Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Inflammatory Breast Neoplasms

Breast Diseases

Skin Diseases

Inflammatory Breast Cancer

One form of breast cancer, known as inflammatory breast cancer (IBC), is characterized by diffuse erythema (redness) and edema (peau d'orange) of the breast. This type of cancer is aggressive and poorly understood. It is rare in the United States (about 4 percent of cases), but more common in Egypt and Tunisia (up to 23 percent of cases). Conducting a case-control study of IBC is complicated by several factors, including the lack of standardized criteria for IBC. In addition, collecting pre-chemotherapy tissue and blood samples from IBC patients is difficult because treatment begins immediately after diagnosis.

In this pilot study, the National Cancer Institute will collaborate with two major cancer centers and two hospitals (in Egypt and Tunisia) to determine the feasibility of a case-control study of IBC. The study will assess the number and characteristics of IBC cases, the feasibility of identifying cases at diagnosis, and the availability of control subjects; will collect frozen pre-treatment tumor tissue from five IBC cases to determine whether RNA isolation is possible; will obtain digital photographs of the breasts of IBC cases; and will demonstrate collaboration between the institutions and personnel involved in the study. The study will last for approximately one year.

Participating hospitals will identify IBC cases. Consenting patients will undergo a breast examination in which the examining surgeon will complete an Initial Examination Form (IEF). Digital photographs of the breasts (but not face) will be taken and linked to the study ID number. Tissue examination results will be entered into the IEF. For five selected cases, additional pre-treatment tumor tissue will be collected and frozen.

This pilot study will assess the availability of controls for a case-control study by investigating the number and type of admissions to the Ear, Nose, and Throat and Ophthalmology Departments at participating hospitals during 2000-2003, using computerized records.

Breast cancer characterized by diffuse erythema and edema, or peau d'orange, of the breast (inflammatory breast cancer (IBC)) is rare, particularly aggressive, and poorly understood. The extent of redness and edema or peau d'orange, of the breast required for a diagnosis of IBC has not been standardized. According to the most recent American Joint Committee on Cancer (AJCC) definition of inflammatory breast cancer, the signs of redness and edema or peau d'orange, should cover the majority of the breast, and should have arisen quickly. Breast cancers with redness and edema or peau d'orange, account for approximately 4 percent of breast cancers in the United States, but up to 23 percent of breast cancers in Egypt and Tunisia.

The proposed pilot study will determine the feasibility of conducting a case-control study of inflammatory breast cancer in collaboration with the National Cancer Institute-Cairo, Egypt, and the Institut Salah Azaiz, Tunis, Tunisia, the major cancer centers in Egypt and Tunisia, and Cairo University Hospital and Charles Nicolle Hospital, affiliated general hospitals from which controls will be selected. Currently, neither case study hospital collects data on the number of inflammatory breast cancer cases meeting the AJCC definition which will be used for the proposed case-control study. In addition, the geographic distribution of IBC cases at the two study hospitals (knowledge of which is necessary for the selection of appropriate controls) is unknown.

The goals of the pilot study are to assess the feasibility of the following critical components of the case-control study: 1) identifying a sufficient number of IBC cases at the time of diagnosis in the two study hospitals; 2) selecting appropriate hospital-based control subjects; 3) collecting frozen pre-treatment tumor tissue; 4) obtaining digital photographs of the breasts of IBC cases; and 5) communicating and working collaboratively with the study hospitals and personnel in Egypt and Tunisia. To accomplish these objectives, IBC cases meeting the AJCC definition as well as cases meeting other definitions of IBC will be identified over a one-year period at each of the two study hospitals. Computerized records at the control hospital for the years 2000-2003 will be used to enumerate the number of female patients with non-chronic diseases (and their age and geographic distribution) in the Departments of Ophthalmology and Ear, Nose and Throat (ENT). Pre-treatment frozen tumor tissue and digital photographs of the breast will be collected from five IBC cases at each study site.

Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia

National Cancer Institute (NCI)

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

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

LL37 administered intratumorally in cutaneous or subcutaneous tumors at least 1 cm in diameter. Patients will receive weekly intratumoral injections of LL37 for up to 8 weeks. The injections will be given every 7 days (+/- 48 hours). Starting dose 250 µg/tumor.

Starting dose 250 µg/tumor. The injections will be given every 7 days for up to 8 weeks.

