Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Vaccines

Poly ICLC

Freund's Adjuvant

Resiquimod

Immunomodulating Agents

Immunologic Factors

Interferons

Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + IFA + PolyICLC vaccines administered in one skin location. Each vaccine will be administered in the same skin site for all 6 vaccines.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

1.5 mL administered half intradermally and half subcutaneously.

Peptide Vaccine (LPV7) + Tetanus peptide

1 mL administered half intradermally and half subcutaneously

PolyICLC

500 mg applied to vaccine site after vaccine administration

2 mL administered half intradermally and half subcutaneously

Craig L Slingluff, Jr., M.D.

The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine and these drugs cause any changes in your immune system.

Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists

Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)

Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists.

Patients are evaluated by safety labs and physical exams to assess for toxicity.

Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.

CD4+ T cell responses to peptides in the vaccine, and their function

University of Virginia

Craig L Slingluff, Jr

Professor, Department of Surgery

All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study

Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

IFA: 2 mL administered half intradermally and half subcutaneously

Arm A (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Arm B (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

Arm C (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

Arm D (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Except that one participant on Part 2 did not have tetanus peptide in the vaccine, and that participants vaccines were all administered at the same vaccine site.

Arm E (Part 1 + 2)

Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously

Arm F (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously

Arm G(Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously.

Except that the last patient, on Part 2 received all 6 vaccines in the same site and did not receive tetanus peptide.

Total

Median Age

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Craig Slingluff, MD; Professor, Department of Surgery; Program Director, UVA Cancer Center

BLOOD/LYMPHATIC - Other

EAR/LABYRINTH - Tinnitus

GASTROINTESTINAL - Constipation

GASTROINTESTINAL - Diarrhea

GASTROINTESTINAL - Mucositis oral

GASTROINTESTINAL - Nausea

GASTROINTESTINAL - Other

GASTROINTESTINAL - Vomiting

GENERAL AND ADMINISTRATION SITE - Chills

GENERAL AND ADMINISTRATION SITE - Fatigue

GENERAL AND ADMINISTRATION SITE - Fever

GENERAL AND ADMINISTRATION SITE - Flu like symptoms

GENERAL AND ADMINISTRATION SITE - Injection site reaction

GENERAL AND ADMINISTRATION SITE - Localized edema

GENERAL AND ADMINISTRATION SITE - Other

GENERAL AND ADMINISTRATION SITE - Pain

IMMUNE SYSTEM - Autoimmune disorder

INJURY/POISONING/PROCEDURAL - Bruising

INVESTIGATIONS - Lymphocyte count decreased

INVESTIGATIONS - Weight loss

INVESTIGATIONS - White blood cell decreased

METABOLISM/NUTRITION - Anorexia

MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia

MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness

MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia

MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity

MUSCULOSKELETAL/CONNECTIVE TISSUE - Other

NERVOUS SYSTEM - Dizziness

NERVOUS SYSTEM - Dysgeusia

NERVOUS SYSTEM - Headache

PSYCHIATRIC - Anxiety

RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis

RESPIRATORY/THORACIC/MEDIASTINAL - Cough

RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea

RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat

SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis

SKIN/SUBCUTANEOUS TISSUE - Pain of skin

SKIN/SUBCUTANEOUS TISSUE - Pruritus

SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular

SKIN/SUBCUTANEOUS TISSUE - Scalp pain

SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation

SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation

SKIN/SUBCUTANEOUS TISSUE - Skin induration

SKIN/SUBCUTANEOUS TISSUE - Skin ulceration

VASCULAR - Flushing

VASCULAR - Hot flashes

VASCULAR - Other

DLTs

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma (except that the vaccines were administered to the same skin site for the one patient from cohort 2)

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously. (except that the tetanus peptide was not included in the vaccine for the one patient on this arm from cohort 2.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Arm E (Part 1 + Part 2)

Number of Participants With Treatment-related Adverse Events Per Study Arm

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Except that one patient, on Part 2, received all 6 vaccines in the same skin site, and did not have tetanus peptide in the vaccine.

Arm E (Part 1)

T Cell Response in Peripheral Blood Over Duration of Study Participation

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Except that one participant on Arm E was on Part 2, where all vaccines were administered at the same vaccine site, and the tetanus peptide was not included in the vaccines.

