Phase I/II Study of Vaccination With Antigen Loaded Dendritic Cells (DCs) in Hormone-Refractory Prostate Cancer

NCT01897207 | Completed Phase 1

• 1 other identifier: SG226_02
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main aim of this trial is to assess the response rate, the feasibility and toxicity of the treatment with antigen loaded Dendritic Cell Vaccination in Prostate Cancer patients. Furthermore we want to investigate biological responses by measuring markers of in-vivo and ex-vivo immunomodulation.

Conditions

Cancer of the Prostate

Keywords

prostate cancer; dendritic cells; vaccination

Outcome Measures

Primary Outcomes (3)

• tolerability and toxicity and feasibility of this regimen

  directly after vaccination (within 24 h)

• response rate or PSA response in non measurable disease

  The given time frame reflects the minimum of PSA values. From Patients receiving more than 6 DC vaccination every 4 weeks PSA was determined until the end of DC vaccination (longest was one and a half year).

  Change from baseline in serum PSA at 6, 10 and 12 weeks

• ex-vivo immunomodulation

  Peripheral blood mononuclear cells (PBMC) isolation and in-vitro restimulation. Measurement of antigen specific immune responses.

  before vaccination, after 6, 10, 12, and up to 85 weeks

Secondary Outcomes (2)

• pain relief

  Change from baseline in pain relief at 2, 4, 6, 8, 10 and 12 weeks

• Overall survival

  From first date of treatment until dead

Study Arms (1)

Dendritic cell application

EXPERIMENTAL

Biological: Dendritic cell application

Interventions

Dendritic cell application BIOLOGICAL

S.C. injection of peptide pulsed autologous dendritic cells

Dendritic cell application

Eligibility Criteria

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

You may qualify if:

• histologically or cytologically proven prostatic carcinoma
• proven hormonal resistance: tumor progression after orchiectomy or during treatment with hormonal agents. Patients treated with antiandrogens, such as flutamide (Flucinom) or bicalutamide (Casodex), should have been discontinued the drug 6 weeks prior to the trial entry followed by no tumor response within this 6 weeks
• not amenable to curative therapy
• patients with measurable and non-measurable disease may be included. Bone lesions only are considered to be non-measurable
• two consecutive increases of prostate-specific antigen (PSA) should be documented over a previous reference value (N°1). The first increase in PSA (N°2) should occur a minimum of one week from the reference value and be confirmed (N°3). If this value is less than the previous value, the patient is still eligible if the next PSA(N°4) is found to be higher than the second PSA. Serum levels of prostate-specific antigen must be at least 10 microg/l
• Previous radiotherapy is allowed if it has been stopped 4 weeks or more before the trial treatment and did not involve lesions used to evaluate activity of the trial drugs
• one previous chemotherapy (including Estracyt) is allowed, but the chemotherapy should have been stopped at least 6 weeks before study entry
• age \>18 years
• performance status 0,1,2 (ECOG, Appendix I)
• no concurrent therapy with steroids
• no uncontrolled infections
• live expectancy more than 3 months
• Human leukocyte antigen (HLA)-Type has to be HLA\*A201
• neutrophile count \>1500/microl and thrombocytes \>100 000/microl
• creatinine \<1.5 of upper normal level

You may not qualify if:

• serious concomitant disease (cardiac, pulmonary and others)
• brain metastasis
• previous splenectomy or radiotherapy to the spleen
• concurrent therapy with immunosuppressive drugs
• chronic immunosuppression (includes transplantation or HIV-infection) HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) (test required) or any other severe uncontrolled infection other neoplastic diseases except: curatively treated basal cell or squamous cell carcinoma of the skin or relapse free for more than 5 years after curative treatment of a neoplasm
• treatment with other investigational drugs during the last month
• severe autoimmune disease
• chemotherapy, radiotherapy or immunotherapy less than 6 weeks before study entry
• Ejection fraction (measured by echocardiography) \< 40%

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

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

• Thomas Cerny, Prof. Dr.

  Department of Medical Oncology, Cantonal Hospital St. Gallen, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 11, 2013
• Study Start: November 1, 2002
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2011
• Last Updated: August 17, 2015

Record last verified: 2015-08