NCT01123304

Brief Summary

This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2010

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

Study Start

First participant enrolled

May 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

May 12, 2010

Last Update Submit

July 16, 2014

Conditions

Melanoma

Keywords

melanoma

Outcome Measures

Primary Outcomes (1)

  • Safety of multiple intralesional administration of MORAb-028

    After each patient completes study treatment the patient is evaluated for dose limiting toxicities (DLTs) up to 1 week after their last dose (at day 33)

    Day 33

Secondary Outcomes (1)

  • Maximum tolerated dose of intralesional administration of MORAb-028

    22 months

Study Arms (1)

MORAb 028

EXPERIMENTAL
Drug: MORAb028

Interventions

MORAb028DRUG

1 mg MORAb-028 will be injected at either 1 mg/cm3 per day over 5 days for a total dose of 5 mg for the first cohort and 2 mg/cm3 for the second cohort. Subjects will receive MORAb-028 injections on Days: 1-5, 8-12 and 22-26.

MORAb 028

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules)
  • Tumor accessible to intra-tumoral injections
  • Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3

You may not qualify if:

  • Are candidates for curative surgical excision or lymphadenectomy
  • Prior non-surgical treatment within 4 weeks
  • Known central nervous system (CNS) tumor involvement or metastases
  • Hypersensitivity to MORAb-028

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Melanoma

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

Study Officials

  • Bruce Wallin, MD

    Morphotek

    STUDY DIRECTOR

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

May 12, 2010

First Posted

May 14, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 17, 2014

Record last verified: 2014-07

Locations

US(1)