Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

MUC1 Vaccine in Conjunction With Poly-ICLC in Patients With Recurrent and/or Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00374049
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Oncovir, Inc.
Information provided by (Responsible Party):
Olivera Finn, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 7, 2006
First Posted Date  ICMJE September 8, 2006
Last Update Posted Date July 12, 2016
Study Start Date  ICMJE June 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Proportion of patients showing an immunologic response at week 8 [ Time Frame: 8weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
Proportion of patients showing an immunologic response at week 8
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
  • Measures of systemic immunosuppression [ Time Frame: 8weeks ]
  • Dendritic cell (DC) status [ Time Frame: 7 weeks ]
  • T cell subset analyses [ Time Frame: 8weeks ]
  • Clinical Response [ Time Frame: weekly ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
  • Measures of systemic immunosuppression
  • Dendritic cell (DC) status
  • T cell subset analyses
  • Clinical Response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MUC1 Vaccine in Conjunction With Poly-ICLC in Patients With Recurrent and/or Advanced Prostate Cancer
Official Title  ICMJE A Pilot Dose Finding Study of MUC1 Vaccine in Conjunction With Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) or HiltonolTM in Patients With Recurrent and/or Advanced Prostate Cancer
Brief Summary The purpose of this study is to determine the effectiveness of a drug called Poly-ICLC, also known as HiltonolTM, in boosting the body's immune system's response to an experimental vaccine therapy (called the MUC-1 vaccine).
Detailed Description This is a one-arm clinical trial, to evaluate 2 doses of poly-ICLC for reversing systemic immuno-suppression: 25 μg/kg and 50 μg/kg. These doses will be administered I.M. three times a week for 2 weeks. Following 2 weeks of treatment with poly-ICLC alone, patients will be immunized subcutaneously with the 100-mer MUC-1 peptide + GM-CSF. Subjects will be boosted twice at two week intervals, and subsequently 3 months later, if they experience clinical benefit or if they have clinically stable disease. Poly-ICLC will be administered continually 3 times a week I.M. for the first 2 weeks and 2 times a week I.M. thereafter. Subjects will continue on study until they have evidence of progressive disease. The primary objective of this study is to evaluate the efficacy of Poly-ICLC in boosting the immunologic response of a MUC1 vaccine. Secondary objectives are to evaluate a) changes in markers of systemic immunosuppression; b) changes in dendritic cell number and function; and c) clinical response. Up to 30 subjects will be enrolled in this single-site study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: MUC_1
Pretreatment with Poly-ICLC alone week 1 &2 (50 ug/kg 3 days/week) Weeks 3-7 Poly-ICLC, 2 days/week; MUC-1 vaccine (100ug) admixed with GM-CSF (100ug), administered subcutaneously at weeks 3, 5 and 7 Tetanus toxoid, administered via intramuscular injection, 1x at week 3 GM-CSF 100ug, administered subcutaneously on days 2-4
Study Arms  ICMJE Experimental: One
MUC1 vaccine in conjunction with GM-CSF and Poly-ICLC (Hiltonol)in Arm ONE
Intervention: Drug: MUC_1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2016)
14
Original Enrollment  ICMJE
 (submitted: September 7, 2006)
30
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older and must have histologically confirmed adenocarcinoma of the prostate with systemic disease are potentially eligible. Patients with an early relapse must have undergone and failed definitive surgery and/or radiation. Patients can either be hormone naive, may be on concurrent hormone therapy with LHRH analogues, or may be hormone refractory (see section 3.1.4 of the full protocol)
  • Must have evidence of systemic immunosuppression as evidenced by the presence of one or more of the following: 1) Low or absent T cell zeta chain expression in peripheral blood (PB), 2) Low level cytokine production ( i.e., IFN-gamma , IL-4 ) by T cells in PB, 3) Upregulation of granulocyte activation markers (CD 15) in PB
  • Availability of at least 2 PSA measurements over 2 to 6 weeks, clearly documenting a rising PSA. The minimum rise in PSA must be at least 50% from baseline PSA. The last of these PSA values must be > 2 .
  • Patients may be hormone-refractory (rising PSA, despite castrate testosterone levels, i.e., < 50 ng/ml); may have metastatic disease; and maybe on bisphosphonates. If patients are on anti-androgens (Flutamide/Casodex), they must have been off of these agents for at least 28 days prior to enrollment for flutamide, and at least 42 days prior to enrollment for bicalutamide (Casodex)), without a drop in PSA. If hormone refractory, patients will continue LHRH analogues.
  • Signed written informed consent given by the patient before or at enrollment in the study and following receipt of verbal and written information about the study.
  • No concomitant therapy with steroids
  • No other investigational therapy within 4 weeks of enrolling on this protocol
  • No chemotherapy or radiation therapy within 6 weeks of enrolling on this protocol.
  • ECOG performance status 0 or 1
  • Patients must have adequate organ and marrow function
  • Men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.

Exclusion Criteria:

  • Patients who have had chemotherapy or radiation therapy within 6 weeks of study entry.
  • No concurrent use of other investigational agents.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Presence of an active acute or chronic infection, including urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot) or viral hepatitis (as determined by HBsAg and Hepatitis C serology). HIV patients are excluded based on immunosuppression which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
  • Patients with either previously irradiated or new CNS (central nervous system) metastases at entry are excluded. Pre-enrollment head CT is not required if not indicated by clinical signs or symptoms.
  • Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis.
  • Subjects with active prior malignancy within the past 5 years (with exception of non-melanoma skin cancers and carcinoma in situ of the bladder).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00374049
Other Study ID Numbers  ICMJE 05-086
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Olivera Finn, University of Pittsburgh
Study Sponsor  ICMJE Olivera Finn
Collaborators  ICMJE Oncovir, Inc.
Investigators  ICMJE
Principal Investigator: Leonard J Appleman, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP