Know Cancer

or
forgot password

Phase I, Open-label Study Evaluating the Safety of Escalating Doses of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally With Co-administration of Fludarabine Phosphate Intravenously) in Subjects With Advanced Solid Tumors


Phase 1
19 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Advanced Solid Tumors

Thank you

Trial Information

Phase I, Open-label Study Evaluating the Safety of Escalating Doses of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally With Co-administration of Fludarabine Phosphate Intravenously) in Subjects With Advanced Solid Tumors


For this first study, we will inject the PNP-loaded adenovirus into the tumors of patients
with cancers primarily in the throat and neck and then give them the drug. This study is
designed with two goals in mind: 1) assessing the overall safety of this approach for the
patient; and 2) observing the effects of this anti-cancer strategy on the tumor itself.
This will be accomplished in two parts. First, we will introduce a modest, fixed amount of
the gene-carrying adenovirus into the tumors of three separate groups of patients and then
administer small, increasingly strong amounts of the fludarabine phosphate to each
successive group over a three-day period. Even in the group that will receive the highest
amount of fludarabine, the total amount given to any individual patient over those three
days will be significantly less than the dose approved by the FDA for patients with
non-solid tumors. Finally, a more concentrated amount of the adenovirus (approximately 10
times more viruses) will be given to a fourth group of patients who will also receive the
highest dose of the drug that was shown to be well tolerated in the prior three groups (the
highest dose at which no serious problems were observed).


Inclusion Criteria:



- Biopsy confirmed diagnosis of a solid tumor

- Failed or exhausted all standard or approved treatment options that would provide
substantive palliation

- Have at least one measurable primary or metastatic tumor on imaging studies or
physical exam whose potential reduction could provide relief of symptoms or benefit

- Tumor is accessible for direct intratumoral injection

Exclusion Criteria:

- Diagnosis of leukemia

- Have previously received any gene therapy products or oncolytic viral therapy

- Receiving treatment with allopurinol

- Received radiation treatment < 4 wks prior to first injection of Ad/PNP

- Received chemotherapy < 4 wks prior to first injection of Ad/PNP

- Have signs or symptoms of active infection

- Receiving chronic systemic corticosteroids or any chronic immunosuppressive
medications within 14 days prior to first injection of Ad/PNP. Subjects receiving
short courses of corticosteroids are considered eligible.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluation of the safety of Ad/PNP-F-araAMP

Outcome Description:

The number of subjects with adverse events as a measure of safety across the 4 dose cohorts.

Outcome Time Frame:

Entry through Study Day 56

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

PNP-001

NCT ID:

NCT01310179

Start Date:

February 2011

Completion Date:

November 2013

Related Keywords:

  • Head and Neck Cancer
  • Advanced Solid Tumors
  • gene therapy
  • advanced solid tumors
  • Head and Neck cancer
  • intratumoral therapy
  • Head and Neck Neoplasms
  • Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Alabama at BirminghamBirmingham, Alabama  35294-3300