Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Micronutrients

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Folic Acid

Vitamin B Complex

Exatecan

Folinic Acid

Folate

Vitamin B9

Dose Escalation: Escalating doses of ELU001

Folic-acid functionalized C'Dot-Drug-Conjugate (FA-CDC)

ELU001

This research study was planned to focus on a rare type of acute myeloid leukemia (with the subtype CBFA2T3::GLIS2 that overexpresses folate receptor alpha (FRα) (a protein on the surface of leukemia cells)) that has relapsed or is refractory. Relapse means the cancer has come back after treatment. Refractory means the cancer does not respond to treatment.

This study was planned as a Dose Escalation Safety Study to identify the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D). This study will also evaluate the tolerability of ELU001.

ELU001 is not a drug approved by the FDA (Food and Drug Administration) yet.

ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML

Dose Escalation Study to Evaluate the Safety and Tolerability of ELU001 in Pediatric Patients Who Have Relapsed and/or Refractory CBFA2T3::GLIS2 Positive Acute Myeloid Leukemia

Establish the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of ELU001 in pediatric patients with relapsed or refractory CBFA2T3::GLIS2 positive AML.

Proportion of evaluable patients having achieved at least one of the following

* Complete Remission per IWG (CRIWG)
* Complete Remission With Partial Recovery of Platelet Count (CRp)
* Complete Remission with Incomplete Blood Count Recovery (CRi)
* Complete Remission for Minimal Residual Disease (CRm)

Duration of Complete Remission from CRIWG/CR/CRp/CRi to hematological relapse or death from any cause, whichever comes first

Measure the concentration of ELU001 in the blood.

This includes - Maximum Observed Concentration (Cmax), Time After Dosing at which Maximum Observed Concentration of Drug is Observed (tmax), Area Under the Curve to the End of the Dosing Period (AUC0-tau), and Area Under the Curve to the Last Measurable Concentration (AUC0-t), will be estimated. Other PK parameters, e.g., Terminal Elimination or Disposition Half-Life (T½), Volume of Distribution (Vd), Clearance Rate (CL), and C'Dot, payload on C'Dot

Percent incidence of Anti-Drug Antibodies (ADA) formation in the blood assessed from baseline until End-of-Treatment (EOT).

Elucida Oncology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Stan Kaye, Professor

The folate receptor (FR) is a cell marker that is over expressed on the cell surface of certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however in these normal tissues the FR is usually located on the tissue surface that is inaccessible to circulating drugs. As such, drugs which target the FR may potentially be used to achieve anti-tumour efficacy whilst reducing toxicity to normal tissues. Therefore the ability to measure FR levels from different cancer types may help to select patients who are most likely to benefit from treatment with FR targeted therapies. One such drug BGC 945 is currently being tested in preclinical study at The Institute of Cancer Research

A method has been developed in the laboratory which has been able to measure FR obtained from cancer cells in culture that has been added into blood. We would like to study if this method can measure FR in plasma and serum obtained from patients with ovarian cancer. We would also like to analyse plasma and serum samples obtained from healthy volunteers to determine if they have any appreciable levels of FR, which can then be compared to the measurements obtained from cancer patients.

Measurement of the Folate Receptor in Blood

Royal Marsden NHS Foundation Trust

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Neoplastic Cells, Circulating

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neoplasm Metastasis

Neoplastic Processes

Leucovorin

Fluorouracil

Oxaliplatin

Liver Extracts

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Patients who will receive FOLFOX4 chemotherapy after liver resection

No adjuvant therapy after liver resection

FOLFOX4 (OXA 85 mg/m2 intravenously \[IV\] on day 1; LV 200 mg/m2 IV from hour 0 to 2 on days 1 and 2; and FU 400 mg/m2 IV bolus at hour 2, then 600 mg/m2 over 22 hours on days 1 and 2, once every 2 weeks.All patients in the treatment group will receive FOLFOX4 at most 12 times beginning from the 4th week after liver resection.

FOLFOX4(infusional fluorouracil [FU], leucovorin [LV], and oxaliplatin [OXA]).

The aim of this study is to analyze the therapeutic effect of postoperative adjuvant chemotherapy with FOLFOX4 after hepatocarcinoma resection based on folate receptor-positive circulating tumor cells. Patients receiving curative resection (R0) were randomized to postoperative FOLFOX4 group and no FOLFOX4 group. The time to recurrence, the overall survival as well as the incidence of complications after therapy was observed to confirm the role of postoperative adjuvant therapy of FOLFOX4.

