Prostate Cancer Clinical Trial
Official title:
Phase I/II Study of Lenalidomide (RevlimidTM ) and GM-CSF in Androgen Independent Prostate Cancer
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:
- Establish the safety of a predetermined target dose or, if the target dose is not
tolerable, find the maximum tolerated dose of lenalidomide when administered in
combination with sargramostim in patients with androgen-independent prostate cancer.
- Evaluate the preliminary efficacy of this regimen to ascertain whether additional study
of lenalidomide is warranted in patients with androgen-independent prostate cancer.
- Evaluate the safety of this regimen in these patients.
- Describe the effects of this regimen on serum cytokines (e.g., TNF-α, bFGF, sIL2R,
IL-8, and IL-12) and on serum VEGF levels.
- Assess the co-stimulatory effects of this regimen on CD4+, CD8+, CD83, and CD86 cells.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
| Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
| Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
| Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
| Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
| Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
| Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
| Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
| Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
| Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
| Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
| Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
| Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |