Trial · NCT00071981

Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma

NCT00071981, Phase 2, Completed, Eastern Cooperative Oncology Group; results first posted 2013-01-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma. Trials, record NCT00071981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00071981

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma
NCT number: NCT00071981
Status: Completed
Phases: Phase 2
Enrollment: 175 participants, actual
Lead sponsor: Eastern Cooperative Oncology Group
Conditions: Melanoma (Skin)
Interventions: incomplete Freund's adjuvant, melanoma helper peptide vaccine, multi-epitope melanoma peptide vaccine, sargramostim, tetanus peptide melanoma vaccine
First posted: 2003-11-06
Last updated: 2023-06-28
Results first posted: 2013-01-03

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cytotoxic T-cell Lymphocytes (CTL) Response Rate	Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8	Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.
Secondary	Helper T-cells Response to 6MHP	Immune response was assessed at pre-registration, in weeks 1,3,5,7,8	Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.
Secondary	Helper T Cell Response to Tetanus	Immune response was assessed at pre-registration, in weeks 1,3,5,7,8	Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.
Secondary	Objective Response Rate	Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccination	Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate is calculated as the number of patients with complete response (disappearance of all lesions) or partial response () divided by total number of evaluable patients.
Secondary	Median Overall Survival (OS)	assessed every 3 month within 2 years and every 6 months betwen 2 and 5 years	OS was defined as the time from registration to death from any cause.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cytotoxic T-cell Lymphocytes (CTL) Response Rate	Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8	140 eligible and treated patients who had CTL response data were included in the analysis	percentage of participants	NUMBER
SECONDARY	Helper T-cells Response to 6MHP	Immune response was assessed at pre-registration, in weeks 1,3,5,7,8	128 eligible and treated patients who had data about helper T cell response were included in the analysis	percentage of participants	NUMBER
SECONDARY	Helper T Cell Response to Tetanus	Immune response was assessed at pre-registration, in weeks 1,3,5,7,8	128 eligible and treated patients who had data about HTL response to tetanus peptide were included in the analysis	percentage of participants	NUMBER
SECONDARY	Objective Response Rate	Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccination	148 eligible and treated patients were included in the analysis	percentage of participants	NUMBER
SECONDARY	Median Overall Survival (OS)	assessed every 3 month within 2 years and every 6 months betwen 2 and 5 years	148 eligible and treated patients were included in the analysis	months	MEDIAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Cytotoxic T-cell Lymphocytes (CTL) Response Rate	Arm I (12MP)	43	95% Confidence Interval 27 to 59	percentage of participants
Cytotoxic T-cell Lymphocytes (CTL) Response Rate	Arm II (12MP/Tet)	47	95% Confidence Interval 28 to 66	percentage of participants
Cytotoxic T-cell Lymphocytes (CTL) Response Rate	Arm III (12MP/6MHP)	28	95% Confidence Interval 13 to 47	percentage of participants
Cytotoxic T-cell Lymphocytes (CTL) Response Rate	Arm IV (6MHP)	5	95% Confidence Interval 0.6 to 16.5	percentage of participants
Helper T-cells Response to 6MHP	Arm I (12MP)	3	95% Confidence Interval 0 to 14	percentage of participants
Helper T-cells Response to 6MHP	Arm II (12MP/Tet)	0	95% Confidence Interval 0 to 13	percentage of participants
Helper T-cells Response to 6MHP	Arm III (12MP/6MHP)	40	95% Confidence Interval 21 to 61	percentage of participants
Helper T-cells Response to 6MHP	Arm IV (6MHP)	41	95% Confidence Interval 26 to 58	percentage of participants
Helper T Cell Response to Tetanus	Arm I (12MP)	11	95% Confidence Interval 3 to 25	percentage of participants
Helper T Cell Response to Tetanus	Arm II (12MP/Tet)	59	95% Confidence Interval 39 to 79	percentage of participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow32

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (12MP)	47
Overall Study	STARTED	Arm II (12MP/Tet)	43
Overall Study	STARTED	Arm III (12MP/6MHP)	37
Overall Study	STARTED	Arm IV (6MHP)	48
Overall Study	Eligible	Arm I (12MP)	43
Overall Study	Eligible	Arm II (12MP/Tet)	36
Overall Study	Eligible	Arm III (12MP/6MHP)	33
Overall Study	Eligible	Arm IV (6MHP)	42
Overall Study	Treated	Arm I (12MP)	45
Overall Study	Treated	Arm II (12MP/Tet)	38

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events212

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Leukopenia (Leukocytes decreased)	Investigations	Arm I (12MP)	3	45
other	Leukopenia (Leukocytes decreased)	Investigations	Arm II (12MP/Tet)	5	38
other	Leukopenia (Leukocytes decreased)	Investigations	Arm III (12MP/6MHP)	1	36
other	Leukopenia (Leukocytes decreased)	Investigations	Arm IV (6MHP)	0	48
other	Lymphopenia	Investigations	Arm I (12MP)	2	45
other	Lymphopenia	Investigations	Arm II (12MP/Tet)	8	38
other	Lymphopenia	Investigations	Arm III (12MP/6MHP)	6	36
other	Lymphopenia	Investigations	Arm IV (6MHP)	4	48
other	Neutropenia (Neutrophils decreased)	Investigations	Arm I (12MP)	0	45
other	Neutropenia (Neutrophils decreased)	Investigations	Arm II (12MP/Tet)	2	38

1 to 10 of 212Source ClinicalTrials.gov

See all 212 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (12MP)
Total, all-cause mortality	Arm II (12MP/Tet)
Total, all-cause mortality	Arm III (12MP/6MHP)
Total, all-cause mortality	Arm IV (6MHP)
Total, other adverse events	Arm I (12MP)	36	45
Total, other adverse events	Arm II (12MP/Tet)	28	38
Total, other adverse events	Arm III (12MP/6MHP)	28	36
Total, other adverse events	Arm IV (6MHP)	33	48
Total, serious adverse events	Arm I (12MP)	6	45
Total, serious adverse events	Arm II (12MP/Tet)	9	38

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA021115	Eastern Cooperative Oncology Group Operations Office	COMIS, ROBERT L	FRONTIER SCI & TECHNOLOGY RSCH FDN, INC	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00071981

GET https://conductscience.org/api/trials/v1/NCT00071981/flow?page=2

API reference For AI assistants