Clinical trial · Interventional
Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer
Phase I/II Study of Lenalidomide (RevlimidTM ) and GM-CSF in Androgen Independent Prostate Cancer
NCT00939510CI-TRIAL-00009233completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| lenalidomide | Drug | Lenalidomide | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide (RevlimidTM ) and GM-CSF
- interventionNames
- Biological: sargramostim
- Drug: lenalidomide
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Number of Patients With a PSA Response
- timeFrame
- reevaluated for response every eight weeks
- description
- Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.
- measure
- RECIST-defined Measurable Disease
- timeFrame
- every 8 weeks and at end of treatment
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 \< 3 times normal
* Bilirubin \< 1.5 mg/dL
* PT and PTT normal
* Calcium normal
* Fertile patients must use effective contraception during and for ≥ 28 days after completion of study therapy
* Agrees to abstain from donating blood, semen, or sperm during and for ≥ 28 days after completion of study therapy
* No pre-existing peripheral neuropathy \> 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 thalidomideReferences
Publications (0)
Data not yet available
No reference posted for this study.