Prostate CancerPhase 2NCT00400517
GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
A Phase 2 study testing sargramostim, thalidomide and conventional surgery in people with Prostate Cancer, run by The Cleveland Clinic at 1 site in United States.
Trial summary
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Read more about this study
- Who is it for?
- Ages Up to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- sargramostim, thalidomide and conventional surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 120 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate meeting any of the following criteria for high-risk disease:
- Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific antigen [PSA])
- Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA)
- Serum PSA ≥ 10 ng/dL (any grade or stage)
- Any stage, PSA, or Gleason score with ≥ 35% chance of biochemical failure at 5 years based on Kattan's nomogram
- No clinical evidence of CNS metastases
- No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan, x-ray) within 8 weeks of study entry
- Appropriate medical candidate for radical prostatectomy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Creatinine ≤ 2.0 mg/dL
- Granulocyte count ≥ 1,800/mm³
- Platelet count ≥ 100,000/mm³
- AST < 3 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
- Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment
- No active unresolved infection
- No pre-existing peripheral neuropathy > grade 1
- No known HIV positivity
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or controlled Ta transitional cell carcinoma of the bladder
- No known contraindication to sargramostim (GM-CSF) or thalidomide
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the prostate or pelvis
- No prior chemotherapy or hormonal therapy for prostate cancer
- No parenteral antibiotics within the past 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.
Read the detailed description
OBJECTIVES:
- Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic response (histologic P0, margin positivity, capsular penetration), prostate-specific antigen (PSA) response, and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy.
- Determine the safety and feasibility of GM-CSF and thalidomide.
OUTLINE: This is an open-label study.
Patients receive sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4. Treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity.
Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- sargramostim, thalidomide, conventional surgery, neoadjuvant therapy
- Keywords
- stage III prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate, stage I prostate cancer, stage IV 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.
sargramostimBiological
Also called GM-CSF
administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day
thalidomideDrug
Also called THALOMID
doses up to 400 mg/day
conventional surgeryProcedure or surgery
SOC care surgery
neoadjuvant therapyProcedure or surgery
post radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF Injections and Oral Thalidomide | Experimental | taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. Receives: Biological: sargramostim; Drug: thalidomide; Procedure: conventional surgery; Procedure: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients P0 at Surgery
Pathologic Complete Response is defined as complete eradication of tumor.
Measured: 8 weeks
Proportion of Patients With Negative Surgical Margins
Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy.
Measured: 8 Weeks
Prostate-specific Antigen Response
Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry.
Measured: 8 weeks
Time to Clinical Progression
Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startMar 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jorge Garcia, MD, FACP, Principal investigator, The Cleveland ClinicEric Klein, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400517
- Sponsor's protocol ID
- CASE-CCF-4643
- Other IDs
- P30CA043703, CASE-CCF-4643, CELGENE-CASE-CCF-4643, BRLX-CASE-CCF-4643
- Status last verified
- Jul 2018
- First submitted
- 16 Nov 2006
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy
- ClinicalTrials.gov ID
- NCT00400517
- Acronym / sponsor ID
- CASE-CCF-4643
- Conditions
- Prostate Cancer
- Keywords
- stage III prostate cancer, stage II prostate cancer, adenocarcinoma of the prostate, stage I prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Posted 28 Aug 2018
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, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.
Detailed description
OBJECTIVES:
- Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic response (histologic P0, margin positivity, capsular penetration), prostate-specific antigen (PSA) response, and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy.
- Determine the safety and feasibility of GM-CSF and thalidomide.
OUTLINE: This is an open-label study.
Patients receive sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4. Treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity.
Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9.
PROJECTED ACCRUAL: A total of 29 patients will be 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 |
|---|---|---|
| GM-CSF Injections and Oral Thalidomide | Experimental | Biological: sargramostim, Drug: thalidomide, Procedure: conventional surgery, Procedure: neoadjuvant therapytaught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease. |
Who may qualify
- Ages
- Up to 120 years
- 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 |
|---|---|---|
| sargramostimAlso: GM-CSFadministered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day | Biological | GM-CSF Injections and Oral Thalidomide |
| thalidomideAlso: THALOMIDdoses up to 400 mg/day | Drug | GM-CSF Injections and Oral Thalidomide |
| conventional surgerySOC care surgery | Procedure or surgery | GM-CSF Injections and Oral Thalidomide |
| neoadjuvant therapypost radical prostatectomy | Procedure or surgery | GM-CSF Injections and Oral Thalidomide |
Primary outcome
Proportion of Patients P0 at Surgery
Time frame: 8 weeks
Pathologic Complete Response is defined as complete eradication of tumor.
Proportion of Patients With Negative Surgical Margins
Time frame: 8 Weeks
Presence or Absence of prostate cancer tissue at the sites of surgical resection. This is done by reviewing the entire specimen resected at the time or Radical Prostatectomy.
Prostate-specific Antigen Response
Time frame: 8 weeks
Number of subjects that achieved a PSA decline while on therapy. Any PSA decline while on treatment, compared with baseline PSA prior to study entry.
Time to Clinical Progression
Time frame: 32 months
Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jorge Garcia, MD, FACP principal investigator
The Cleveland Clinic
Eric Klein, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sargramostim, thalidomide and conventional surgery in people with Prostate Cancer, run by The Cleveland Clinic 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 28 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients P0 at Surgery (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 28 Aug 2018.