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A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Pleural Mesothelioma

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Trial Information

A Pilot Study of Repeated Dose Intrapleural Adenoviral-Mediated Interferon-Alpha (SCH 721015, Ad.hIFN-a2b) Gene Transfer for Malignant Pleural Mesothelioma


Ad.hIFN-α (SCH 721015, adenoviral-mediated interferon alpha) is a replication-defective
recombinant adenoviral vector containing the human interferon-alpha (hIFN-alpha) gene. This
Phase I study is designed to evaluate the safety and maximum tolerated dose (MTD) of two
doses of Ad.hIFN-alpha injected into the pleural (intrapleural, IP) and given 4 days apart
in subjects with pleural mesothelioma.

Subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first
dose. Subjects are then admitted to the research center on Days 1 and 4 for dosing and
overnight observation. Subjects are then followed-up as outpatients for a total of 6
months. Radiographic evaluations are repeated on Day 64 and at 6 months. The pleural
catheter is removed once it is not necessary.


Inclusion Criteria:



- evidence of progressive disease after standard first line treatment of mesothelioma;
OR patient has refused standard first line treatment of mesothelioma

- evaluable disease

- No radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic
agents within 14 days prior to infusion of the IFN-α vector

- Must have a pleural space involved with tumor accessible for pleural catheter
insertion

- FEV1> 1 liter or 40% of predicted value

- Must have an anti-adenoviral neutralizing antibody titer equal to or less than
1:1000. This will be measured by the Penn Vector Core

Exclusion Criteria:

- Presence of HIV or Hepatitis B infection

- Use of concurrent systemic steroids, immunosuppressives, or any other medications
that can directly or indirectly suppress the immune system

- Presence of any other life-threatening illness, such as unstable angina, severe
oxygen dependence, significant chronic obstructive pulmonary disease (COPD), end
stage liver or renal disease

- Presence of untreated brain metastases

- Prior bone marrow or stem cell transplants

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To analyze gene transfer with two does separated by three-day interval

Outcome Time Frame:

After the first dose and at each visit until day 94

Safety Issue:

No

Principal Investigator

Daniel H Sterman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

UPCC 18508

NCT ID:

NCT01212367

Start Date:

February 2009

Completion Date:

December 2027

Related Keywords:

  • Malignant Pleural Mesothelioma
  • Gene transfer
  • Immunology
  • Cancer
  • Mesothelioma

Name

Location

University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104