Clinical trial · Interventional
Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer
A Phase I Study of Repetitive Dosing of Anti-CTLA-4 Antibody (Ipilimumab) in Combination With GM-CSF in Patients With Metastatic, Androgen-Independent Prostate Cancer
NCT00064129CI-TRIAL-00046281completedPhase 1ClinicalTrials.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)
This phase I trial is studying the side effects and best dose of ipilimumab when given with sargramostim in treating patients with metastatic prostate cancer. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system kill more tumor cells.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer AJCC v7 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Biological | Ipilimumab | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (monoclonal antibody, colony-stimulating factors)
- description
- Patients receive ipilimumab IV over 90 minutes on day 1 and sargramostim (GM-CSF) SC on days 1-14. Treatment repeats every 28 days for 4-6 courses. GM-CSF continues beyond 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ipilimumab until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Some patients undergo blood sample collection periodically for laboratory and pharmacokinetic studies. Samples are analyzed for human anti-human antibodies, IgG antibodies to ipilimumab semi-quantitative ELISA assay, and plasma concentrations of ipilimumab via quantitative ELISA assay.
- interventionNames
- Biological: Ipilimumab
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Biological: Sargramostim
Primary outcomes (1)
- measure
- MTD of the combination of ipilimumab with GM-CSF that results in < 33% DLT
- timeFrame
- Continuously
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed prostate cancer
* Metastatic disease
* Progressive disease after prior androgen deprivation as defined by at least 1 of the following criteria:
* Patients with measurable disease must have an increase of at least 20% in the sum of the longest diameter of target lesions OR the appearance of 1 or more new lesions
* Patients with nonmeasurable disease must have a positive bone scan and a prostate-specific antigen (PSA) level of at least 5 ng/mL, which has risen on at least 2 successive occasions at least 2 weeks apart\*
* At least 1 PSA level must be obtained at least 4 weeks after flutamide (6 weeks after bicalutamide or nilutamide)
* Testosterone no greater than 50 ng/dL
* Patients with no prior orchiectomy must continue luteinizing hormone-releasing hormone agonist therapy
* No history or radiologic evidence of CNS metastases
* Performance status - ECOG 0-2
* At least 12 weeks
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 2.5 times ULN
* Creatinine no greater than 1.5 times ULN
* No significant cardiovascular disease
* No New York Heart Association class III or IV congestive heart failure
* No active angina pectoris
* No myocardial infarction within the past 6 months
* Not pregnant or nursing
* Fertile patients must use effective contraception prior to, during, and for 3 months after study participation
* No history of autoimmune disease including, but not limited to, any of the following:
* Autoimmune hemolytic anemia
* Ulcerative and hemorrhagic colitis
* Endocrine disorders (e.g., thyroiditis, hyperthyroidism, hypothyroidism of immune etiology, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency)
* Sarcoid granuloma
* Myasthenia gravis
* Polymyositis
* Guillain-Barre syndrome
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Inflammatory bowel disease
* No other medical or psychiatric illness that would preclude study participation or giving informed consent
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission
* No prior immunotherapy (e.g., vaccines or investigational)
* No other concurrent colony-stimulating factors
* No prior chemotherapy
* No concurrent chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior systemic corticosteroids
* At least 4 weeks since other prior hormonal therapy, including megestrol and finasteride
* No concurrent systemic steroid therapy except inhaled or topical steroids
* No other concurrent hormonal therapy
* Hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed
* At least 4 weeks since prior radiotherapy and recovered
* More than 8 weeks since prior radiopharmaceuticals (e.g., strontium chloride Sr 89 and samarium Sm 153 lexidronam pentasodium)
* Prior irradiation of a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed
* No concurrent palliative radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior herbal products known to decrease PSA levels (e.g., PC-SPES or saw palmetto)References
Publications (2)
- DERIVEDCham J, Zhang L, Kwek S, Paciorek A, He T, Fong G, Oh DY, Fong L. Combination immunotherapy induces distinct T-cell repertoire responses when administered to patients with different malignancies. J Immunother Cancer. 2020 May;8(1):e000368. doi: 10.1136/jitc-2019-000368. PMID 32376721
- DERIVEDKavanagh B, O'Brien S, Lee D, Hou Y, Weinberg V, Rini B, Allison JP, Small EJ, Fong L. CTLA4 blockade expands FoxP3+ regulatory and activated effector CD4+ T cells in a dose-dependent fashion. Blood. 2008 Aug 15;112(4):1175-83. doi: 10.1182/blood-2007-11-125435. Epub 2008 Jun 3. PMID 18523152