Trial · NCT00350597
GM-CSF as Adjuvant Therapy of Melanoma
NCT00350597, Phase 2, Completed, Northern California Melanoma Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GM-CSF as Adjuvant Therapy of Melanoma. Trials, record NCT00350597. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00350597
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GM-CSF as Adjuvant Therapy of Melanoma
- NCT number
- NCT00350597
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants
- Lead sponsor
- Northern California Melanoma Center
- Conditions
- Malignant Melanoma
- Interventions
- Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
- First posted
- 2006-07-11
- Last updated
- 2006-07-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1 To describe the effect of GM-CSF adjuvant treatment of 125 ug/m2 once daily for 14 days followed by 14 days rest on immunological function as determined by serum neopterin levels (a measure of macrophage activation) and on serum levels of S100B. | ||
| Secondary | To evaluate if a change of any or all of the immunological parameters over the treatment period is associated with safety and/or clinical outcome as measured by time to disease recurrence, time to disseminated disease and/or survival. | ||
| Secondary | To perform a more detailed immunologic analysis in a sub-set of study participants (6 evaluable patients) to determine the immunologic responses induced by GM-CSF. There are three main immunological analyses to be determined: | ||
| Secondary | a Monocyte cell numbers and activity | ||
| Secondary | b Mature dendritic cell numbers | ||
| Secondary | c Surface markers on peripheral blood mononuclear cells (PBMC) relative to T cells |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 10764421 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00350597
GET https://conductscience.org/api/trials/v1/NCT00350597/registered