Phase 2
Completed N=32
Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer
Source: ClinicalTrials.gov NCT00939510 ↗Enrolled (actual)
32
Serious AEs
16.1%
Results posted
Jul 2012
Primary outcomePrimary: Number of Patients With a PSA Response — 4; 27 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With a PSA Response |
4; 27 | — |
| PRIMARY RECIST-defined Measurable Disease |
4; 2; 5 | — |
| SECONDARY Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study |
— | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Androgen-independent disease
- Testosterone ≤ 50 ng/mL
- Is currently receiving luteinizing hormone-releasing hormone agonists as maintenance or has undergone prior orchiectomy for testosterone suppression
- Progressive disease, as defined by ≥ 1 of the following:
- Clinical or radiographic evidence of metastases that have progressed irrespective of PSA changes
- Asymptomatic (non-opioid requiring) bone-only metastatic disease with a rising PSA on separate measurements ≥ 1 week apart
- No symptomatic bone metastases
- Biochemical progression (PSA-only disease), defined as having an absolute PSA value of ≥ 2.0 ng/mL on 3 separate measurements ≥ 2 weeks apart with a PSA doubling time of ≤ 10 months
- No evidence of CNS (brain or leptomeningeal) metastases or pleural and/or pericardial effusions
PATIENT CHARACTERISTICS:
- ECOG performance status of 0-1
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Serum creatinine ≤ 2.0 mg/dL
- AST grade 1
- No active unresolved infection
- No known contraindication to lenalidomide or sargramostim
- No other malignancies within the past 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or stage Ta transitional cell carcinoma of the bladder
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy for metastatic prostate cancer
- More than 1 year since prior adjuvant and/or neoadjuvant therapy
- More than 4 weeks since prior flutamide (6 weeks for other antiandrogens)
- No prior thalidomide or lenalidomide
- At least 4 weeks since prior surgery or external-beam radiotherapy and recovered
- At least 6 weeks since prior radiopharmaceutical therapy, including samarium-153 or strontium-89, and recovered
- No initiation of bisphosphonate therapy within 1 month before and during study therapy
- Patients on stable doses of bisphosphonates who show subsequent tumor progression may continue to receive bisphosphonates
- Concurrent daily aspirin for the prevention of thrombotic events required
- Patients intolerant to aspirin may receive low-dose warfarin as prophylaxis
- No other concurrent investigational agents
- No other concurrent anticancer therapy, including radiotherapy or thalidomide
Data sourced from ClinicalTrials.gov (NCT00939510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.