Clinical trial · Interventional
Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer
Phase II Study of Granulocyte-Macrophage Colony Stimulating Factor Plus Mitoxantrone for the Treatment of Hormone Refractory Prostate Cancer
NCT00477087CI-TRIAL-00030576terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory 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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Drug | — | UNRESOLVED |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GM-CSF Plus Mitoxantrone
- description
- GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days.
- interventionNames
- Drug: Mitoxantrone
- Drug: GM-CSF
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- 18 months
- description
- Assessed as the time from the 1st dose of study drug to death or disease progression (increase \>25% over baseline PSA on 2 consecutive measurements 2 weeks apart, need for palliative therapy, formation/progression of new bone lesions, or decline of \>20% KPS)
Secondary outcomes (2)
- measure
- Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent * Age ≥ 18 years * Histologically-confirmed adenocarcinoma of the prostate * Hormone-refractory prostate cancer * Failed 1st-line docetaxel-containing regimen * No prior immunotherapy including: * Vaccines * GM-CSF * Minimum prostate-specific antigen (PSA) \> 5 mg/dL and rising according to the PSA Consensus Criteria * Karnofsky Performance Status (KPS) \> 60% * Eastern Cooperative Oncology Group (ECOG) Performance Status \< 3 * Life expectancy \> 6 months Exclusion Criteria: * Concomitant hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonist * Use of herbal products known to decrease PSA levels * Use of supplements or complementary medicines, except for: * Conventional multivitamin supplements * Selenium * Lycopene * Soy supplements * Vitamin E * Initiation of bisphosphonates within one month prior to enrollment or throughout the study * Any prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment * Major surgery or radiation therapy completed \< 4 weeks prior to enrollment * Any concomitant second malignancy other than non-melanoma skin cancer * Any concomitant serious infection * Any nonmalignant medical illness * Absolute neutrophil count (ANC) \< 1,500/µL * Platelet count \< 100,000 µL * Hemoglobin \< 8 mg/dL * Total bilirubin greater than 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x ULN if no demonstrable liver metastases, or greater than 5.0 x ULN in presence of liver metastases * Ejection fraction \< 50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan * Noncompliance with study procedures
References
Publications (0)
Data not yet available
No reference posted for this study.