CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT01881867 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-07-09

Study results available
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Summary

This randomized phase II trial studies how well glycosylated recombinant human interleukin-7 (CYT107) after vaccine therapy works in treating patients with castration-resistant prostate cancer that has spread to other areas of the body or has not responded to at least one type of treatment. Biological therapies, such as glycosylated recombinant human interleukin-7, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. It is not yet known whether glycosylated recombinant human interleukin-7 works better with or without vaccine therapy in treating prostate cancer.

Conditions

  • Castration Levels of Testosterone
  • Castration-Resistant Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Stage IV Prostate Cancer

Interventions

BIOLOGICAL

Glycosylated Recombinant Human Interleukin-7

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • Cancer Immunotherapy Trials Network

    collaborator NETWORK
  • National Cancer Institute (NCI)

    collaborator NIH
  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Lawrence Fong · Cancer Immunotherapy Trials Network

  • Martin A. Cheever · Fred Hutchinson Cancer Research Center/Cancer Immunotherapy Trials Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-10
Primary Completion
2017-05-15
Completion
2018-01-02

Countries

  • United States

Study Locations

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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 NCT01881867 on ClinicalTrials.gov