Clinical trial · Interventional
Cellular Immune Augmentation in Colon and Rectal Cancer
A Pilot Study of Cellular Immune Augmentation in Colon and Rectal Cancer Therapy
- 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)
While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GM-CSF
- description
- Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD
- interventionNames
- Drug: GM-CSF
Primary outcomes (1)
- measure
- Participants Exhibiting Immune Response
- timeFrame
- 24 Months
- description
- Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.
Secondary outcomes (1)
- measure
- Response Rates and Overall Survival.
- timeFrame
- 24 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have: metastatic, disseminated or recurrent colon or rectal cancer * Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent) given once weekly 5FU/leucovorin/irinotecan given once weekly * Patient must be able to be taught to administer GM-CSF subcutaneously Exclusion criteria: * Known allergic or other adverse reaction to GM-CSF * Chemotherapy administration more frequently than bi-weekly * Pregnant or lactating women
References
Publications (1)
- DERIVEDMartinez M, Ono N, Planutiene M, Planutis K, Nelson EL, Holcombe RF. Granulocyte-macrophage stimulating factor (GM-CSF) increases circulating dendritic cells but does not abrogate suppression of adaptive cellular immunity in patients with metastatic colorectal cancer receiving chemotherapy. Cancer Cell Int. 2012 Jan 23;12(1):2. doi: 10.1186/1475-2867-12-2. PMID 22270330