that range from 8-16 months.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

6.8 years

First QC Date

June 21, 2013

Last Update Submit

November 22, 2016

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • Immune-related overall response rate (irORR)

    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.

    For up to 1 year post treatment or until disease progression

Secondary Outcomes (1)

  • Overall survival

    every 3 months for up to 3 years

Other Outcomes (1)

  • Treatment Duration

    4 Days

Study Arms (1)

A-dmDT390-bisFv(UCHT1) with Ionizing Radiation

EXPERIMENTAL

A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation

Drug: A-dmDT390-bisFv(UCHT1) (Resimmune®)Radiation: Ionizing Radiation

Interventions

A-dmDT390-bisFv(UCHT1) (Resimmune®)DRUG
A-dmDT390-bisFv(UCHT1) with Ionizing Radiation
Ionizing RadiationRADIATION
A-dmDT390-bisFv(UCHT1) with Ionizing Radiation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 oximetry 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

You may not qualify if:

  • Inability to give informed consent because of psychiatric problems, or complicated medical problems.
  • Serious concurrent medical problems, uncontrolled infections, or disseminated intravascular coagulopathy (DIC).
  • Pregnant or nursing women will be excluded from study.
  • History of congestive heart failure.
  • History of cirrhosis of the liver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Radiation, Ionizing

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiationPhysical Phenomena

Study Officials

  • Jason Chesney, MD, PhD

    James Graham Brown Cancer Center, University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 27, 2013

Study Start

February 1, 2014

Primary Completion

December 1, 2020

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

US(1)