Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Infections

Eye Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Basal Cell

Carcinoma, Merkel Cell

Eyelid Neoplasms

Adenocarcinoma, Sebaceous

Eccrine Porocarcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplasms, Basal Cell

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Neoplasms, Adnexal and Skin Appendage

Merkel Cell Carcinoma

Conjunctival Melanoma

Neuroendocrine Tumor

Neuroepithelioma

patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with squamous cell Carcinoma of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

* Injection of 99mTc-labeled nanocolloids
* Preoperative lymphoscintigraphy
* Intraoperative gamma probe search of the sentinel lymph node
* Sentinel lymph node biopsy
* Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
* If the SLN is histologically positive, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.

Sentinel Lymph Node Biopsy

Gustavo Savino, MD

The study involves enrollment of patients with sebaceous carcinoma, Merkel's carcinoma, Porocarcinoma, Melanoma, and squamous cell Ca of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at the Fondazione Policlinico Universitario A. Gemelli, IRCCS. The study will last 9 years: 1 year will be devoted to the first phase of the study. Patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. A preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate OS and PFS at the 3 time-points indicated are planned.

Patients will undergo:

* Evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography
* Staging according to TNM AJCC 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (MRI with mdc orbits, massif and neck + Tc/Pet total body)
* Injection of 99mTc-labeled nanocolloids
* Preoperative lymphoscintigraphy
* Intraoperative search by gamma probe of the sentinel lymph node
* Sentinel lymph node biopsy
* Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.
* In case of SLN histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.
* Clinical-instrumental follow-up to be performed in current clinical practice (Clinical examination, cranial orbit and neck MRI, total body CT scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the Tumor Board.

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study

Positive predictive value (PPV) and negative predictive value (NPV), in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.

Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.

Changes in clinical parameter (tumor diameters) of patients at follow-up (3, 6, 12, 24, 36, 48, 60 months)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Professor

Digestive System Diseases

Gastrointestinal Stromal Tumors

Fibromatosis, Aggressive

Carcinoma, Adenoid Cystic

Chordoma

Dermatofibrosarcoma

Ocular Melanoma

Desmoid Tumor

Adenoid Cystic Carcinoma

Dermatofibrosarcoma Protuberans

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Amino Acids

Cyclophosphamide

Imatinib Mesylate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

CYCLE 1 (42 days):

* Day 1 to 14 Imatinib mesylate : 400 mg/day, per os
* Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os

NEXT CYCLE (28 days):

Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 400 mg/day, per os

Imatinib mesylate, Cyclophosphamide (Dosing level 1 )

CYCLE 1 (42 days):

* Day 1 to 14 Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os
* Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening) per os

NEXT CYCLE (28 days):

Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 600 mg/day,(300 mg in the morning and 300 mg in the evening)per os

Imatinib mesylate, Cyclophosphamide (Dosing level 2)

CYCLE 1 (42 days):

* Day 1 to 14 Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os
* Day 15 to 42 Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening) per os

NEXT CYCLE (28 days):

Cyclophosphamide : 50 mg x 2/day, per os Imatinib mesylate : 800 mg/day,(400 mg in the morning and 400 mg in the evening)per os

Imatinib mesylate, Cyclophosphamide (Dosing level 3)

ONLY FOR CYCLE 1, at day 15 and day 28 :

11 sampling for dosing level 1 (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12 , +24 hours, cyclophosphamide + 12 hours) 10 sampling for the next dosing level (pre-dose, imatinib mesylate + 30 min, +1, +2, +3, +4, +6, +10, +12,cyclophosphamide + 12 hours)

Blood sampling

Antoine ADENIS, MD, PhD

The purpose of this study is to determine the maximum tolerated dose of imatinib mesylate, given in association with a fixed dose of cyclophosphamide (50 mg bid).

Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate

Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate in Patient With Rare Tumor (Phase I Study)

Centre Oscar Lambret

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Intraoperative lymphatic mapping, then biopsy/removal of the conjunctiva/eyelid tumor.

Sentinel Lymph Node Mapping and Biopsy

Bita Esmaeli, MD

The goal of this clinical research study is to find the sentinel lymph node (SLN) (s) and biopsy it (them) to see if the patient has small or low volume metastatic disease that would otherwise have been missed.

