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TerminatedNCT00010127Updated Mar 21, 2013

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer

A Phase 1 interventional study of therapeutic autologous dendritic cells in Prostate Cancer, sponsored by Duke University. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-21.

Sponsored by Duke University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
3
Ages
18 Years and older
Sex
Male
01

Study summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill prostate tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer.

Read the detailed description

OBJECTIVES:

  • Determine the safety and feasibility of autologous dendritic cells transfected with autologous total tumor RNA in patients with metastatic prostate cancer.
  • Determine the presence, frequency, and activation status of tumor specific and prostate specific antigen (PSA) specific cellular immune responses in patients treated with this regimen.
  • Determine delayed-type hypersensitivity reactions to PSA protein and other recall antigens in patients before and after being treated with this regimen.
  • Determine clinical responses based on clinical and biochemical (PSA) response criteria in patients treated with this regimen.
  • Determine a platform for immunological treatment using dendritic-cell based tumor vaccines in these patients.

OUTLINE: This is a dose escalation study.

Tumor tissue and peripheral blood stem cells are collected from patients and cultured in vitro with sargramostim (GM-CSF) and interleukin-4 for 7 days to produce dendritic cells (DC). Patients receive autologous DC transfected with autologous prostate carcinoma RNA intradermally once weekly on weeks 0-3 for a total of 4 doses.

Cohorts of 3-6 patients receive escalating doses of DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at weeks 6, 8, 10, and 12; every 3 months for 9 months; and then annually for 2 years.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 20 months.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • adenocarcinoma of the prostate
  • stage IV prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 3 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic adenocarcinoma of the prostate

    • Stage D1-3
    • Regional lymph node, bone, visceral, or soft tissue metastases
    • No transitional cell or small cell carcinoma
  • Testosterone less than 50 mg/L if prior treatment with luteinizing hormone releasing hormone (LHRH) analogues or estrogens
  • Evidence of androgen refractory disease after surgical castration and discontinuation of LHRH analogue therapy
  • No previously irradiated or new CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 6 months

Hematopoietic:

  • WBC at least 3,000/mm\^3
  • Hemoglobin at least 9 g/dL
  • Platelet count at least 100,000/mm\^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • PT at least 11.3 seconds but no greater than 13.3 seconds
  • PTT at least 20.1 seconds but no greater than 32.9 seconds
  • No hepatic disease
  • No viral hepatitis

Renal:

  • Creatinine less than 2.5 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Pulmonary:

  • No asthma
  • No chronic obstructive pulmonary disease
  • No severe lung disease

Other:

  • No other medical illness or psychological impediment that would preclude study
  • No other concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer
  • No active acute or chronic infection including symptomatic urinary tract infection
  • No autoimmune disease (e.g., inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis)
  • HIV negative
  • Adequate peripheral vein access

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior biologic therapy allowed
  • No other concurrent immunotherapy

Chemotherapy:

  • Prior chemotherapy allowed
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior non-steroidal hormonal therapy if increase in PSA while receiving non-steroidal hormonal therapy
  • At least 6 weeks since prior steroids
  • Concurrent LHRH analogues for gonadal androgen suppression allowed
  • No concurrent steroid therapy
  • No concurrent corticosteroids

Radiotherapy:

  • See Disease Characteristics
  • Prior palliative radiotherapy for bone metastases allowed
  • Prior prostatic radiotherapy allowed
  • At least 4 weeks since prior radiotherapy
  • At least 12 weeks since prior strontium chloride Sr 89
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • Recovered from prior therapy
  • No concurrent immunosuppressive agents (e.g., azathioprine or cyclosporine)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
3 participants (actual)

Interventions

  • Biologicaltherapeutic autologous dendritic cells
06

Study locations

1 site
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00010127
Lead sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 30, 2003
Start date
Nov 2000
Completion
Mar 2003
Last update
Mar 21, 2013

Study contacts

Johannes Vieweg, MD
study chair · Duke Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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