T Cell Response and Function in Peripheral Blood

Overall Study

Infections

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for twelve weeks.

A second purpose is to evaluate the safety of the drug.

Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults

A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel for the Treatment of Common Warts in Adults

Graceway Pharmaceuticals, LLC

Recurrence

Monatide (IMS 3015)

Adjuvants, Immunologic

Patients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in Montanide ISA 51 VG SC on day 1.

Patients receive MART-1 antigen emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1.

Patients receive MART-1 antigen and Gag:267-274 peptide vaccine peptide vaccine emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1.

Montanide ISA 51 VG

MART-1 antigen

laboratory biomarker analysis

Gag:267-274 peptide vaccine

resiquimod

Svetomir Markovic, M.D., Ph.D.

This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately

PRIMARY OBJECTIVES:

I. Evaluate the immune response of each immunization regimen and determine an optimal regimen in terms of immune response to recommend for phase II testing.

SECONDARY OBJECTIVES:

I. Evaluate the adverse events profile of each immunization regimen. II. Evaluate disease-free survival.

TERTIARY OBJECTIVES:

I. Describe the immunological efficacy of the vaccine preparations with Gag267-274 (Gag:267-274 peptide vaccine) and resiquimod, as measured by the frequency and interferon (IFN)gamma production of peptide-specific cytotoxic T lymphocytes (CTL).

II. Examine immune responses to the tumor antigen analog MART-1a (MART-1 antigen) versus the xenoantigen Gag267-274.

OUTLINE: Patients are assigned to 1 of 3 treatment groups.

ARM I: Patients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in Montanide ISA 51 VG subcutaneously (SC) on day 1.

ARM II: Patients receive MART-1 antigen emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1.

ARM III: Patients receive MART-1 antigen and Gag:267-274 peptide vaccine emulsified in Montanide ISA 51 VG SC followed by resiquimod applied topically on day 1.

In all arms, treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, 9, 12 and 24 months.

Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery

Peptide Vaccine With Resiquimod as an Immune Modulator for Patients With Resected Melanoma: A Pilot Study

The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true immune response rate will be calculated.

Estimated using the method of Kaplan-Meier.

The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

National Cancer Institute (NCI)

Mayo Clinic

The primary purpose of this study is to evaluate the effectiveness in adults of 2 different strengths of resiquimod gel applied to common wart(s) five times a week for up to 12 weeks.

A second purpose is to evaluate the safety of the drug.

Study With a Topical Gel to Treat Common Warts in Adults

A Two-Stage, Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 5 Times Per Week for up to 12 Weeks for the Treatment of Common Warts in Adults

The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks.

A second purpose is to evaluate the safety of the drug.

Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects

A Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Pediatric Subjects

1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately. Injections given intradermally and subcutaneously at 2 separate sites in separate extremities. Half of each dose given one way, and half given the other way. Vaccines given on the same day. Participant receives a total of 4 injections each week.

After 8 weeks, if participant has melanoma lesions, R848 applied to half of the lesions on body for 16 weeks.

1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks. Injections given intradermally and subcutaneously at 2 separate sites in separate extremities. Half of each dose given one way, and half given the other way. Vaccines given on the same day. Participant receives a total of 4 injections each week.

After 8 weeks, if participant has melanoma lesions, R848 applied to half of the lesions on body for 16 weeks.

1 ml of gp100 peptide vaccine: 0.5 ml administered intradermally and the other 0.5 ml subcutaneously in the same extremity weekly (every 7 days +/- 2 days) for 8 weeks.

gp100

Applied to the gp100 vaccine injection site immediately following the injection, allowed to air dry for 30 minutes then covered with gauze dressing.

R848 gel

1 ml of MAGE-3 peptide vaccine: 0.5 ml administered intradermally and the other 0.5 ml subcutaneously in the same extremity weekly (every 7 days +/- 2 days) for 8 weeks.

MAGE-3

Michael A. Davies, PHD

The goal of this clinical research study is to learn if the vaccines, gp100(g209-2M), and MAGE-3, when given in combination with resiquimod (R848), can help to stimulate the immune system against melanoma.

