Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Lutetium Lu 177 dotatate

We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-\[DOTA 0, Tyr 3\] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET.

[177Lu] DOTA-TATE

Carmen A De los Reyes, Md

Well-differentiated neuroendocrine tumors (WDNETs) are uncommon neoplasms with an increasing number of new cases reported in the annual statistics of the Instituto Nacional de Cancerología (INC). The majority are advanced-stage presentations with limited chances of a complete surgical resection of the primary tumor, a clinical scenario where medical treatment options are also limited. In view of the characteristically defined expression of peptide receptors in WDNETs, radioactive molecular probes to target specific cellular receptors have been designed using radioisotopes with short range of penetration in tissues. We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-\[DOTA 0, Tyr 3\] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET. Selected patients matching inclusion criteria will be enrolled at the INC's Section of Endocrinology. Tumor response, treatment safety (side effects) and survival will be appraised. Data from clinical, biochemical and imaging follow-up will be periodically registered during treatment and until two years after the last infusion of 177Lu- DOTATATE. This phase II trial is justified because despite the fact that many preclinical and clinical studies have showed the potential usefulness of this novel palliative approach to treat patients with advanced-stage WDNETs there is a paucity of vigorous results to establish its efficacy as first-line treatment.

The Investigators have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-\[DOTA 0, Tyr 3\] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET.

Efficacy of 177-Lu-DOTA 0, Tyr 3 Octreotate

Efficacy of Peptide Receptor Radionuclide Therapy for Metastatic Inoperable Neuroendocrine Tumors Using 177-Lu-DOTA 0, Tyr 3 Octreotate

Response to palliative treatment with 177Lu- DOTATATE in patients with metastatic progressive low-grade neuroendocrine tumors defined by control size tumor, response time to reduction minimal parcial and complete tumor.

Measure the efficacy of 177Lu- DOTATATE to treat patients with metastatic progressive low-grade neuroendocrine tumors using clinical and imaging criteria such as tumor size.

Describe the side effects of the treatment with 177Lu- DOTATATE by clinical follow-up during and after therapy

describe the 2-year survival rate of patients treated with 177Lu- DOTATATE

Assess the quality of life of patients with metastatic progressive low-grade neuroendocrine tumors treated with 177Lu- DOTATATE during treatment defined by pain reduction and tolerability.

Instituto Nacional de Cancerologia, Columbia

Antineoplastic Agents

Capecitabine

Fluorodeoxyglucose F18

Somatostatin

Edotreotide

Edotreotide lutetium LU-177

Antimetabolites

Radiopharmaceuticals

Patients with 68Ga-DOTA- and 18F-FDG-PET-positive NET will receive a combination of intravenous 7.5 GBG (gigabequerel) 177Lu-DOTATOC for about 7 cycles in combination with capecitabine (4 cycles, cycle length 3 weeks, with one week without capecitabine, dosing 825 mg twice daily) and PRRT to a cumulative renal AD (absorbed dose) limit of 30 Gy and dosimetry-based PRRT.

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Intravenous infusion for about 7 treatment cycles with 7.5 GBq 177Lu-DOTATOC with an interval of 10 ± 2 weeks and PRRT to a cumulative renal AD limit of 30 Gy and dosimetry-based PRRT.

Standard treatment of 177Lu-DOTATOC with treatment for 4 cycles.

The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor).

The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.

177Lu-DOTATOC

Will be given orally with a dose of 825/m2 twice daily, starting on day 1 of each of the 4 first treatment cycles, cycle length 3 weeks.

There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. This trial aims to compare personalized PRRT to non-personalized PRRT in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future.

This is a randomized, open-label, controlled trial in which patients are assigned to either non-personalized treatment with 4 cycles of 7.5 gigabequerel (GBq) 177Lu-DOTATOC (TOC), or personalized treatment based on dual imaging. In the personalized arm patients are treated according to the results of the dual imaging at screening:

A. Patients with 68Ga-1,4,7,10-tetra-azacyclododecane-N.n,N,N-tetraacetic acid (DOTA)-positron emission tomography (PET)-positive but 18F-2-fluoro-2-deoxy-D-glucosefluorodeoxyglucose (FDG)-PET-negative NET will receive dosimetry-based PRRT only (dTOC) B. Patients with 68Ga-DOTA- and 18F-FDG-PET-positive NET will receive a combination of capecitabine and dosimetry-based PRRT (CAP-dTOC).

Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.

Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. An Open-label, Multicenter, Randomized Phase III Trial Comparing Safety and Efficacy of Personalized Versus Non-personalized Radionuclide Therapy With 177Lu (Lutetium)-DOTATOC.

Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.

Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 10 +/- 2 weeks.

Treatment-related adverse reactions graded according to CTCAE v.5.0.

Median OS defined as time from randomization to death of any cause.

Percent change in SLD from baseline (within 4 weeks before treatment) to time of best response.

All patients complete the Eastern Cooperative Oncology Group (EORTC) QoL (quality of life)-questionnaires GI- neuroendocrine tumors (NET)21.

AD to target tumor lesions in subjects with complete remission (CR), partial remission (PR), stable disease (SD) and progressive disease (PD) as best response, according to RECIST evaluations.

Correlation between cumulative median absorbed dose to target tumor lesions and time to progression, defined as time from randomization to radiological progression.

Cumulative median AD and biological effective dose (BED) to kidneys vs rate of grade 3-4 renal toxicity (estimated and measured GFR ( glomerular filtration rate).

Differences in resource utilization and treatment cost between the two treatment arms, in relation to the progressive free survival (PFS) and overall survival (OS).

Lund University Hospital

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Gastrointestinal Agents

Octreotide

Antineoplastic Agents, Hormonal

Hormones

Hormone Antagonists

Intravenous injections of DOTA-TOC. Repeated treatment cycles for responders, except in case of

* renal toxicity
* loss of patient transferability or
* denial of further treatment.

DOTA-TOC Treatment

Martin A Walter, MD, Dr.

The investigators aim to explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and long-term safety profile of systemic \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC treatment in metastasized neuroendocrine cancer patients. Adverse events are assessed according to the criteria of the National Cancer Institute. Survival analyses are performed using multiple regression models.

Background: Systemic treatment with the 90Yttrium (90Y) labeled, tetraazacyclododecanetetraacetic acid (DOTA) modified somatostatin analog Tyr3-octreotide (TOC) was introduced in 1998 (Otte et al. Lancet 1998). \[90Y-DOTA\]-TOC is administered intravenously and binds to the somatostatin receptor subtype 2, located on the surface of the tumor cell, and exerts its cytotoxic effects by β-irradiation. The treatment has moderate acute hematologic and nephrologic toxicity and has developed into a promising therapeutic tool for tumors expressing its target receptor (Iten et al. Clin Cancer Res 2007, Iten et al. Cancer 2009).

Study Aim: To explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer.

Study Hypothesis: Response to DOTA-TOC is correlated with prolonged survival.

Study Type: Clinical phase II, single-center, open-label trial

Patients: 1500 patients

DOTA-TOC in Metastasized Neuroendocrine Tumors

Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors

University Hospital, Basel, Switzerland

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Gallium 68 PSMA-11

Escalating doses of 0.75 GBq - 2.0 GBq of CTT1403

Escalating doses of 3.0 GBq - 9.0 GBq of CTT1403

Escalating doses of 0.75 GBq - 9.0 GBq will be administered in an accelerated to traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort. Patients meeting eligibility criteria with demonstrated cessation of disease progression will be offered a second dose of the study drug, CTT1403.

CTT1403

Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.

CTT1057

68Ga-PSMA-11

Beatrice Langton-Webster, PhD

Rahul Aggarwal, MD

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

This is a Phase 1, first-in-human dose escalation/dose expansion study evaluating escalating doses of CTT1403 in patients with PSMA-avid mCRPC with progressive disease on at least one androgen signaling inhibitor, followed by a dose expansion to further evaluate the safety, tolerability, efficacy and biological activity of CTT1403. CTT1403 is a PSMA-targeted 177Lu-labeled radiotherapy being developed for prostate cancer with a unique PSMA binding scaffold and an albumin binding moiety to extend circulation half-life. The PSMA binding scaffold is shared with CTT1057, a PSMA-specific PET diagnostic imaging agent shown in Phase 1 clinical trials to be specifically taken up by PSMA+ tumor. PSMA PET imaging by CTT1057 will be used diagnostically to select patients with PSMA-avid disease for treatment. The purpose of this study is to identify the dose limiting toxicity and recommended phase 2 dose of CTT1403. Eligible participants with demonstrated therapeutic benefit will be offered a second dose of study drug.

