Trial Outcomes & Findings for Melanoma Vaccine With Peptides and Leuprolide (NCT NCT00254397)

Last Updated: 2019-10-16

Results Overview

Reactivity to the gp100 peptide in each participant defined as \>10 tetramer positive cells per 10\^4 CD8+ T-cells as determined by the tetramer analysis at 3 months following initial vaccine. Number of participants with response as defined reported. The primary end point of this clinical study was the comparison of tumor-specific immune responses to melanoma-specific peptide vaccines, gp100 and MAGE-3 in the presence or absence of Leuprolide. Gp209-2M/HLA-A\*0201 tetramers that are commercially available employed to analyze levels of gp209-2M specific CD8+ cytolytic T cells. The levels of peptide/ HLA-A\*0201 tetramer between participants' peripheral blood mononuclear cells (PBMCs) with Leuprolide injection and without Leuprolide injection compared.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

98 participants

Primary outcome timeframe

At 3 months following initial vaccine.

Results posted on

2019-10-16

Participant Flow

Dates of Recruitment Period: November 8, 2005 to August 11, 2009. All participants recruited the University of Texas (UT) MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	gp100 + Leuprolide Group IA: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).	gp100 - No Leuprolide Group IB: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide	gp100 + MAGE-3 + Leuprolide Group IIA: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).	gp100 + MAGE-3 - No Leuprolide Group IIB: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide
Overall Study STARTED	10	6	37	45
Overall Study COMPLETED	4	5	18	20
Overall Study NOT COMPLETED	6	1	19	25

Reasons for withdrawal

Reasons for withdrawal
Measure	gp100 + Leuprolide Group IA: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).	gp100 - No Leuprolide Group IB: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide	gp100 + MAGE-3 + Leuprolide Group IIA: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).	gp100 + MAGE-3 - No Leuprolide Group IIB: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide
Overall Study Disease Progression	4	1	16	23
Overall Study Non-Compliant	0	0	0	1
Overall Study Adverse Event	2	0	3	1

Baseline Characteristics

Melanoma Vaccine With Peptides and Leuprolide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	gp100 + Leuprolide n=10 Participants Group IA: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).	gp100 - No Leuprolide n=6 Participants Group IB: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide	gp100 + MAGE-3 + Leuprolide n=37 Participants Group IIA: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)).	gp100 + MAGE-3 - No Leuprolide n=45 Participants Group IIB: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	5 Participants n=7 Participants	27 Participants n=5 Participants	31 Participants n=4 Participants	72 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants	26 Participants n=21 Participants
Age, Continuous	48.5 years n=5 Participants	43.5 years n=7 Participants	55 years n=5 Participants	54 years n=4 Participants	53 years n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants	18 Participants n=4 Participants	35 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	26 Participants n=5 Participants	27 Participants n=4 Participants	63 Participants n=21 Participants
Region of Enrollment United States	10 participants n=5 Participants	6 participants n=7 Participants	37 participants n=5 Participants	45 participants n=4 Participants	98 participants n=21 Participants

PRIMARY outcome

Timeframe: At 3 months following initial vaccine.

Population: Although all participants did not receive all doses of the vaccine due to tumor progression and other reasons, if samples were available after two or more vaccinations, analyses were performed.

Outcome measures

Outcome measures
Measure	gp100 + Leuprolide n=7 Participants Group IA: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)). Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections). GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 - No Leuprolide n=4 Participants Group IB: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 + MAGE-3 + Leuprolide n=26 Participants Group IIA: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)). Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections). GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities. MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 + MAGE-3 - No Leuprolide n=33 Participants Group IIB: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities. MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities.
Number of Participants With T-cell Response to Peptide Vaccine	6 Participants	1 Participants	12 Participants	19 Participants

SECONDARY outcome

Timeframe: Baseline up to 48 weeks during vaccine treatment

Population: Although our immunologic analysis was based on participants HLA type in order to determine reactivity against particular peptides, all participants received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed participants within these two groups.

Summary of most frequent adverse events collected study wide during vaccine treatment period using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).