Hepatocellular carcinoma (HCC) is the third leading cause of cancer death globally. Hepatectomy remains the most widely practiced radical treatment for HCC despite having a high associated recurrence rate, approximately 70% at 5 years after surgery, which often hampers further improvement in survival for these patients. And until now although a lot of different adjuvant therapies had been tried in the clinic, but their role in preventing recurrence remain controversial. As a research of a phase Ⅲ randomize study showed that FOLFOX4 (infusional fluorouracil \[FU\], leucovorin\[LV\], and OXA) served as palliative chemotherapy can induce higher overall survival, progression-free survival and response rate comparing to doxorubicin in patients with advanced hepatocellular carcinoma from Asia. The safety data was also acceptable. The chemotherapy of FOLFOX has been accepted by many guidelines and recommended for systematic treatment of advanced HCC. However, the effect of this systemic chemotherapy for recurrent HCC after partial hepatectomy remains to be investigated.

Circulating tumor cells (CTC) have played an important role in early diagnosis of tumors, monitoring of recurrence and metastasis, judgment of patient prognosis, and guidance of postoperative adjuvant treatment. CTC counts can be used to assist diagnosis and evaluation of postoperative prognosis. Previous studies have also shown that folate receptors (FR) are highly expressed in HCC. The detection of circulating tumor cells based on folate receptor (FR+CTC) has been proved to be a sensitive and effective method for detecting CTC.

Patients with HCC who received curative liver resection and with the preoperative FR+CTC level higher than 18.4FU/3mL were randomly assigned 1:1 by the doctors to receive placebo(control group) or FOLFOX4 (treatment group). All patients in the treatment group received FOLFOX4 at most 12 cycles beginning from the 4th week after liver resection. The outcomes of patients were evaluated during the 3-years follow up.

A Trial of Adjuvant Therapy After Hepatocarcinoma Resection Based on Folate Receptor-positive Circulating Tumor Cells

A Randomized Controlled Study on the Effect of Postoperative Adjuvant Chemotherapy With FOLFOX4 After Hepatocarcinoma Resection Based on Folate Receptor-positive Circulating Tumor Cells

the time from randomization to documented progression

Eastern Hepatobiliary Surgery Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Adenocarcinoma of Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Adenocarcinoma

This cohort will receive the contrast agent

This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery

EC17 imaging contrast agent

Colleen Gaughan, MD

The goal is to improve surgery by preventing tumor cells from being left behind at the time of surgery. This includes finding residual tumor cells in the wound after surgery.

The goal is to improve the intraoperative identification of tumor cells at positive margins and regional metastases that may be missed by a surgeon during a pulmonary resection. Improved identification of tumor cells will result in superior disease clearance and more accurate clinical staging. The investigators hypothesize that targeted fluorescent imaging during surgery will improve identification of positive margins and metastases. Since folate receptor alpha (FR ) is expressed on 55% of resectable lung cancer, the investigators will utilize a fluorescent probe that targets these tumors. As real-time imaging provides more information to the surgeon, more personalized and directed operations can be conducted. This work will allow for more preservation of normal tissue, decreased morbidity, decreased surgical time, increased surgical confidence, improved cancer detection, decreased unnecessary surgery and ultimately improved tumor free survival. This technology should transform clinical surgery from an art that depends fully on the human factor to a procedure that has precision and fail safes.

Intraoperative Imaging of Pulmonary Adenocarcinoma

Percentage of surgeries which detect tumor cells at the surgical margin

Number of residual tumor cells in the lymph nodes detected via intraoperative imaging of a FR-targeted fluorescent contrast agent

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ELU001 in Pediatric Subjects Who Have Relapsed and/or Refractory CBFA2T3-GLIS2-positive AML	NCT05622591	Acute Myeloid L... AML, Childhood Relapsed Pediat... Refractory Pedi...	ELU001	1 Month - 9 Years	Elucida Oncology
Measurement of the Folate Receptor in Blood	NCT00838747	Healthy		18 Years -	Royal Marsden NHS Foundation Trust
A Trial of Adjuvant Therapy After Hepatocarcinoma Resection Based on Folate Receptor-positive Circulating Tumor Cells	NCT04521491	Hepatocellular ...	FOLFOX4(infusio...	18 Years - 80 Years	Eastern Hepatobiliary Surgery Hospital
Intraoperative Imaging of Pulmonary Adenocarcinoma	NCT02653612	Lung Cancer	EC17 imaging co...	18 Years - 99 Years	VA Office of Research and Development

Spots Global Cancer Trial Database for folate receptor