Clinical trial · Interventional
GM-CSF and Thalidomide in Treating Patients Undergoing Surgery for High-Risk Prostate Cancer
Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy
- 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: 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.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GM-CSF Injections and Oral Thalidomide
- description
- taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.
- interventionNames
- Biological: sargramostim
- Drug: thalidomide
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
Primary outcomes (4)
- measure
- Proportion of Patients P0 at Surgery
- timeFrame
- 8 weeks
- description
- Pathologic Complete Response is defined as complete eradication of tumor.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 120 Years
Show eligibility criteria text
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 \< 3 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL * Fertile patients must use effective contraception during and for 4 weeks after completion of study treatment * No active unresolved infection * No pre-existing peripheral neuropathy \> 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
References
Publications (0)
Data not yet available