Outcome measures

Outcome measures
Measure	gp100 + Leuprolide n=47 Participants Group IA: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)). Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections). GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 - No Leuprolide n=51 Participants Group IB: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 + MAGE-3 + Leuprolide Group IIA: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)). Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections). GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities. MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 + MAGE-3 - No Leuprolide Group IIB: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities. MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities.
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Atrial fibrillation	2 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Elevated Creatinine	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Hyperglycemia	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Cardiac troponin T	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Cardiac Ischema	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Fatigue	15 occurences	7 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Hypotension	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Ruptured lumbar disc	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Possible Metastatic Lung Nodule	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Cellulitis	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Cerebral Ischemia	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Cardiac Ischemia/stent	1 occurences	0 occurences	—	—
Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study Multiple Allergic Reactions	1 occurences	0 occurences	—	—

SECONDARY outcome

Timeframe: Baseline up to 48 weeks during vaccine treatment

Population: Only 91 participants' data was available for classification in analysis.

Maximum Grade reported for participant adverse events. collected study wide during vaccine treatment period using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).

Outcome measures

Outcome measures
Measure	gp100 + Leuprolide n=10 Participants Group IA: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)). Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections). GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 - No Leuprolide n=4 Participants Group IB: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 + MAGE-3 + Leuprolide n=36 Participants Group IIA: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)). Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections). GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities. MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 + MAGE-3 - No Leuprolide n=41 Participants Group IIB: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities. MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities.
Number of Participants Experiencing Adverse Events by Maximum Grade Within Different Arms Grade 4-Life threatening or disabling	0 participants	0 participants	1 participants	0 participants
Number of Participants Experiencing Adverse Events by Maximum Grade Within Different Arms Grade 3-Severe	2 participants	0 participants	0 participants	3 participants
Number of Participants Experiencing Adverse Events by Maximum Grade Within Different Arms Grade 2-Moderate	5 participants	2 participants	21 participants	10 participants
Number of Participants Experiencing Adverse Events by Maximum Grade Within Different Arms Grade 1-Mild	2 participants	2 participants	7 participants	24 participants

SECONDARY outcome

Timeframe: Baseline up to 48 weeks during vaccine treatment

Summary of adverse events( AE) collected during vaccine treatment period using Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grade 0-Sign/symptom within normal limits, Grade 1-Mild AE, Grade 2-Moderate AE, Grade 3-Severe AE, Grade 4- Life threatening or disabling AE.

