Colon Cancer, Rectal Cancer
Conditions
Keywords
Metastatic colon cancer, Metastatic rectal cancer
Brief summary
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.
Interventions
DRUGGM-CSF
250ug/m\^2 SQ QD with a cap of 500mcg SQ QD
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Exhibiting Immune Response | 24 Months | Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rates and Overall Survival. | 24 Months | Effect of cellular immune stimulation on response rates and overall survival. This is a secondary endpoint and while data will be recorded, a larger study with improved power will be necessary to confirm any improvements noted. |
Countries
United States
Participant flow
Recruitment details
20 subjects enrolled between Jun 2003 and Jan 2007 in UCIMC location. All subjects undergoing treatment are presented with all options for their care - research or non-research.
Pre-assignment details
Subjects with known allergic or other adverse reaction to GM-CSF are excluded from study. Also pregnant and lactating women were excluded from study.
Participants by arm
| Arm | Count |
|---|---|
| Chemo Therapy and GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Chemo Therapy and GM-CSF |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 62.65 years STANDARD_DEVIATION 13.52 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Participants Exhibiting Immune Response
Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.
Time frame: 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chemo Therapy and GM-CSF | Participants Exhibiting Immune Response | 11 Participants |
Secondary
Response Rates and Overall Survival.
Effect of cellular immune stimulation on response rates and overall survival. This is a secondary endpoint and while data will be recorded, a larger study with improved power will be necessary to confirm any improvements noted.
Time frame: 24 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chemo Therapy and GM-CSF | Response Rates and Overall Survival. | Response Rates | 16 Participants |
| Chemo Therapy and GM-CSF | Response Rates and Overall Survival. | Overall Survival | 16 Participants |