The Study Drug/Vaccines:

Resiquimod (R848) is designed to increase the production of antigen-specific T-cells, to activate immune cells, and to increase T-cells going into the tumor, which may cause the tumor cells to die.

gp100(g209-2M) and MAGE-3 are vaccines designed to stimulate immune cells, also called T-cells, which may help the immune system to recognize and kill melanoma cells.

Study Groups:

If you are found to be eligible to take part in this study, and you have metastatic melanoma, you will be assigned to Group 3. If you have had the melanoma removed and want to be treated to try to keep it from coming back, you will be randomly assigned (as in the flip of a coin) to Group 1 or 2.

* If you are in Group 1, you will receive the vaccines gp100(g209-2M) and MAGE-3 and R848 for 8 weeks. After 8 weeks, if you have melanoma lesions, you will apply R848 to half of the lesions on your body for 16 weeks.
* If you are in Group 2, you will receive only the vaccines (gp100(g209-2M) and MAGE-3) only for 8 weeks. After 8 weeks, if you have melanoma lesions, you will apply R848 to half of the lesions on your body for 16 weeks.
* If you are in Group 3, you will receive the vaccines gp100(g209-2M) and MAGE-3 and R848 for 8 weeks. After 8 weeks, if you have melanoma lesions, you will apply R848 to half of the lesions on your body for 16 weeks.

After 8 weeks, if you no longer have melanoma lesions, you will have completed the study treatment.

Study Drug/Vaccine Administration:

Once a week for 8 weeks, you will receive the vaccines, gp100(g209-2M) and MAGE-3, intradermally (through a needle into your skin) and subcutaneously (through a needle under your skin) at 2 separate sites in separate extremities. Half of each dose will be given one way, and half given the other way. These vaccines will also be given on the same day. You will receive a total of 4 injections each week.

If you are in Group 1, every time you have the vaccine injection, R848 will be applied as a gel over the gp100(g209-2M) injection site. The R848 gel will be allowed to air dry for 30 minutes and then covered with a gauze dressing which remain on overnight.

After 8 weeks, for participants with melanoma lesions, 2 times a week for 16 weeks, you will apply the R848 gel to half of the lesions on your body. You will be given written instructions and a "hands-on" demonstration on how to apply the gel. You will also be given a worksheet to help you with applying the gel.

Study Visits:

One day after your first dose of vaccine (Day 2), you will have a punch biopsy of the vaccine injection site to check your immune system. A punch biopsy is when a hollow instrument that is used to remove a small coin-shaped sample of tissue.

At Week 2, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* Your performance status will be recorded.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* Blood (about 4 tablespoons) will be drawn to study your immune response to the vaccine combinations.
* You will have a punch biopsy of the injection site to check your immune system the day after the vaccine is given.

Every 4 weeks, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* Your performance status will be recorded.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* Blood (about 4 tablespoons) will be drawn to study your immune response to the vaccine combinations.

Every 8 weeks, for participants with metastatic disease, the following tests and procedures will be performed:

* You will have CT or PET/CT scans of the chest, abdomen, and pelvis to check the status of the disease.
* The tumors will be measured and photographed. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are tumors on your face.
* If the doctor thinks it is necessary, the tumors will be measured by CT scan.
* If the doctor thinks it is needed, you will have an MRI/CT of the brain to check the status of the disease.

The day after you first start the gel (Week 8), you will have 2 punch tumor biopsies to check your immune system. One biopsy will be of a lesion with the R848 and one without, if it is available. For participants without disease, the study will be completed and your follow-up will be decided by your doctor.

At Week 0 (before vaccine is started), after treatment at Week 8 (+/- 1 week)., and Week 16 (+/- 1 week), white blood cells will be collected by leukapheresis to test for antibodies. If you have the leukapheresis, blood (about 2 teaspoons) will be drawn as well. If you do not have leukapheresis, blood (about 4 tablespoons) will be drawn instead.

The leukapheresis procedure is research-related and would not be performed as standard of care if you were not on study. Blood for the leukapheresis will be taken through a needle in a vein in one of your arms. A solution will be added to keep your blood from clotting while it goes through the machine that collects and removes white blood cells from your blood. The remaining blood is returned to you through a needle in a vein of your other arm. This is may take up to 3-4 hours. Although several pints of blood will go through the machine, only about 1/2 a pint (1 cup) will be in the machine at any time. If you cannot have a needle in your vein, this blood will be removed thorough a central venous catheter (CVC). A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. You will be given another informed consent document to sign, which describes the risks of the CVC and the care involved.

