Biological Therapy in Treating Patients With Prostate Cancer

April 2, 2013 updated by: Jonsson Comprehensive Cancer Center

A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1738
        • Jonsson Comprehensive Cancer Center, UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Not specified

Hepatic:

  • 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

Renal:

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

Cardiovascular:

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

Pulmonary:

  • No pulmonary disease requiring inhaled steroids or bronchodilators

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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)

Radiotherapy:

  • 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

Surgery:

  • Not specified

Other:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Allan Pantuck, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion (Actual)

June 1, 2003

Study Registration Dates

First Submitted

June 6, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

June 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XCYTE-SPR-080011
  • UCLA-0111008
  • CDR0000069370 (Registry Identifier: PDQ (Physician Data Query))
  • XCYTE-XT002
  • NCI-G02-2075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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