MedTrace Logo

PR104 and G-CSF in Treating Patients With Solid Tumors

NCT00616213 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2011-06-01

No results posted yet for this study

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.

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

BIOLOGICAL

filgrastim

filgrastim will be administered at a standard dose and schedule

DRUG

PR104

PR104 is administered intravenously once every 21 days

OTHER

F-18-fluoromisonidazole

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

Sponsors & Collaborators

  • Proacta, Incorporated

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-09-30
Completion
2009-06-30

Countries

  • United States
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00616213 on ClinicalTrials.gov