Length of Study:

You will continue to receive treatment for up to 4 6 months, as long as you may benefit from the study and are responding to the gel. You will be taken off study if the disease gets worse or you experience any intolerable side effects. If you are in the group without disease, you will not receive the study treatment.

Follow-Up:

All three groups will be called 1 time a month for 12 months after coming off the study drugs to check on the status of the disease.

This is an investigational study. The study drugs/vaccines gp100(g209-2M), MAGE-3, and R848 are not FDA approved or commercially available. At this time, they are only being used in research.

Up to 71 participants will take part in this study. All will be enrolled at MD Anderson.

Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist

Activation of pDCs at the Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist

T-cell response to gp100(g209-2M) +/- MAGE3 measured at 8 weeks using a tetramer/multimer assay measured by flow cytometry. Based on the number of gp100(g209-2M) +/- MAGE3 T-cells measured, categorized as either immune responders or immune non-responders. T-cell response to the gp100(g209-2M) + /- MAGE3 peptide in each participant defined as ≥0.1% gp100(g209-2M) tetramer+ cells in the CD8+ T-cell population or ≥0.1% MAGE3 multimer cells in the CD4+ T-cell population.

Differences determined in each of these parameters between the pretreatment and post-treatment samples for each of the biopsied lesions for each participant.

M.D. Anderson Cancer Center

1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks with R848 Gel applied to gp100 injection site immediately.

Group 1: GP100 and MAGE-3 + R848

1 ml of gp100 peptide vaccine and 1 ml of MAGE-3 peptide vaccine daily for 8 weeks.

Group 2: GP100 and MAGE-3

Group 3-Metastatic Melanoma: GP100 + MAGE-3 + R848

Age, Categorical

Michael Davis, PHD., Chair, Melanoma Medical Oncology

The original PI is no longer in the institution. Due to the absence of the original PI is no longer in the institution and the data is unavailable. The analysis for the primary outcome measure the comparison of immune responses of vaccine+R848 to vaccine alone is not available. All efforts were made to retrieve data.

Spots Global Cancer Trial Database for resiquimod

Every month we try and update this database with for resiquimod cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists	NCT02126579	Melanoma Metastatic Mela... Mucosal Melanom...	Peptide Vaccine... PolyICLC Resiquimod IFA	18 Years -	University of Virginia
Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults	NCT00114920	Warts	Resiquimod	18 Years -	Graceway Pharmaceuticals, LLC
Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery	NCT01748747	Recurrent Melan... Stage IIA Melan... Stage IIB Melan... Stage IIC Melan... Stage IIIA Mela... Stage IIIB Mela... Stage IIIC Mela... Stage IV Melano...	Montanide ISA 5... MART-1 antigen laboratory biom... Gag:267-274 pep... resiquimod	18 Years -	Mayo Clinic
Study With a Topical Gel to Treat Common Warts in Adults	NCT00117871	Warts	Resiquimod	18 Years -	Graceway Pharmaceuticals, LLC
Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects	NCT00116675	Warts	Resiquimod	3 Years - 11 Years	Graceway Pharmaceuticals, LLC
Tumor and Vaccine Site With a Toll Like Receptor (TLR) Agonist	NCT00960752	Melanoma	gp100 R848 gel MAGE-3	18 Years -	M.D. Anderson Cancer Center
Vaccine Therapy and Resiquimod in Treating Patients With Stage II, Stage III, or Stage IV Melanoma That Has Been Completely Removed by Surgery	NCT00470379	Melanoma (Skin)	resiquimod	18 Years -	Mayo Clinic
Study With a Topical Gel to Treat Common Warts in Adults	NCT00117871	Warts	Resiquimod	18 Years -	Graceway Pharmaceuticals, LLC
Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults	NCT00114920	Warts	Resiquimod	18 Years -	Graceway Pharmaceuticals, LLC
Study With a Topical Gel to Treat Common Warts in Adults	NCT00117923	Warts	Resiquimod	18 Years -	Graceway Pharmaceuticals, LLC

Spots Global Cancer Trial Database for resiquimod

Every month we try and update this database with for resiquimod cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for resiquimod cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.