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

NCT00374049 | Completed Phase 1 DMC

• 1 other identifier: 05-086
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Prostate; vaccine; immunosuppression; dendritic cells

Outcome Measures

Primary Outcomes (1)

• Proportion of patients showing an immunologic response at week 8

  8weeks

Secondary Outcomes (4)

• Measures of systemic immunosuppression

  8weeks

• Dendritic cell (DC) status

  7 weeks

• T cell subset analyses

  8weeks

• Clinical Response

  weekly

Study Arms (1)

One

EXPERIMENTAL

MUC1 vaccine in conjunction with GM-CSF and Poly-ICLC (Hiltonol)in Arm ONE

Drug: MUC_1

Interventions

MUC_1 DRUG

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

One

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Olivera Finn: lead
• Oncovir, Inc.: collaborator

Study Sites (1)

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Leonard J Appleman, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Distinguished Professor and Chair, Department of Immunology

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: December 1, 2015
• Last Updated: July 12, 2016

Record last verified: 2015-12

Locations

US (1)