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Prostate CancerPhase 2NCT00015977

Vaccine Therapy Plus Interleukin-12 in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

A Phase 2 study testing PSA prostate cancer vaccine and recombinant interleukin-12 in people with Prostate Cancer, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Vaccines made from a patient's white blood cells may make the body build an immune response to kill cancer cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
PSA prostate cancer vaccine and recombinant interleukin-12
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
Nov 2001to Jan 2005
Phase
Phase 2
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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic adenocarcinoma of the prostate
  • HLA-A2 positive
  • Progressive measurable systemic disease
  • PSA at least 5 ng/mL with 2 consecutive rising PSA levels at least 1 week apart and no measurable disease OR
  • Objective evidence of disease progression by a 20% increase in the sum of longest diameter of all target lesions or evidence of new lesions by CT or bone scan regardless of PSA status
  • Lesions must be at least 1 cm to be considered measurable
  • Progressive systemic disease after discontinuation of anti-androgen therapy
  • Previously treated with orchiectomy (testosterone less than 50 ng/mL) OR luteinizing hormone-releasing hormone (LHRH) analogue therapy with or without anti-androgens
  • If on LHRH analogue therapy, must continue therapy during study
  • Brain metastases allowed if previously treated, clinically stable, and weaned from prior corticosteroids

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Hemoglobin greater than 9 g/dL
  • Platelet count greater than 100,000/mm^3
  • No active gastrointestinal bleeding

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGPT normal
  • Hepatitis B surface antigen negative

Renal:

  • Creatinine less than 1.5 times ULN
  • Calcium less than 11 mg/dL

Cardiovascular:

  • No significant cardiovascular disease
  • No cardiac arrhythmia requiring therapy

Other:

  • Fertile patients must use effective barrier contraception
  • No intrinsic immunosuppression
  • HIV negative
  • No serious concurrent infection
  • No psychiatric illness that would preclude study compliance
  • No clinically significant autoimmune disease
  • No uncontrolled peptic ulcer disease
  • No history of inflammatory bowel disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior flutamide
  • At least 6 weeks since prior bicalutamide or nilutamide
  • No concurrent systemic corticosteroids except physiologic replacement doses

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent immunosuppressive drugs (e.g., cyclosporine)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

Other trials in United States

About this study

Official title: Phase II Study of Immunization With PSMA Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Prostate Cancer

RATIONALE: Vaccines made from a patient's white blood cells may make the body build an immune response to kill cancer cells. Interleukin-12 may kill cancer cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-12 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy combined with interleukin-12 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Read the detailed description

OBJECTIVES:

  • Determine whether immunization with prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells and interleukin-12 can promote specific T-cell priming in patients with metastatic hormone-refractory prostate cancer.
  • Determine the clinical response in patients treated with this regimen.

OUTLINE: Patients receive prostate-specific membrane antigen-pulsed autologous peripheral blood mononuclear cells subcutaneously (SC) on day 1 and interleukin-12 SC on days 1, 3, and 5. Treatment repeats every 21 days for 3-9 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 37 weeks.

Conditions
Prostate Cancer
Being tested
PSA prostate cancer vaccine, recombinant interleukin-12
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, 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.

  • PSA prostate cancer vaccineBiological

  • recombinant interleukin-12Biological

    Also called IL-12, rhIL-12

Study groups in NCT00015977
Study groupRoleWhat they receive
PSMA peptide vaccineExperimentalImmunization with PSMA peptide vaccine followed by injection of Interleukin-12 (IL-12) on Day 1 of a 21-day cycle. Additional injections of IL-12 given on Days 3 and 5 of each cycle.
Receives: Biological: PSA prostate cancer vaccine; Biological: recombinant interleukin-12

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease response

    Measured: 63 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 2001
  3. Primary completionMar 2003
  4. Study completionJan 2005

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00015977
Sponsor's protocol ID
9845
Other IDs
UCCRC-9845, NCI-1192
Status last verified
Mar 2014
First submitted
6 May 2001
Last updated
7 Mar 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PSA prostate cancer vaccine and recombinant interleukin-12 in people with Prostate Cancer, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Disease response (time frame: 63 days). It is what the study was designed to measure, not a finding.

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 7 Mar 2014.

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