NCT00616213

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2008

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

Enrollment Period

7 months

First QC Date

February 14, 2008

Last Update Submit

May 31, 2011

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of PR-104

    3 weeks (cycle 1)

Secondary Outcomes (5)

  • Safety profile using CTCAE v3 criteria

  • Dose-limiting toxicity of PR-104

  • Pharmacokinetics of PR-104 and its alcohol metabolite in blood

  • Anti-tumor activity

  • Biomarkers of tumor hypoxia

Interventions

filgrastimBIOLOGICAL

filgrastim will be administered at a standard dose and schedule

Also known as: Neupogen, G-CSF
PR104DRUG

PR104 is administered intravenously once every 21 days

Also known as: PR-104
F-18-fluoromisonidazoleOTHER

F-18-fluoromisonidazole is administered intravenously prior to performance of PET scan

Also known as: FMISO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85258-4512, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

Waikato Hospital

Hamilton, 2020, New Zealand

Location

MeSH Terms

Interventions

FilgrastimGranulocyte Colony-Stimulating FactorPR-104fluoromisonidazole

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 15, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2008

Study Completion

June 1, 2009

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

NZ(1)US(2)