Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer
| Status: | Archived |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2005 |
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.
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