Intrapleural AdV-tk Therapy in Patients With Malignant Pleural Effusion

NCT01997190 | Completed Phase 1 DMC

• 1 other identifier: MpeTK01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Pleural Effusion; Lung Cancer; Mesothelioma; Breast Cancer; Ovarian Cancer

Keywords

Immunotherapy; Gene therapy; Tumor vaccine

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events

  8 weeks

Secondary Outcomes (2)

• Progression-free survival

  5 years

• Overall survival

  10 years

Study Arms (1)

Study Arm

EXPERIMENTAL

AdV-tk + valacyclovir

Biological: AdV-tk + valacyclovir

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 Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have MPE (defined as positive pleural fluid cytology). Eligible patients include NSCLC, small cell lung cancer, malignant mesothelioma (MM), breast cancer and ovarian cancer. Diagnosis must be made prior to AdV-tk injection. For patients with MM, histologic proof is needed, but positive pleural fluid cytology is not required.
• Patients must have an indication for placement of pleural catheter
• Patients must be 18 years of age or older
• Performance status must be ECOG 0-1
• Acute toxic effects from any prior radiotherapy, chemotherapy, or prior surgical procedures must have resolved to NCI CTCAE v 4.0 grade ≤ 1
• Baseline pulmonary function tests must be FEV1 ≥1 liter or 40% of predicted value (may be post-drainage and/or bronchodilator)
• Bilirubin ≤ 1.5 x upper limit of normal (ULN) and ALT, AST and alkaline phosphatase ≤ 2 x ULN
• Serum creatinine \< 2 mg/dl and calculated creatinine clearance \> 30 ml/min
• Hemoglobin ≥ 9 g/dL, ANC \> 1000/mm3 and platelets \> 100,000/mm3
• Serum albumin level ≥ 2.5 g/dL
• Patients must give study specific informed consent prior to enrollment

You may not qualify if:

• Patients may not be on systemic corticosteroids (\>10 mg prednisone per day) or other systemic immunosuppressive drugs
• Patient is not known to be HIV+
• Patient is not pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy.
• Patient may not have clinically significant pericardial effusion
• Patient may not have other serious co-morbid illness or compromised organ function
• Patient may not have liver disease including known cirrhosis, active hepatitis or chronic active hepatitis B
• No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib, aspirin or other NSAIDs
• No concurrent use of other NSAID or aspirin exceeding 100mg/day during celecoxib administration. No wash-out period required.

Sponsors & Collaborators

• Candel Therapeutics, Inc.: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Aggarwal C, Haas AR, Metzger S, Aguilar LK, Aguilar-Cordova E, Manzanera AG, Gomez-Hernandez G, Katz SI, Alley EW, Evans TL, Bauml JM, Cohen RB, Langer CJ, Albelda SM, Sterman DH. Phase I Study of Intrapleural Gene-Mediated Cytotoxic Immunotherapy in Patients with Malignant Pleural Effusion. Mol Ther. 2018 May 2;26(5):1198-1205. doi: 10.1016/j.ymthe.2018.02.015. Epub 2018 Feb 21.

  PMID: 29550074 RESULT

Related Links

• Phase I Study of Intrapleural Gene-Mediated Cytotoxic Immunotherapy in Patients with Malignant Pleural Effusion

MeSH Terms

Conditions

Pleural Effusion, Malignant; Lung Neoplasms; Mesothelioma; Breast Neoplasms; Ovarian Neoplasms

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Lung Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Charu Aggarwal, MD

  University of Pennsylvania

  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: November 19, 2013
• First Posted: November 28, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2018
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)