Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Candel Therapeutics, Inc.
Study ID
NCT01997190
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AdV-tk + valacyclovir — BIOLOGICAL
    AdV-tk will be administered intrapleural through pleural catheter followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each AdV-tk administration.

Study Details

This is a phase I study of intrapleural AdV-tk therapy in patients with malignant pleural effusion (MPE). The primary objective is to test the safety of intrapleural AdV-tk therapy. Secondary objectives are to evaluate clinical efficacy and biologic activity

Key Dates

Start date
Oct 31, 2013
Status verified
Aug 2023
Primary completion
Dec 31, 2015
Completion
Feb 28, 2018

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Arm
    AdV-tk + valacyclovir

Primary Outcome Measure

Incidence of treatment emergent adverse events [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
University of Pennsylvania· Philadelphia, PA

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