Outcome measures

Outcome measures
Measure	gp100 + Leuprolide n=10 Participants Group IA: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)). Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections). GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 - No Leuprolide n=6 Participants Group IB: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 + MAGE-3 + Leuprolide n=37 Participants Group IIA: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) + Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)). Leuprolide: A 3-month 11.25 mg sustained-release formulation will be administrated intramuscularly at time 0, and approximately 12 weeks (2 injections). GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities. MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities.	gp100 + MAGE-3 - No Leuprolide n=45 Participants Group IIB: HLA-A\*0201positive/HLA-DP4 positive treated with gp100 (1.0 ml subcutaneous injection in extremities) + MAGE-3 (1.0 ml subcutaneous injection in extremities) - No Leuprolide GP100: 209-217(210M) Peptide: 1.0 ml subcutaneous injection in extremities. MAGE-3 Peptide: 1.0 ml subcutaneous injection in extremities.
Summary of Adverse Events by Grade/Relationship Grade 1, Possible	22 occurences	6 occurences	103 occurences	74 occurences
Summary of Adverse Events by Grade/Relationship Grade 1, Probable	13 occurences	3 occurences	53 occurences	56 occurences
Summary of Adverse Events by Grade/Relationship Grade 1, Unlikely	16 occurences	4 occurences	25 occurences	38 occurences
Summary of Adverse Events by Grade/Relationship Grade 1, Unrelated	15 occurences	3 occurences	45 occurences	36 occurences
Summary of Adverse Events by Grade/Relationship Grade 1, Unspecified Relationship	29 occurences	7 occurences	61 occurences	37 occurences
Summary of Adverse Events by Grade/Relationship Grade 0, Possible	1 occurences	0 occurences	0 occurences	0 occurences
Summary of Adverse Events by Grade/Relationship Grade 0, Probable	2 occurences	0 occurences	0 occurences	0 occurences
Summary of Adverse Events by Grade/Relationship Grade 0, Unlikely	0 occurences	0 occurences	2 occurences	0 occurences
Summary of Adverse Events by Grade/Relationship Grade 0, Unrelated	0 occurences	0 occurences	0 occurences	0 occurences
Summary of Adverse Events by Grade/Relationship Grade 3, Unrelated	0 occurences	0 occurences	0 occurences	1 occurences
Summary of Adverse Events by Grade/Relationship Grade 2, Probable	5 occurences	0 occurences	3 occurences	1 occurences
Summary of Adverse Events by Grade/Relationship Grade 0, Unspecified Relationship	2 occurences	0 occurences	5 occurences	13 occurences
Summary of Adverse Events by Grade/Relationship Grade 4, Unspecified Relationship	0 occurences	0 occurences	1 occurences	0 occurences
Summary of Adverse Events by Grade/Relationship Grade 3, Possible	1 occurences	0 occurences	0 occurences	1 occurences
Summary of Adverse Events by Grade/Relationship Grade 3, Probable	1 occurences	0 occurences	0 occurences	0 occurences
Summary of Adverse Events by Grade/Relationship Grade 3, Unspecified Relationship	0 occurences	0 occurences	0 occurences	1 occurences
Summary of Adverse Events by Grade/Relationship Grade 2, Definite	5 occurences	0 occurences	11 occurences	0 occurences
Summary of Adverse Events by Grade/Relationship Grade 2, Possible	3 occurences	1 occurences	19 occurences	3 occurences
Summary of Adverse Events by Grade/Relationship Grade 2, Unlikely	0 occurences	0 occurences	2 occurences	3 occurences
Summary of Adverse Events by Grade/Relationship Grade 2, Unrelated	3 occurences	1 occurences	1 occurences	4 occurences
Summary of Adverse Events by Grade/Relationship Grade 2, Unspecified Relationship	8 occurences	1 occurences	16 occurences	7 occurences
Summary of Adverse Events by Grade/Relationship Grade 1, Definite	21 occurences	4 occurences	61 occurences	50 occurences

Adverse Events

gp100, Leuprolide, MAGE-3

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

gp100 + No Leuprolide

Serious events: 3 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	gp100, Leuprolide, MAGE-3 n=47 participants at risk HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) with/without Leuprolide (3-month 11.25 mg sustained-release formulation administrated intramuscularly then again 12 weeks later (2 injections)); with/without MAGE-3 (1.0 ml subcutaneous injection in extremities)	gp100 + No Leuprolide n=51 participants at risk HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) without Leuprolide; with/without MAGE-3 (1.0 ml subcutaneous injection in extremities)
Cardiac disorders Cardiac Ischemia/ Infarction	2.1% 1/47 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.	0.00% 0/51 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.
Hepatobiliary disorders Cholecystitis	0.00% 0/47 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.	2.0% 1/51 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.
General disorders Fatigue	2.1% 1/47 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.	0.00% 0/51 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/47 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.	2.0% 1/51 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.
Blood and lymphatic system disorders Neutrophils Elevated	0.00% 0/47 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.	2.0% 1/51 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.
Nervous system disorders Pain (Head/Headache)	2.1% 1/47 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.	0.00% 0/51 • Participants evaluated every 6 weeks up to 48 weeks during the vaccine treatment phase of the study. Active study participation period: November 2005 to October 2010 (last participant off study). Although our immunologic analysis was based on patient HLA type in order to determine reactivity against particular peptides, all patients received vaccines with or without leuprolide. Therefore, in assessing toxicity we analyzed patients within these two groups.

Other adverse events

Additional Information

Patrick Hwu, MD / Professor, Melanoma Medical Oncology

University of Texas MD Anderson Cancer Center

Phone: 713-792-2921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place