A Phase 1/2 interventional study of sargramostim and lenalidomide in Prostate Cancer, sponsored by Robert Dreicer MD. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-31.
Sponsored by Robert Dreicer MD · Phase 1/2, Interventional, and Treatment
RATIONALE: Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing. Giving lenalidomide together with GM-CSF may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with GM-CSF and to see how well it works in treating patients with prostate cancer.
OBJECTIVES:
OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study.
Patients receive oral lenalidomide on days 1-21 and sargramostim subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative biomarker and immunological laboratory studies.
After completion of study therapy, patients are followed up at 30 days and then every 3 months thereafter.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 32 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Robert Dreicer MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Androgen-independent disease
Testosterone ≤ 50 ng/mL
Progressive disease, as defined by ≥ 1 of the following:
Asymptomatic (non-opioid requiring) bone-only metastatic disease with a rising PSA on separate measurements ≥ 1 week apart
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No initiation of bisphosphonate therapy within 1 month before and during study therapy
Concurrent daily aspirin for the prevention of thrombotic events required
Biological: sargramostim · Drug: lenalidomide · Other: laboratory biomarker analysis
All patients will receive GM-CSF at a dose of 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week. No dose escalation or de-escalations will be made to GM-CSF.
Also known as: GM-CSF
Lenalidomide will be administered at 25 mg/day orally on days 1-21 of a 28-day cycle. Initially 6 patients will be entered at the 25 mg/day level. If 0 or 1 patients have a dose limiting toxicity, then the 25 mg lenalidomide + GM-CSF 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week will be accepted as the phase II dose.
Prior to the initiation of each cycle of therapy for the first 3 cycles, and at discontinuation from study blood will be collected for assessments of a prostate cancer specific immune response.
Number of Patients With a PSA Response
Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.
Time frame: reevaluated for response every eight weeks
RECIST-defined Measurable Disease
Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks
Time frame: every 8 weeks and at end of treatment
Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study
The change in mean T cell immunohistochemical markers and dendritic cells over time will be evaluated using analysis of variance methods for repeated measures with additional main factors included in the analysis for subset comparisons. The pattern of immune response will be evaluated based upon overall clinical response using these same techniques.
Time frame: every 28 days for first 3 cycles, end of study
Patients were recruited from November 2005 to April 2009 from medical clinic
| Milestone | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| Started | 32 |
| Completed | 31 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.
| participants | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| PSA response | 4 |
| PSA no response | 27 |
The change in mean T cell immunohistochemical markers and dendritic cells over time will be evaluated using analysis of variance methods for repeated measures with additional main factors included in the analysis for subset comparisons. The pattern of immune response will be evaluated based upon overall clinical response using these same techniques.
| participants | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study | 0 |
Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks
| participants | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| Number of patients with stable disease (SD) | 4 |
| Number of patients with partial response (PR) | 2 |
| Number of patients with progressive disease | 5 |
Collected over Patients followed for adverse events while on study over a three year period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lenalidomide (Revlimid) and Sargramostim (GM-CSF) | — | 5/31 (16.1%) | 31/31 (100%) |
| Event | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| NeutropeniaBlood and lymphatic system disorders | 3/31 |
| Elevated Lactate dehydrogenase (LDH)Investigations | 2/31 |
| Deep Venous Thrombosis (DVT)/EmbolismCardiac disorders | 1/31 |
| LeukopeniaBlood and lymphatic system disorders | 1/31 |
| Event | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| FatigueGeneral disorders | 22/31 |
| Injection site reactionsGeneral disorders | 17/31 |
| ThrombocytopeniaBlood and lymphatic system disorders | 17/31 |
| Skin (dryness, rash, pruritus)Skin and subcutaneous tissue disorders | 16/31 |
| AnemiaBlood and lymphatic system disorders | 15/31 |
| LymphopeniaInvestigations | 12/31 |
| NeutropeniaCardiac disorders | 12/31 |
| LeukopeniaBlood and lymphatic system disorders | 11/31 |
| Nausea/VomitingGastrointestinal disorders | 11/31 |
| ConstipationGastrointestinal disorders | 10/31 |
| Age Continuous(years) | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| Mean | 68.7 ± 7.3 |
| Sex: Female, Male(Participants) | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| Female | 0 |
| Male | 32 |
| Ethnicity (NIH/OMB)(Participants) | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 29 |
| Unknown or Not Reported | 3 |
| Race (NIH/OMB)(Participants) | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Lenalidomide (Revlimid) and Sargramostim (GM-CSF) |
|---|---|
| United States | 32 |
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