You have had your conjunctival or eyelid tumor surgically removed or it is scheduled to have it removed. You will have lymphatic mapping before the tumor is removed. Lymphatic mapping is when a small volume of Tc99m-Sulfur colloid is injected by an ophthalmologist after which some radiologic images are taken.

If you are able to become pregnant, blood (about 2 teaspoons) will be drawn for a pregnancy test, within 7 days before the biopsy. To take part in this study, you must not be pregnant.

You will then go to the operating room and have intraoperative SLN mapping and biopsy. If the SLN is positive on permanent section, you will go on to have complete lymph node dissection, which involves removal of all the lymph nodes around the positive SLN. Then the disease will be restaged and you may require further treatment after consultation with their oncologist.

Your medical record will be reviewed, and information from your medical record will be recorded and reviewed to help researchers better identify those patients who have microscopic lymph node disease. The information collected from your medical records will include information about your sex, age, what type of cancer that you have, as well as the size of the cancer and its location.

Researchers hope to identify those patients who have microscopic lymph node disease before it becomes clinically obvious. With this technique, researchers could potentially identify occult metastatic disease which would otherwise go unnoticed until it was too advanced. Patients in this study will have to see the ophthalmologist every three months and have the usual metastatic workup, which is routine for conjunctival/eyelid melanoma.

Length of Study:

Your active participation on this study will be over once the biopsy is over. You will continue to be observed on study for 5 years after the biopsy.

Long-Term Follow-Up:

Every 3 months for the first year after the biopsy, and every 6 months after that until 5 years after the biopsy, you will have an eye exam to check the status of the disease.

Every 6 months for the first year after the biopsy, blood (less than 1 teaspoon) will be drawn for liver function tests. You will also have a chest x-ray. You will then have these tests 1 time each year for 5 years after the biopsy.

You will have a head and neck CT or MRI every 6 months for the first year after the biopsy to make sure the disease has not come back. The head and neck CT or MRI will be repeated 1 time each year for 5 years after the biopsy.

This is an investigational study. A total of 38 patients will take part in this study. All will be enrolled at MD Anderson Cancer Center.

Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma

Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma

The frequency of lymphatic drainage basins for bulbar versus palpebral conjunctiva and for nasal and the temporal quadrants estimated with 95% confidence intervals. The rate of identification of SLN evaluated with a confidence interval. The probability of positive SLN in primary conjunctival and eyelid melanoma estimated.

M.D. Anderson Cancer Center

Gland and Hormone Related Diseases

Syndrome

Recurrence

Esophageal Neoplasms

Pheochromocytoma

Cholangiocarcinoma

Pancreatic Neoplasms

Thyroid Diseases

Stomach Neoplasms

Neoplasm Metastasis

Liver Neoplasms

Carcinoid Tumor

Carcinoma, Medullary

Carcinoma, Islet Cell

Insulinoma

Glucagonoma

Somatostatinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Esophageal Cancer

Pancreatic Cancer

Bile Duct Cancer

Stomach Cancer

Primary Liver Cancer

Gallbladder Cancer

Intraocular Melanoma

Small Intestinal Adenocarcinoma

Thyroid Cancer, Medullary

Small Intestine Cancer

WDHA Syndrome

Hematinics

Gastrointestinal Agents

Herbal and Botanical

Melphalan

Liver Extracts

Pancrelipase

Pancreatin

Pancreatic Polypeptide

Cola

isolated perfusion

melphalan

Marybeth Hughes, MD

RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.

OBJECTIVES:

Primary

* Determine the response rate and duration of response in patients with unresectable primary or metastatic liver cancer treated with intrahepatic arterial infusion of melphalan with venous filtration via peripheral hepatic perfusion.

Secondary

* Determine the patterns of recurrence in patients treated with this regimen.
* Determine progression-free and overall survival of patients treated with this regimen.
* Evaluate the safety and tolerability of this regimen in these patients.
* Assess the filter characteristics including melphalan pharmacokinetics and filtration of cytokines and clotting factors during and after treatment.

OUTLINE: Patients are stratified according to primary tumor histology (neuroendocrine tumor vs primary hepatic malignancy vs adenocarcinoma of gastrointestinal or other origin).

Patients undergo peripheral isolated hepatic perfusion in which a catheter is placed via the groin into the hepatic artery and another into the hepatic vein. Patients then receive melphalan as an intrahepatic arterial infusion over 15-30 minutes. Treatment repeats approximately every 3-8 weeks for up to 6 total infusions in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 4 months for 1 year, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study within 4-5 years.

Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer

A Phase II Study Of Hepatic Arterial Infusion Of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion (PHP) For Unresectable Primary And Metastatic Cancers Of The Liver

National Cancer Institute (NCI)

Delcath Systems Inc.

Melanoma, Cutaneous Malignant

Acral Lentiginous Melanoma

Analgesics

Fludarabine

Fludarabine phosphate

Interleukin-2

Mesna

Analgesics, Non-Narcotic

TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product: participants tumor tissue is surgically removed and immune T-cells are taken out of the tumor and multiplied, or grown, in the laboratory. TIL product infused intravenously over 20 to 30 minutes within 2 to 4 days after the last dose of fludarabine

Participants will also receive:

* Cyclophosphamide dose 60 mg/kg/day for 2 days administered IV in 250 mL dextrose 5% in water infused simultaneously with Mesna 15 mg/kg/day delivered over 1 hour per day for 2 days. Fludarabine 25 mg/m2/day is delivered by intravenous piggyback daily over 15-30 minutes for 5 days.
* Interleukin-2 (IL-2)- will be given to participants through IV after they receive the infusion of the TIL. IL-2 is administered at a dose of 600,000 IU/kg (based on actual body weight) IV every 8-12 hours beginning within 24 hours of TIL infusion for a maximum of 6 doses.

TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product that involves the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell.

TBio-4101

Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL over approximately 1 hour per day for 2 days.

Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 15 to 30 minutes for 5 days, prior to T-Cell infusion

Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously every 8 to 12 hours beginning within 24 hours after T-cell infusion.

Yvonne Nguyen

Amod Sarnaik, MD

Veron Sondak, MD

The purpose of this first in human study is to evaluate the feasibility, safety, and efficacy of administering TBio-4101 (tumor infiltrating lymphocytes \[TIL\]) after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 (IL-2) in participants with unresectable or metastatic melanoma.

Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma

A Proof of Concept Study of TBio-4101 (an Autologous Selected and Expanded Tumor Infiltrating Lymphocyte [TIL] Therapy) Using Short-Term Cultured, Selected Autologous TIL Following a Lymphodepleting Chemotherapy Regimen and Followed by IL-2 for Patients With Relapsed or Refractory Melanoma (Phase 1)

Percentage of participants who undergo tumor resection that successfully receive TBio-4101

ORR will be calculated using irRECIST and RECIST v1.1

OS is defined as the time from enrollment to death

PFS is defined as the time from study enrollment until disease progression or death.

DRR is defined as a continuous response, beginning within 12 months of treatment and lasting \> 6 months

Turnstone Biologics, Corp.

H. Lee Moffitt Cancer Center and Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers	NCT05797415	Ocular Sebaceou... Ocular Basal Ce... Ocular Surface ... Merkel Cell Car... Porocarcinoma Conjunctival Me...	Sentinel Lymph ...	18 Years - 95 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers	NCT05797415	Ocular Sebaceou... Ocular Basal Ce... Ocular Surface ... Merkel Cell Car... Porocarcinoma Conjunctival Me...	Sentinel Lymph ...	18 Years - 95 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Imatinib Mesylate And Cyclophosphamide In Metronomic Administration: Dose Escalation Study Of Imatinib Mesylate	NCT01046487	Cancer	Imatinib mesyla... Imatinib mesyla... Imatinib mesyla... Blood sampling	18 Years -	Centre Oscar Lambret
Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma	NCT00386906	Eye Disease Melanoma	Sentinel Lymph ...	18 Years -	M.D. Anderson Cancer Center
Sentinel Lymph Node (SLN) Biopsy for Conjunctival/Eyelid Melanoma	NCT00386906	Eye Disease Melanoma	Sentinel Lymph ...	18 Years -	M.D. Anderson Cancer Center
Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer	NCT00096083	Cancer	isolated perfus... melphalan	16 Years -	Delcath Systems Inc.
Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma	NCT05628883	Metastatic Mela... Unresectable Me... Acral Melanoma Mucosal Melanom... Cutaneous Melan... Ocular Melanoma Uveal Melanoma Iris Melanoma Conjunctival Me... Non-Cutaneous M...	TBio-4101 Cyclophosphamid... Fludarabine Interleukin-2	18 Years - 75 Years	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for conjunctival melanoma