A Phase 2 interventional study of sargramostim and thalidomide in Prostate Cancer, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to male participants aged Up to 120 Years. Per ClinicalTrials.gov, last updated 2018-08-28.
Sponsored by The Cleveland Clinic · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 28 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate meeting any of the following criteria for high-risk disease:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
Biological: sargramostim · Drug: thalidomide · Procedure: conventional surgery · Procedure: neoadjuvant therapy
administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day
Also known as: GM-CSF
doses up to 400 mg/day
Also known as: THALOMID
SOC care surgery
post radical prostatectomy
Proportion of Patients P0 at Surgery
Pathologic Complete Response is defined as complete eradication of tumor.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 32 months
| Milestone | GM-CSF Injections and Oral Thalidomide |
|---|---|
| Started | 28 |
| Completed | 26 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Physician decision | 1 |
Pathologic Complete Response is defined as complete eradication of tumor.
| Participants | GM-CSF Injections and Oral Thalidomide |
|---|---|
| Proportion of Patients P0 at Surgery | 0 |
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.
| Participants | GM-CSF Injections and Oral Thalidomide |
|---|---|
| Proportion of Patients With Negative Surgical Margins | 0 |
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.
| Participants | GM-CSF Injections and Oral Thalidomide |
|---|---|
| Prostate-specific Antigen Response | 22 |
Time to progression. WIth a median follow up of 32 months (12-51 months), 5 of 26 patients developed biochemical failure.
| Participants | GM-CSF Injections and Oral Thalidomide |
|---|---|
| Time to Clinical Progression | 5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GM-CSF Injections and Oral Thalidomide | — | 3/27 (11.1%) | 27/27 (100%) |
| Event | GM-CSF Injections and Oral Thalidomide |
|---|---|
| Injection Site ReactionSkin and subcutaneous tissue disorders | 1/27 |
| UrticariaSkin and subcutaneous tissue disorders | 1/27 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/27 |
| Event | GM-CSF Injections and Oral Thalidomide |
|---|---|
| ConstipationGastrointestinal disorders | 17/27 |
| Injection Site ReactionSkin and subcutaneous tissue disorders | 15/27 |
| FatigueGeneral disorders | 12/27 |
| Solmnolene/DizzinessGeneral disorders | 9/27 |
| Peripheral NeropathyNervous system disorders | 7/27 |
| Age, Continuous(years) | GM-CSF Injections and Oral Thalidomide |
|---|---|
| Median | 59 (44 to 73) |
| Sex: Female, Male(Participants) | GM-CSF Injections and Oral Thalidomide |
|---|---|
| Female | 0 |
| Male | 27 |
| Race (NIH/OMB)(Participants) | GM-CSF Injections and Oral Thalidomide |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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