Prostate CancerPhase 1NCT00039299
Biological Therapy in Treating Patients With Prostate Cancer
A Phase 1 study testing therapeutic autologous lymphocytes in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- therapeutic autologous lymphocytes
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Jun 2003
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1738
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- therapeutic autologous lymphocytes
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic autologous lymphocytesBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2002
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Allan Pantuck, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039299
- Sponsor's protocol ID
- XCYTE-SPR-080011
- Other IDs
- UCLA-0111008, CDR0000069370, XCYTE-XT002, NCI-G02-2075
- Status last verified
- Jun 2003
- First submitted
- 6 Jun 2002
- Last updated
- 4 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety Study Of Xcellerate In Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00039299
- Acronym / sponsor ID
- XCYTE-SPR-080011
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2002
- Study completion
- Jun 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic autologous lymphocytes | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Pantuck, MD study chair
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing therapeutic autologous lymphocytes in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.