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

Intraocular Melanoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Xenogeneic Tyrosinase DNA Vaccine

TriGrid Delivery System for Intramuscular Electroporation

Jedd D. Wolchok, MD, PhD

The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. In this study, the vaccine will be administered intramuscularly using a device that applies brief electrical fields to the tissue at the site of injection (a technique known as electroporation). It is expected that this device will improve the delivery of the vaccine. This study is being performed to determine if this procedure can be administered safely and if it is capable of inducing immune responses to the vaccine.

This study is designed to evaluate administration of a xenogeneic DNA vaccine encoding the melanosomal antigen tyrosinase by in vivo electroporation in patients with malignant melanoma. The objectives of the study are to characterize the safety and immunogenicity of a DNA vaccine encoding the murine tyrosinase gene delivered administered intramuscularly using the electroporation based TriGrid Delivery System (Ichor Medical Systems). We will assess the nature, frequency, and severity of any toxicity associated with vaccination at escalating pINGmuTyr doses and then expand enrollment at then expand enrollment at the Maximum Tolerated Dose to assess immunologic responses to the tyrosinase antigen.

The hypotheses being tested are that the procedure is feasible and safe and that it induces immune responses specific for tyrosinase in patients with stage IIB-IV malignant melanoma.

Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation

A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma

Memorial Sloan Kettering Cancer Center

Ichor Medical Systems Incorporated

Drew Hannaman

Symptoms and General Pathology

Recurrence

Antineoplastic Agents

Anti-Infective Agents

Temozolomide

Interferons

Peginterferon alfa-2b

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunologic Factors

pegylated interferon alfa

temozolomide

Wen-Jen Hwu, MD, PhD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.

OBJECTIVES:

* Determine the response rate in patients with advanced melanoma treated with temozolomide and pegylated interferon alfa.
* Determine the toxicity profile of this regimen in these patients.
* Determine the duration of disease response and overall survival of patients treated with this regimen.

OUTLINE: Patients are stratified according to CNS metastases (yes vs no).

Patients receive oral temozolomide once daily on weeks 1-6 and pegylated interferon alfa subcutaneously once weekly on weeks 1-8. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 23-61 patients (12-35 without CNS metastases and 11-26 with CNS metastases) will be accrued for this study within 18 months.

Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma

A Phase II Study of Temozolomide (Temodar) and Peglated Interferon Alfa-2B (PEGIntron) in the Treatment of Advanced Melanoma

National Cancer Institute (NCI)

Digestive System Diseases

Gland and Hormone Related Diseases

Syndrome

Esophageal Neoplasms

Pheochromocytoma

Carcinoma

Cholangiocarcinoma

Adenocarcinoma

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

Small Intestinal Adenocarcinoma

Thyroid Cancer, Medullary

Small Intestine Cancer

Conjunctival Melanoma

WDHA Syndrome

Hematinics

Gastrointestinal Agents

Herbal and Botanical

Melphalan

Liver Extracts

Pancrelipase

Pancreatin

Pancreatic Polypeptide

Immunosuppressive Agents

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

Delcath Systems Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation	NCT00471133	Melanoma (Skin) Intraocular Mel...	Xenogeneic Tyro... TriGrid Deliver...	18 Years -	Ichor Medical Systems Incorporated
Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma	NCT00027742	Intraocular Mel... Melanoma (Skin)	pegylated inter... temozolomide	18 Years -	Memorial Sloan Kettering 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.
Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma	NCT00027742	Intraocular Mel... Melanoma (Skin)	pegylated inter... temozolomide	18 Years -	Memorial Sloan Kettering Cancer Center
Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation	NCT00471133	Melanoma (Skin) Intraocular Mel...	Xenogeneic Tyro... TriGrid Deliver...	18 Years -	Ichor Medical Systems Incorporated

Spots Global Cancer Trial Database for intraocular melanoma