Prostate cancer is a disease only occurring in males.

A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

A Phase 1 Trial for Evaluation of Safety and 177Lu Radiation Dosimetry of CTT1403: A Peptidomimetic Inhibitor of Prostate Specific Membrane Antigen, in Metastatic Castration Resistant Prostate Cancer (mCRPC)

The dose-limiting toxicity was defined as any of the following:

1. Grade 4 neutropenia lasting \> 5 consecutive days
2. Grade 3 or 4 febrile neutropenia
3. Grade 4 thrombocytopenia lasting ≥ 7 days, or Grade 3 or 4 thrombocytopenia with clinically significant bleeding or requirement for platelet transfusion
4. Any nonhematologic, treatment-related AE ≥ Grade 3, with the exceptions of Grade 3 nausea, vomiting, diarrhea, non-clinically significant electrolyte abnormality, constipation, fever, fatigue, or skin rash that resolves to Grade ≤ 2 within 72 hours with optimal medical management
5. Any other treatment-related toxicity that results in delay of Cycle 2 administration of CTT1403 by \> 21 days and/or toxicity considered by the Investigator and Sponsor's medical representatives to be dose-limiting.

Changes in only the largest diameters (unidimensional measurment) of the tumor lesions are used in the RECIST v1.1 criteria. Data presented as RECIST Overall Response.

Organ dosimetry was assessed via SPECT/CT imaging until two imaging periods have been collected in which study drug cannot be detected by SPECT/CT. Time points included (2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1. Data calculated using OLINDA. Absorbed dose is calculated as single value wherein absorbed dose is proportional to the integral of activity over time.

The Brief Pain Index uses a scale of 0-10 to rate the severity of pain. A rating of 0 indicates no pain. A rating of 10 indicates the worst pain imaginable.

The distribution half-life and the elimination half-life of CTT1403 were calculated.

University of California, San Francisco

National Cancer Institute (NCI)

Cancer Targeted Technology

0.75 GBq Cohort

1.5 GBq Cohort

2.0 GBq Cohort

3.0 GBq Cohort

4.5 GBq Cohort

6.0 GBq Cohort

7.5 GBq Cohort

9.0 GBq Cohort

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The highest administered dose of CTT1403 was 9.0 GBq. At the 9.0 GBq dose, patients had to remain in-patient (in hospital) after administration due to continued radioactivity and for the safety of others until radioactivity dropped to an acceptable level as deemed by the hospital radiation safety committee.

Dr. Beatrice Langton-Webster, CEO

Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403

Number of patients with stable disease on Cycle 1-Day 35

Number of patients with progressive disease on Cycle 1-Day 35

Number of patients with stable disease on Cycle 2-Day 35

Number of patients with progressive disease on Cycle 2-Day 35

Number of patients with stable disease 30 days after last dose

Number of patients with progressive disease 30 days after last dose

Number of patients with stable disease 8 weeks post-treatment

Number of patients with progressive disease 8 weeks post-treatment

In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy of 177-Lu-DOTA 0, Tyr 3 Octreotate	NCT02125474	Neuroendocrine ...	[177Lu] DOTA-TA...	18 Years - 90 Years	Instituto Nacional de Cancerologia, Columbia
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.	NCT05387603	Neuroendocrine ...	177Lu-DOTATOC Capecitabine	18 Years -	Lund University Hospital
DOTA-TOC in Metastasized Neuroendocrine Tumors	NCT00978211	Neuroendocrine ...	DOTA-TOC Treatm...	-	University Hospital, Basel, Switzerland
A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer	NCT03822871	Prostate Cancer	CTT1403 CTT1057 68Ga-PSMA-11	18 Years -	Cancer Targeted Technology
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.	NCT05387603	Neuroendocrine ...	177Lu-DOTATOC Capecitabine	18 Years -	Lund University Hospital

Spots Global Cancer Trial Database for lutetium

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

Spots Global Cancer Trial Database for lutetium

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