Phase 2
Completed N=28
GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
Source: ClinicalTrials.gov NCT00400517 ↗Enrolled (actual)
28
Serious AEs
11.1%
Results posted
Aug 2018
Primary outcomePrimary: Proportion of Patients P0 at Surgery — 0 Participants
Summary
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients P0 at Surgery |
— | — |
| PRIMARY Proportion of Patients With Negative Surgical Margins |
— | — |
| PRIMARY Prostate-specific Antigen Response |
22 | — |
| PRIMARY Time to Clinical Progression |
5 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate meeting any of the following criteria for high-risk disease:
- Clinical stage II or III (T2b, T2c, or T3 with any grade or prostate-specific antigen [PSA])
- Gleason score 7 (4+3 only) or ≥ 8 (any stage or PSA)
- Serum PSA ≥ 10 ng/dL (any grade or stage)
- Any stage, PSA, or Gleason score with ≥ 35% chance of biochemical failure at 5 years based on Kattan's nomogram
- No clinical evidence of CNS metastases
- No metastatic disease as demonstrated by radiological exam (CT scan, MRI, bone scan, x-ray) within 8 weeks of study entry
- Appropriate medical candidate for radical prostatectomy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Creatinine ≤ 2.0 mg/dL
- Granulocyte count ≥ 1,800/mm³
- Platelet count ≥ 100,000/mm³
- AST grade 1
- No known HIV positivity
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or controlled Ta transitional cell carcinoma of the bladder
- No known contraindication to sargramostim (GM-CSF) or thalidomide
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the prostate or pelvis
- No prior chemotherapy or hormonal therapy for prostate cancer
- No parenteral antibiotics within the past 7 days
Data sourced from ClinicalTrials.gov (NCT00400517). 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.