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

Vaccines

Resiquimod

Immunomodulating Agents

Immunologic Factors

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

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

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.

Comparison of Immune Responses of Vaccine+R848 to Vaccine Alone

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 not available. The analysis for the secondary outcome measure the composite of Immune Cell Infiltration for pDCs, mDCs, and NK cells in Tumor Biopsy Samples data is unavailable .All efforts were made to retrieve data.

Composite of Immune Cell Infiltration for pDCs, mDCs, and NK Cells in Tumor Biopsy Samples

Overall Study

Symptoms and General Pathology

Nervous System Diseases

Pain, Postoperative

Pain

Abdominal Pain

Postoperative Complications

Neurologic Manifestations

Signs and Symptoms, Digestive

Central Nervous System Depressants

Pharmaceutical Solutions

Herbal and Botanical

Ropivacaine

Anesthetics

Anesthetics, Local

Cola

Ultrasound-guided TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and laparoscopic assisted injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Laparoscopic assisted TAP with 20 ml ropivacaine 2 mg/ml solution bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Laparoscopic assisted injection of 20 ml saline (placebo) bilaterally and ultrasound-guided injection of 20 ml saline (placebo) bilaterally at the beginning of surgery

Active drug

Placebo

Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml

Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block

Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml

Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block

Lateral ultrasound-guided transverse abdominal plane block with saline solution

Injection of placebo - Ultrasound-guided transverse abdominal plane block

Laparoscopic assisted subcostal transverse abdominal plane block with saline solution

Injection of placebo - Laparoscopic assisted transverse abdominal plane block

Claus A Bertelsen, PhD

Christopher B Salmonsen, MD

Victor J Verwall, PhD

Anders H Madsen, PhD

Uffe S Løwe, PhD

The purpose of the trial is to identify the "most simple non-inferior of three different methods", placebo, laparoscopic assisted transverse abdominal plane block (L-TAP) and ultrasound guided TAP block (US-TAP), using postoperative opioid consumption as a measure of efficacy in patients undergoing elective minimally invasive colon surgery in an ERAS setting. Postoperative pain scores and length of stay (LOS) will also be measured. The simplicity of the three methods is ranked as: 1) placebo, 2) L-TAP and 3) US-TAP.

Introducing laparoscopy in colorectal surgery and optimizing the postoperative care using the standardized protocols of enhanced recovery after surgery (ERAS) have significantly improved patient outcomes and LOS. Better pain management has the potential to further improve these outcomes. Since the introduction of ultrasound-guided abdominal wall blocks, much research has been done in that field, but no consensus has been reached concerning the optimal block technique; where to and when to inject the block, or which drug to use. Newly published randomized controlled trials show interesting results regarding the L-TAP which has several advantages to the US-TAP, including the ease of performance, less dependency on specialized skills or equipment and avoidance of intraperitoneal infiltration. but these results need to be solidified with multicentre trials. Besides optimizing postoperative pain management, better block techniques could potentially decrease LOS in patients after minimally invasive colorectal surgery.

Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery

Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block in Minimally Invasive Colon Surgery: A Randomized Controlled Multicentre Clinical Trial

After de-identification, individual participant data will be made available to investigators who provide a methodologically sound proposal for meta-analyses. Proposals should be directed to Claus A Bertelsen (cabertelsen@gmail.com). A Data Processing Agreement according to the EU General Data Protection Regulation has to be signed before data sharing.

11-point Numeric Rating Scale. 0-10 (higher score - worse outcome).

11-point Numeric Rating Scale. 0-10 (higher score means worse outcome)

Days - Measured from the end of anesthesia.

4-point Numeric Rating Scale. 0-3 (higher score means worse outcome).

From the end of anesthesia to discharge to ward. Measured in hours and minutes.

4-point Verbal Rating Scale. 1-4 (higher score means worse outcome).

The Quality of Recovery 15 is a 15-item questionnaire that measures the patient's quality of recovery. Each item is answered on an 11-point Numerical Rating Scale. The score ranges from 0 to 150 with a higher score indicating a better quality of recovery. It measures in the domains of pain, physical comfort, physical independence, psychological support, and emotional state.

According to the Clavien-Dindo classification of surgical complications.

Epidural or TAP-block administered post surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
Optimal Peripheral Nerve Block After Minimally Invasive Colon Surgery	NCT04311099	Pain, Postopera... Pain, Abdominal Analgesia Surgery Colon Cancer Injection Site	Active drug Placebo Injection of Ro... Injection of Ro... Injection of pl... Injection of pl...	18 Years -	Nordsjaellands Hospital

Spots Global Cancer Trial Database for injection site