Trial · NCT00977145
Evaluating the Safety and the Biological Effects of Intratumoral Interferon Gamma and a Peptide-Based Vaccine in Patients With Melanoma
NCT00977145, Phase 1, Terminated, Craig L Slingluff, Jr
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating the Safety and the Biological Effects of Intratumoral Interferon Gamma and a Peptide-Based Vaccine in Patients With Melanoma. Trials, record NCT00977145. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00977145
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Safety and the Biological Effects of Intratumoral Interferon Gamma and a Peptide-Based Vaccine in Patients With Melanoma
- NCT number
- NCT00977145
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- Craig L Slingluff, Jr
- Conditions
- Melanoma
- Interventions
- A combination of intratumoral IFN-gamma plus systemic vaccination with MELITAC 12.1
- First posted
- 2009-09-15
- Last updated
- 2016-12-16
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: To determine the safety of administration of intratumoral interferon gamma with a peptide-based vaccine in patients with cutaneous or subcutaneous metastases of melanoma. | 6 months | |
| Primary | Biologic effect: To evaluate the biological effects of vaccine plus IFN-gamma at the tumor site, to include expression of CXCR3 ligands (CXCL9, CXCL10 & CXCL11) and the magnitude of infiltration of CD8+ CXCR3+ T cells and vaccine-specific T cells. | 6 months | |
| Secondary | To estimate the effects of vaccine on CXCR3 expression by circulating antigen-experienced CD4 and CD8 T cells. | 6 months | |
| Secondary | To estimate the effects of vaccine plus IFN-gamma on changes in the percentage of FoxP3+ CD25hi CD4+ (putative regulatory T cells, T regulatory cells) among tumor infiltrating T cells. | 6 months | |
| Secondary | To obtain preliminary data on the variability of immunologic parameters among multiple biopsies of subcutaneous or cutaneous metastases of melanoma. | 6 months | |
| Secondary | To obtain preliminary data on the clinical response of cutaneous or subcutaneous metastases of melanoma to the proposed combination regimen. | 6 months |
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 |
|---|---|
| 36746511 | DERIVED |
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/NCT00977145
GET https://conductscience.org/api/trials/v1/NCT00977145/registered