Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Amino Acids

All Drugs and Chemicals

Arginine

arginine deiminase formulated with polyethlene glycol

ADI-PEG 20

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that have arginine. In this study, the primary efficacy variable will be assessment of tumor response rate.

PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy

Phase 2 Study of ADI PEG 20 in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy

Determined by response criteria for cutaneous and non-cutaneous malignant lymphoma

Progression free survival - time from start of therapy until proven progression or death Overall survival Time on treatment Disease control rate Determine the pharmacodynamics of ADI-PEG 20 Determine the immunogenicity of ADI-PEG 20

Polaris Group

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

ADI-PEG 20 Dose: 18 and 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)

Radiotherapy Dose: 60 Gy in 30 daily (Monday-Friday) fractions of 2 Gy each; to start within 5 weeks of surgery (diagnostic and/or resection)

Temozolomide Dose: 75 mg/m2 daily during radiotherapy; 150-200 mg/m2 for 5 days every 4 weeks (1 cycle) x 6 cycles during maintenance period Route of Administration: oral or intravenous

ADI-PEG20

Radiotherapy and TMZ are standard front-line therapy for newly diagnosed GBM.

John Bomalaski, M.D.

Kuo-Chen Wei, M.D.

Assess safety and tolerability of ADI-PEG 20 in combination with radiotherapy and Temozolomide in newly diagnosed GBM

ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme

Phase 1B Trial of ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme

RP2D will be determined by 3+3 method, depending on the Dose-Limiting Toxicity (DLT).

Progression free survival was defined as the period of time from randomization to date of tumor progression or death. Tumor measurements must be noted and tumor response status by investigator should be calculated.

Overall Survival was defined as the period of time from randomization to date of death due to any cause.

A pharmacokinetics measure of minimum ADI-PEG 20 concentration before the next ADI-PED 20 administration

Pharmacodynamics of ADI-PEG 20 in combination with radiotherapy and TMZ

Measurement of serum antibodies to ADI-PEG 20 to determine immunogenicity of ADI-PEG 20 in combination with radiotherapy and TMZ

Digestive System Diseases

Carcinoma

Stomach Neoplasms

Carcinoma, Hepatocellular

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Stomach Cancer

Dose: 36 mg/m2 given weekly

Route of Administration: Intramuscular (IM)

In combination with modified FOLFOX6, every 2 weeks, intravenous (IV) / IV bolus

ADI-PEG 20 plus modified FOLFOX6

James Harding, MD

Phase 1: Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies.

Phase 2: Assessment of the objective response rate (ORR), measured by RECIST 1.1 criteria as assessed by blinded independent central review (BICR).

Phase 1:The primary objective of the dose escalation portion of this study was to assess the safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil (5-FU), and oxaliplatin (mFOLFOX6) in advanced GI malignancies. The primary objective of the maximum tolerated dose (MTD) expansion phase (recommended phase 2 dose \[RP2D\]) of this study was to determine preliminary estimates of efficacy, measured by RECIST 1.1 criteria, for ADI-PEG 20 in combination with FOLFOX in hepatocellular carcinoma (HCC), gastro-esophageal cancer (GEC), and colorectal cancer (CRC).

Phase 2: The primary objective of this single arm trial is ORR. Based on a two-sided exact test of a one-sample proportion with an alpha of 0.05, under a presumed ORR of 22%, there is 80% power to yield 95% confidence interval of 15-26%, which will require 46 objective responses in 225 subjects. A futility analysis will be described in the Statistical Analysis Plan.

Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma

Phase 1/2 Study of ADI-PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies Focusing on Hepatocellular Carcinoma

The percent of subjects who exhibit each level of tumor response, measured by RECIST 1.1 criteria as assessed by blinded independent central review.

Time from the first dose until objective tumor progression or death from any cause

The time from first treatment with ADI-PEG 20 until death or censoring

the time in weeks between the first occurrence of objective response and the development of progressive disease or death

the proportion of subjects at each post-baseline assessment who exhibit tumor response of complete response, partial response or stable disease

Maximal percent changes of AFP during the course of study compared to AFP at baseline

Hematinics

Liver Extracts

Sorafenib

Ghassan Abou-Alfa, MD

Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in advanced Hepatocellular Carcinoma (HCC).

Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer

A Phase 1 Study of ADI PEG 20 Plus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Maeve Lowery, MD

Assessment of safety and tolerability of ADI-PEG 20 plus nab-Paclitaxel and Gemcitabine in subjects with Advanced Pancreatic Carcinoma.

Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer

Phase 1B Trial of ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Advanced Pancreatic Cancer

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the response rate, as determined by the revised International Working Group recommendations.

PH 2 ADI-PEG 20 Acute Myeloid Leukemia

Phase 2 Study of ADI-PEG 20 in Acute Myeloid Leukemia

* Time on treatment
* Overall survival
* Evaluate the response rate and correlate with patient disease burden, and type of disease.
* Determine the pharmacodynamics of ADI-PEG 20
* Determine the immunogenicity of ADI-PEG 20

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Melanoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Intraocular Melanoma

Neuroendocrine Tumor

Cisplatin

arginine deiminase formulated with polyethylene glycol

Siqing Fu, MD

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well known chemotherapy cisplatin, and the safety and potential efficacy of this combination will be explored in patients with cancers that require arginine.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy	NCT01910025	Non-Hodgkin's L...	ADI-PEG 20	20 Years -	Polaris Group
ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme	NCT04587830	Glioblastoma Mu...	ADI-PEG20 Temozolomide	20 Years - 75 Years	Polaris Group
Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma	NCT02102022	Advanced Gastro... Hepatocellular ... Gastric Cancer Colorectal Canc...	ADI-PEG 20 plus...	18 Years -	Polaris Group
PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy	NCT01910025	Non-Hodgkin's L...	ADI-PEG 20	20 Years -	Polaris Group
Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer	NCT02101593	Hepatocellular ...	ADI-PEG 20	18 Years -	Polaris Group
Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer	NCT02101580	Advanced Pancre...	ADI-PEG 20	18 Years -	Polaris Group
ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme	NCT04587830	Glioblastoma Mu...	ADI-PEG20 Temozolomide	20 Years - 75 Years	Polaris Group
PH 2 ADI-PEG 20 Acute Myeloid Leukemia	NCT01910012	Acute Myeloid L...	ADI-PEG 20	18 Years -	Polaris Group
Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma	NCT02102022	Advanced Gastro... Hepatocellular ... Gastric Cancer Colorectal Canc...	ADI-PEG 20 plus...	18 Years -	Polaris Group
Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma	NCT01665183	Cutaneous Melan...	ADI-PEG 20	18 Years -	Polaris Group

Spots Global Cancer Trial Database for argininosuccinate synthetase