MedTrace Logo

GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer

NCT00400517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-08-28

Study results available
· View outcomes & findings →

Summary

RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.

Conditions

Interventions

PROCEDURE

conventional surgery

SOC care surgery

PROCEDURE

neoadjuvant therapy

post radical prostatectomy

BIOLOGICAL

sargramostim

administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day

DRUG

thalidomide

doses up to 400 mg/day

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Jorge Garcia, MD, FACP · The Cleveland Clinic

  • Eric Klein, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00400517 on ClinicalTrials.gov