Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer

NCT00814892 | Terminated Phase 2 Results DMC

• 2 other identifiers: MC055406-004659
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is more effective in treating patients with prostate cancer. PURPOSE: This phase II trial is studying how well the combination of a proven effective allogenic whole prostate carcinoma cell (APCC) vaccine co-administered with ex vivo generated dendritic cells (DCs)(DC-APCC) extend the time to prostate cancer progression.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Are Progression Free at One Year

  Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level \<200.0 ng/mL.

  One year

Secondary Outcomes (6)

• Number of Participants With Severe Adverse Events

  Every cycle during treatment (up to 14 cycles)

• Time to Prostate-cancer Specific Mortality

  Registration to Prostate-cancer specific mortality (Up to 3 years)

• Time to Prostate-specific Antigen (PSA) Progression

  Registration to PSA progression (Up to 3 years)

• Duration of PSA-based Response

  Up to 3 years

• Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire

  Baseline and cycle 1

Study Arms (1)

DC-APCC

EXPERIMENTAL

Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.

Biological: allogeneic tumor cell vaccine; Biological: therapeutic autologous dendritic cells

Interventions

allogeneic tumor cell vaccine BIOLOGICAL

Given intradermally

DC-APCC

therapeutic autologous dendritic cells BIOLOGICAL

Given intradermally

DC-APCC

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Biochemically progressive disease defined by two serial PSA measurements obtained ≥ 1 week apart during ongoing optimal androgen-deprivation therapy (e.g., orchiectomy, luteinizing hormone-releasing hormone \[LHRH\] agonist, or another equivalent hormonal agent) * Concurrent LHRH agonist or high-dose bicalutamide required (unless patient has undergone prior orchiectomy) * Has undergone prior standard primary therapy for prostate cancer (e.g., radical prostatectomy, radiotherapy, or an equivalent initial treatment directed towards localized prostate cancer) * PSA 2.0-100.0 ng/mL * Serum testosterone \< 50 ng/dL (unless undergoing antiandrogen monotherapy) * No concurrent evidence of radiological or new clinically palpable metastatic cancer PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 12 weeks * WBC ≥ 3,500/µL * Platelet count ≥ 100,000/µL * Hemoglobin ≥ 10.0 g/dL * Creatinine ≤ 2.0 mg/dL * Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN) * AST ≤ 2.5 times ULN * Fertile patients must use effective contraception * Willing to provide blood samples for research purposes * Able to complete questionnaire(s) alone or with assistance * Able to undergo leukapheresis * No known immunodeficiency * No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only * No concurrent serious illness * No known history of positive PPD skin test PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * More than 1 month since prior and no concurrent corticosteroids or other immunosuppressive agents * Inhaled corticosteroids allowed * More than 1 month since prior and no concurrent estrogens and/or ketoconazole * More than 3 months since prior and no other concurrent investigational medicinal products * More than 4 weeks since prior and no concurrent secondary hormonal maneuver with or without a peripheral antiandrogen (e.g., bicalutamide), PC-SPES, or any other herbal medicines used to treat prostate cancer * No prior prostate cancer vaccine * No other therapy for prostate cancer (e.g., chemotherapy, immunotherapy, radiotherapy, or new hormonal therapy) during and for 4 months after completion of study therapy * No other concurrent standard therapy that is potentially curative or proven capable of extending life expectancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, 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

Results Point of Contact

• Title: Dr. Manish Kohli
• Organization: Mayo Clinic

kohli.manish@mayo.edu

507-284-2511

Study Officials

• Manish Kohli, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 25, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: November 5, 2013
• Results First Posted: August 29, 2013

Record last verified: 2013-10

Locations

US (1)