Status:
COMPLETED
A Trial to Evaluate the Safety of Intratumoral VCL-IM01 Followed by Electroporation in Metastatic Melanoma
Lead Sponsor:
Vical
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety of intratumorally injected VCL-IM01 at doses of 0.5 mg (1 tumor), 1.5 mg (1 tumor), 5 mg (1 tumor), 10 mg (2 tumors, 5 mg per tumor) and 15 mg (3 tumors, 5 mg per tumor) followe...
Detailed Description
Eligible subjects will receive intratumoral injections of VCL-IM01 followed by electroporation of the injected tumor(s). Subjects will be enrolled to receive one course of treatment. A course of trea...
Eligibility Criteria
Inclusion
- Inclusion Criteria - Key criteria include:
- Confirmed recurrent metastatic melanoma
- Tumor(s) to be treated must be at least 1 cm by 1 cm, and be accessible to treatment
- Able to carry out normal daily activities and light work without assistance
- Not currently receiving chemotherapy or immunotherapy
- Normal blood chemistries and blood cell counts (elevation of LDH to less than or equal to 1.5 times normal is allowed)
- Able and willing to give informed consent.
- Exclusion Criteria - Key criteria include:
- History of brain tumors (resected or stereotactically treated is allowed)
- History of liver tumors
- Subjects whose melanoma can be cured by surgery
- Pregnant
- Subjects with electronic pacemakers, defibrillators, or any other implanted electronic device.
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00223899
Start Date
July 1 2005
End Date
October 1 2008
Last Update
February 27 2019
Active Locations (4)
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1
Location #2
Mobile, Alabama, United States, 36606
2
Location #3
Denver, Colorado, United States, 80045
3
Location #1
Chicago, Illinois, United States, 60068
4
Location #4
Montclair, New Jersey, United States, 07042