Trial · Interventional

CompletedPhase 2Results postedRegistry data

Melanoma Vaccine With Peptides and Leuprolide

NCTNCT00254397Other id2004-0502

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 98 participants (actual)
Sponsor: M.D. Anderson Cancer Center · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Nov 2005
Primary completion: Oct 2012
Completion: Oct 2012
First posted: 16 Nov 2005 (estimated)
Last update posted: 16 Oct 2019
Conditions: Melanoma

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2006200820102012

Ph 2
Melanoma Vaccine With Peptides and Leuprolide
NCT00254397
Nov 2005 to Oct 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The goal of this clinical research study is to learn if the drug leuprolide will increase the level of immune cells in your body. Researchers will also want to know if this drug given together with melanoma vaccines (gp100 and MAGE-3) can improve the ability of tumor fighting immune cells (T cells) to fight melanoma cells. Primary Objective: 1\. To compare the tumor-specific immune responses to melanoma-specific peptide vaccines, gp100 and MAGE-3 in the presence or absence of a luteinizing hormone-releasing hormone (LHRH) agonist-Leuprolide, in patients with stage IIb and III melanoma, uveal melanoma or stage IV melanoma that the metastatic lesion(s) has been surgically removed. Secondary Objectives: 1. To evaluate the kinetics of enhanced thymic activity measured by TREC analysis and flow cytometric analysis following sex hormone ablation by Leuprolide in melanoma patients. 2. To assess whether there are significant differences in overall quality of life (QOL) between patients receiving Leuprolide to those not receiving leuprolide.

Interventions

LeuprolideDrug
GP100: 209-217(210M) PeptideBiological
MAGE-3 PeptideBiological

Arms4

Experimental
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)).
Experimental
gp100 - No Leuprolide
Group IB: HLA-A\*0201 positive/HLA-DP4 negative treated with gp100 (1.0 ml subcutaneous injection in extremities) - No Leuprolide
Experimental
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)).
Experimental
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With T-cell Response to Peptide Vaccine
Time frame · At 3 months following initial vaccine.
Registry description
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.

Secondary outcomes(3)

Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study
Time frame · Baseline up to 48 weeks during vaccine treatment
Registry description
Summary of most frequent adverse events collected study wide during vaccine treatment period using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Number of Participants Experiencing Adverse Events by Maximum Grade Within Different Arms
Time frame · Baseline up to 48 weeks during vaccine treatment
Registry description
Maximum Grade reported for participant adverse events. collected study wide during vaccine treatment period using Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Summary of Adverse Events by Grade/Relationship
Time frame · Baseline up to 48 weeks during vaccine treatment
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· At 3 months following initial vaccine.

Number of Participants With T-cell Response to Peptide Vaccine

Group	Value (Participants)
gp100 + Leuprolide	6
gp100 - No Leuprolide	1
gp100 + MAGE-3 + Leuprolide	12
gp100 + MAGE-3 - No Leuprolide	19

Secondary and other outcome results(3)

Secondary outcomeNumber· Baseline up to 48 weeks during vaccine treatment

Most Frequent and Most Serious Participant Adverse Events During Vaccine Treatment for Overall Study

Group	Value (occurences)
gp100 + Leuprolide	1
gp100 + No Leuprolide	0

Secondary outcomeNumber· Baseline up to 48 weeks during vaccine treatment

Number of Participants Experiencing Adverse Events by Maximum Grade Within Different Arms

Group	Value (participants)
gp100 + Leuprolide	0
gp100 - No Leuprolide	0
gp100 + MAGE-3 + Leuprolide	1
gp100 + MAGE-3 - No Leuprolide	0

Secondary outcomeNumber· Baseline up to 48 weeks during vaccine treatment

Summary of Adverse Events by Grade/Relationship

Group	Value (occurences)
gp100 + Leuprolide	0
gp100 - No Leuprolide	0
gp100 + MAGE-3 + Leuprolide	1
gp100 + MAGE-3 - No Leuprolide	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
gp100, Leuprolide, MAGE-3HLA-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)	–	3 / 47	47 / 47
gp100 + No LeuprolideHLA-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)	–	3 / 51	51 / 51

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. HLA-A \*0201 positive 2. Patients \>/= 18 years old with histologically documented diagnosis of stage IIb-IV melanomas and are clinically rendered free of disease after surgery 3. Uveal melanoma patients following definitive treatment of radiation therapy and/or enucleation. 4. Karnofsky Performance Scale \>/= 60%. 5. White Blood Count (WBC) \>/= 3000/mm\^3. 6. Platelet count \>/= 90,000mm\^3. 7. Serum creatinine \</= 2.0mg/dl. 8. Serum alanine aminotransferase (ALT) \</= 3 times upper limit of normal(ULN)) 9. Total bilirubin equal or less than 2 times upper limit of normal (ULN)), except for patient with Gilbert's syndrome who must have a total bilirubin less than 3.0mg/dl. 10. Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) 11. Negative pregnancy test by serum or urine b-HCG test for women who have menstruation in the past 12 months and without sterilization surgery. 12. Unless surgically sterile by bilateral tubal-ligation or vasectomy of partner(s), the subject agrees to continue to use a barrier method of contraception throughout the study such as: condom, or diaphragm, or sponge plus spermicide. Abstinence is an acceptable form of birth control. Exclusion Criteria: 1. Prior systemic therapy (including immunomodulate agents), radiation or surgery requiring general anesthesia for melanoma within 28 days of starting study treatment. 2. Autoimmune diseases. 3. Concurrent systemic or inhaled steroid therapy. 4. Any form of active primary or secondary immunodeficiency. 5. History of immunization with gp100 or MAGE-3. 6. Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least for 5 years), or any other cancer from which the patient has been disease-free for 5 years. 7. Received a Luteinizing hormone-releasing hormone (LHRH) agonist within the past 5 years. 8. Use of oral contraceptive, hormone replacement therapy or androgen preparations. 9. Hypersensitivity to gonadotropin-releasing hormone analogues. 10. Active systemic infections requiring intravenous antibiotics. 11. Lactating women or women planning lactation during the study.

PepBank is a research reference. Talk to a doctor before you use any peptide.