LL37

Tumors measured and photographed one week before receiving LL37, and again at 4 weeks after LL37. Then photographs of the LL37 injected sites taken at 8 weeks.

Photographs

Rodabe N. Amaria, MD

The goal of this clinical research study is to find the appropriate dose of LL37 that can be given to patients with melanoma. Researchers also want to learn if LL37 can stimulate the immune system to help control the disease.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of LL37 based on when you join this study. Up to 4 dose levels of LL37 will be tested. Up to 2 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of LL37 is found.

Study Drug Administration:

One (1) time a week for 8 weeks, LL37 will be injected into 2-4 tumors. The injections will be done in the clinic.

Study Visits:

Within 1 week before your first study drug injection:

* You will have a physical exam.
* You will have a punch biopsy of a tumor. To collect a punch biopsy, the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* 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.

On Day 1:

* You will have a physical exam.
* Blood (about 1 teaspoon) will be drawn for routine tests.

On Day 2, you will have a punch biopsy of one of the injected tumors.

At Weeks 1, 2, 3, 4, 5, 6, 7, and 8:

* You will have a physical exam.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* At Weeks 1, 3, and 5 and 7, blood (about 4 tablespoons) will be drawn to study your immune response to LL37.

At Week 4, you will have a punch biopsy of one of the injected tumors and one of the tumors that you did not have an injection in. Photos of the tumors will be taken to show if the disease has responded to the study drug.

At Week 8:

* Photos of the LL37 injected sites will be taken to show if the disease has responded to the study drug.
* You will have CT scans to check the status of the disease.

Length of Treatment:

You will receive up to 8 weeks of study treatment. You will be taken off study if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Off-Study Visit:

If you have to stop the study treatment earlier than planned because the disease got worse or you had intolerable side effects:

* You will have a physical exam.
* The tumors will be photographed and measured.
* Blood (about 4 teaspoons) will be drawn for routine tests and to study your immune response to LL37.
* You will have CT scans to check the status of the disease.
* You will have a punch biopsy of one of the injected tumors.

These off-study procedures will be completed within 14 days after your last dose of study treatment. You will be contacted by phone or clinic visit at 30 days (+/- 7 days) after your last dose to follow up on any drug-related toxicities which were present at the end of study.

Follow-Up:

Within 2 weeks after your last study drug dose and every 8-12 weeks after that, you will have scans to check the status of the disease. Your doctor will decide what type of scans you will have.

After your last study drug dose, at your routine clinic visits every 3 months for 1 year, the study staff will ask you about the status of disease, if possible. If you do not plan to continue to receive medical care at MD Anderson, the study staff will contact you by phone, email, or letter to ask about the status of disease. The calls should last about 5 minutes.

This is an investigational study. LL37 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.

Up to 36 participants will be treated in this study. All will take part at MD Anderson.

Intratumoral Injections of LL37 for Melanoma

Induction of Antitumor Response in Melanoma Patients Using the Antimicrobial Peptide LL37

Dose Limiting Toxicity defined as: a. Any grade 3 or 4 non-hematologic toxicity regardless of duration, except: Grade 3 skin reactions at injection sites - Grade 3 fever b. Grade 4 thrombocytopenia c. Grade 4 neutropenia lasting \>2 weeks or associated with infection.

Response defined as experiencing either an immune-related complete or partial response (irCR or irPR), and the association between response and disease characteristics and T-cell responses will be assessed using logistic regression.

M.D. Anderson Cancer Center

This cohort received starting dose of 250 ug/tumor injection once a week

Cohort 1

This cohort received 500 ug/tumor injection once a week

Cohort 2

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Rodabe Amaria,MD, Associate Professor, Melanoma Medical Oncology

Number of Participants With Optimal Biological Dose (OBD) of LL37 Based Upon Toxicity

Number of Participants With Antitumor Immune Response of Intra-Tumoral Injection of LL37

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia	NCT00344071	Inflammatory Br...		-	National Institutes of Health Clinical Center (CC)
Intratumoral Injections of LL37 for Melanoma	NCT02225366	Melanoma	LL37 Photographs	18 Years -	M.D. Anderson Cancer Center

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Every month we try and update this database with for photographs cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for photographs

Every month we try and update this database with for photographs 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 photographs 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.