Biological Therapy in Treating Patients With 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. Identifier: NCT00039299
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 4, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's T cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of T-cell therapy in treating patients who have prostate cancer that has not responded to hormone therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: therapeutic autologous lymphocytes Phase 1

Detailed Description:


  • Determine the safety of activated autologous T cells (Xcellerate) therapy in patients with hormone-refractory prostate cancer.
  • Determine the change in prostate-specific antigen (PSA) levels in patients treated with this therapy.
  • Determine the effects on bone in patients treated with this therapy.

OUTLINE: This is a multicenter study.

Patients undergo leukapheresis to collect peripheral blood mononuclear cells (PBMC). PBMC are activated and expanded ex vivo by costimulation with antihuman CD3 and antihuman CD28 monoclonal antibodies covalently attached to superparamagnetic microbeads (Xcellerate). Xcellerate-activated T cells are reinfused on day 0.

Patients are followed weekly for 4 weeks and then monthly for 3 months.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer
Study Start Date : March 2002
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Evidence of androgen-independent disease

      • Patient must have received prior primary hormonal therapy (e.g., orchiectomy or gonadotropin-releasing hormone analog with or without antiandrogen)
      • Demonstrated disease progression by any 1 of the following:

        • Elevated PSA level (at least 5 ng/mL) that has serially risen from baseline on 2 occasions at least 1 week apart
        • At least 1 new osseous lesion on bone scan
        • More than 25% increase in the sum of the products of the perpendicular diameters of all bidimensionally measurable sites of disease
  • No CNS metastases



  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 3 months


  • Not specified


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGPT no greater than 1.5 times ULN
  • Hepatitis B surface antigen negative
  • No active or chronic hepatitis B or C
  • No other hepatic dysfunction that would preclude study


  • Creatinine less than 2.0 mg/dL
  • Calcium less than 11 mg/dL
  • No renal dysfunction that would preclude study
  • No symptomatic hypercalcemia


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


  • No pulmonary disease requiring inhaled steroids or bronchodilators


  • No history of HIV 1 or 2 or human T-cell lymphotrophic virus (HTLV) 1 or 2
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
  • No history of autoimmune disease (e.g., rheumatoid arthritis or multiple sclerosis)
  • No other major organ system dysfunction
  • No gastrointestinal, neurologic, or psychiatric dysfunction that would preclude study
  • Human anti-mouse antibody negative


Biologic therapy:

  • No concurrent growth factors, interleukin, interferons, or cytokines


  • No prior chemotherapy or other systemic chemotherapy agent for prostate or any other cancer

Endocrine therapy:

  • Prior aminoglutethimide allowed
  • At least 4 weeks since prior flutamide
  • At least 6 weeks since prior bicalutamide or nilutamide
  • Concurrent luteinizing hormone-releasing hormone agonists should be continued
  • No concurrent corticosteroids or dexamethasone
  • No concurrent anti-androgens (e.g., flutamide, bicalutamide, or nilutamide)


  • At least 4 weeks since prior local radiotherapy
  • No prior radiopharmaceutical therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
  • No concurrent radiotherapy


  • Not specified


  • Prior ketoconazole or PC-SPES allowed
  • At least 1 week since prior antibiotic, antifungal, or antiviral agents
  • At least 4 weeks since other prior systemic therapy for prostate cancer (except bisphosphonates or hormonal therapy)
  • At least 6 weeks since prior investigational drugs or devices
  • No other concurrent therapy for this disease
  • No concurrent participation in another clinical trial
  • No concurrent bisphosphonates unless initiated prior to study
  • No concurrent immunosuppressive drugs
  • No other concurrent experimental therapies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00039299

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1738
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Allan Pantuck, MD Jonsson Comprehensive Cancer Center Identifier: NCT00039299     History of Changes
Other Study ID Numbers: XCYTE-SPR-080011
CDR0000069370 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: June 2003

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases