Prostate CancerPhase 1/2NCT00005072
Leuvectin in Treating Patients With Locally Recurrent Prostate Cancer
A Phase 1/2 study testing Leuvectin in people with Prostate Cancer, run by Vical at 2 sites in United States.
Trial summary
RATIONALE: Inserting the gene for interleukin-2 into a person's prostate cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of Leuvectin in treating patients who have locally recurrent prostate cancer after receiving treatment with… 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?
- Leuvectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2000to Apr 2003
- Phase
- Phase 1/2
- 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 proven locally recurrent organ-confined prostate cancer after external beam radiotherapy, radiation seed implants, or cryosurgery. Gleason score of at least 6. Prostate specific antigen values (PSA) of at least 1.0 ng/mL with 2 consecutive rises in PSA at least 2 weeks apart, of which the second increase is greater than the first, after achieving a nadir. Must have at least 3 recorded PSA values over a minimum of the last 3 months to determine the slope. Patients must have declined additional conventional treatment or be ineligible for conventional treatment of their prostate cancer. No metastasis by bone scan. No significant central nervous system (CNS) disease.
PATIENT CHARACTERISTICS: Age: 18 and over. Performance status: Karnofsky 80-100% OR Eastern Cooperative Oncology Group (ECOG) 0 or 1. Life expectancy: Not specified. Hematopoietic: White blood cell count (WBC) greater than 3,000/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 9.0 g/dL. Hepatic: Bilirubin normal. Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) less than 3 times upper limit of normal. Albumin greater than 3 g/dL. Prothrombin time (PT) and partial thromboplastin time (PTT) normal. Hepatitis B surface antigen negative. Renal: Creatinine normal. Cardiovascular: No uncontrolled hypertension. No significant cardiovascular disease, e.g.: History of ventricular dysfunction; Congestive heart failure; Symptoms of coronary artery disease; History of any ventricular arrhythmia; Prior myocardial infarction. Other: HIV negative. Fertile patients must use effective double-barrier contraception during and for 3 months after study participation. No active autoimmune disease. No active infection requiring IV antibiotics. No uncontrolled diabetes mellitus. No significant psychiatric disorder that would preclude study. No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer.
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior Leuvectin. Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or hydroxyurea). Endocrine therapy: No prior hormonal therapy for prostate cancer. Radiotherapy: See Disease Characteristics. At least 3 weeks since prior radiotherapy. Surgery: At least 1 month since prior intrathoracic or intra-abdominal surgery. At least 2 weeks since other prior major surgery. Other: At least 10 days since prior anticoagulants or non-steroidal anti-inflammatory agents. No neoadjuvant or other concurrent anticancer drug therapy. No concurrent immunosuppressive drugs. No other concurrent experimental therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Phase I/II Study Evaluating the Safety and Efficacy of Leuvectin Immunotherapy for the Treatment of Locally Recurrent Prostate Cancer Following Radiation Therapy (Summary Last Updated: 02/2001)
RATIONALE: Inserting the gene for interleukin-2 into a person's prostate cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of Leuvectin in treating patients who have locally recurrent prostate cancer after receiving treatment with radiation therapy.
Read the detailed description
OBJECTIVES: I. Determine the toxicity and tolerability of Leuvectin in patients with locally recurrent organ-confined prostate cancer after radiotherapy. II. Determine the efficacy of this regimen in preventing or delaying manifestations of disease progression as demonstrated by biochemical failure or clinical recurrence in this patient population.
OUTLINE: This is an open-label, multicenter study. Patients receive Leuvectin intraprostatically over 10-30 seconds under transrectal ultrasound guidance on days 0 and 14. Patients are re-evaluated at week 10. Treatment repeats every 10-11 weeks or 1-6 days after completion of each week 10 re-evaluation for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years in the absence of disease progression.
ACTUAL ACCRUAL: A total of 25 patients were accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- Leuvectin
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA 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.
LeuvectinBiological
Also called Interleukin-2 (IL-2) plasmid DNA/lipid complex
1000 ug of Leuvectin injected intratumorally
| Study group | Role | What they receive |
|---|---|---|
| Leuvectin | Experimental | Leuvectin Receives: Biological: Leuvectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Leuvectin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2003 (estimated)
- Study startNov 2000
- Primary completionApr 2003
- Study completionApr 2003
Why it stopped: Development in prostate cancer indication halted
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arie Belldegrun, MD, FACS, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005072
- Sponsor's protocol ID
- VCL-1102-203
- Other IDs
- UCLA-9906108, CDR0000067677, NCI-G00-1721
- Status last verified
- Jul 2014
- First submitted
- 6 Apr 2000
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study Evaluating the Safety and Efficacy of Leuvectin Immunotherapy for the Treatment of Locally Recurrent Prostate Cancer Following Radiation Therapy (Summary Last Updated: 02/2001)
- ClinicalTrials.gov ID
- NCT00005072
- Acronym / sponsor ID
- VCL-1102-203
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, recurrent prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development in prostate cancer indication halted
- Enrolment
- 25 participants (actual)
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Collaborators
- Jonsson Comprehensive Cancer Center, National Cancer Institute (NCI)
- Study start
- Nov 2000
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 4 Nov 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: Inserting the gene for interleukin-2 into a person's prostate cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of Leuvectin in treating patients who have locally recurrent prostate cancer after receiving treatment with radiation therapy.
Detailed description
OBJECTIVES: I. Determine the toxicity and tolerability of Leuvectin in patients with locally recurrent organ-confined prostate cancer after radiotherapy. II. Determine the efficacy of this regimen in preventing or delaying manifestations of disease progression as demonstrated by biochemical failure or clinical recurrence in this patient population.
OUTLINE: This is an open-label, multicenter study. Patients receive Leuvectin intraprostatically over 10-30 seconds under transrectal ultrasound guidance on days 0 and 14. Patients are re-evaluated at week 10. Treatment repeats every 10-11 weeks or 1-6 days after completion of each week 10 re-evaluation for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years in the absence of disease progression.
ACTUAL ACCRUAL: A total of 25 patients were accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leuvectin | Experimental | Biological: LeuvectinLeuvectin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| LeuvectinAlso: Interleukin-2 (IL-2) plasmid DNA/lipid complex1000 ug of Leuvectin injected intratumorally | Biological | Leuvectin |
Primary outcome
Safety of Leuvectin
Results and safety
The study was stopped early (reason given: Development in prostate cancer indication halted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
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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.
Arie Belldegrun, MD, FACS study chair
Jonsson Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Leuvectin in people with Prostate Cancer, run by Vical at 2 sites 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: stopped early, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
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 was stopped early (reason given: Development in prostate cancer indication halted). Results are not available in the source record.
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?
Safety of Leuvectin. 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 29 Jul 2014.