PR104 and G-CSF in Treating Patients With Solid Tumors

May 31, 2011 updated by: Proacta, Incorporated

A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given together with G-CSF in treating patients with solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF) in patients with solid tumors.

Secondary

  • Characterize the safety of this regimen in these patients.
  • Evaluate the pharmacokinetics of PR-104 and its alcohol metabolite.
  • Evaluate the rate of hypoxia in various solid tumors using F-MISO PET (18F-fluoromisonidazole positron emission tomography) imaging.
  • Assess for antitumor toxicity in these patients.
  • Collect plasma samples for the assessment of potential biomarkers of tumor hypoxia.

OUTLINE: This is a multicenter, dose-escalation study of PR-104.

Patients receive PR-104 IV over 1 hour on day 1 and filgrastim (G-CSF) on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo 18F-fluoromisonidazole PET scans at baseline and prior to course 3 to assess tumor hypoxia.

Patients undergo blood sample collection periodically during course 1. Samples are analyzed for the pharmacokinetics of PR-104 and for identification of biomarkers for tumor hypoxia.

After completion of study treatment, patients are followed at 30 days.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Hamilton, New Zealand, 2020
        • Waikato Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258-4512
        • Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumors
  • Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9 g/dL (no red blood cell transfusions allowed)
  • Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • PTT ≤ 1.5 times normal
  • Serum creatinine ≤ 1.5 times ULN
  • ALT or AST ≤ 2 times ULN (≤ 5 times ULN if liver metastases are present)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 30 days after completion of study therapy
  • Able to read, understand, and provide written informed consent

Exclusion criteria:

  • Evidence of a significant medical disorder or laboratory finding that, in the opinion of the investigator, compromises the patient's safety during study participation, including any of the following:

    • Uncontrolled infection or infection requiring a concomitant parenteral antibiotic
    • Uncontrolled diabetes
    • Congestive heart failure
    • Myocardial infarction within the past 6 months
    • Chronic renal disease
    • Coagulopathy (excluding prophylactic anticoagulation)
  • Known HIV positivity
  • Hepatitis B sAg-positive or known to be hepatitis C-positive with abnormal liver function tests

PRIOR CONCURRENT THERAPY:

  • No more than 3 prior myelosuppressive chemotherapy regimens

    • Patients who have received more than 3 prior myelosuppressive regimens may be eligible, if considered to have adequate marrow, based on prior exposure to 1 of the following regimens:

      • Minimally myelosuppressive regimens
      • Limited courses of myelosuppressive regimens
  • More than 4 weeks since prior and no other concurrent licensed or investigational anticancer treatment (6 weeks for nitrosoureas or mitomycin C)
  • More than 24 hours since any prior radiotherapy and no likelihood of toxicity from this therapy
  • More than 4 weeks since major surgery
  • No prior radiotherapy to > 20% of bone marrow
  • No prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplantations)
  • Prior and concurrent androgen deprivation therapy allowed
  • Concurrent systemic steroids allowed, provided the patient has been on a stable dose for at least 2 weeks prior to first dose of PR-104
  • No concurrent irradiation therapy (palliative or therapeutic), unless given in the absence of tumor progression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose of PR-104
Time Frame: 3 weeks (cycle 1)
3 weeks (cycle 1)

Secondary Outcome Measures

Outcome Measure
Anti-tumor activity
Safety profile using CTCAE v3 criteria
Dose-limiting toxicity of PR-104
Pharmacokinetics of PR-104 and its alcohol metabolite in blood
Biomarkers of tumor hypoxia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proacta, Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR104-1004
  • PROACTA-PR-104-1004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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