Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Frailty

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

brentuximab vedotin will be administered at an initial dose of 1.8 mg/kg every 3 weeks as a 30-minute outpatient i.v. infusion. A maximum of 16 cycles

An early phase II, single arm, two stage study, to investigate the level of activity, duration of response and tolerability of brentuximab vedotin (SGN-35), as a single agent, utilising a response adapted approach, in older, frailer or co-morbid patients with previously untreated Hodgkin lymphoma.

Opened Feb 2014 and will recruit over 18 months. Duration of treatment will be dependent on the patients' response (see schema below) with a maximum of 16 cycles over 48 weeks.

At the end of treatment patients will be assessed clinically at 3 months intervals and by CT scan at 15, 18, 24 and 36 months. For those still alive and disease free after 2 years, follow-up will be according to local practice.

Stage 1 will recruit 20 patients. If at least patients 8 respond after the initial 4 cycles of SGN-35 a further 10 patients will be recruited to stage 2.

In all cases brentuximab vedotin will be administered at an initial dose of 1.8 mg/kg every 3 weeks as a 30-minute outpatient i.v. infusion.

After baseline staging (including PET and CT scans (PET0 + CT0), performed on PET scanners approved for the purpose by The PET Imaging Centre at St Thomas'/Guy's), all eligible and consenting patients will receive an initial 4 cycles of brentuximab vedotin following which response and continuation of brentuximab vedotin will be assessed by PET (PET4) in the first instance. Patients achieving CMR (Deauville score 1-3) will continue treatment. Patients achieving PMR (Deauville score 4,5 with uptake less than baseline) will also continue treatment. Patients achieving NMR (Deauville score 4,5 with no change in uptake from baseline) or PMD (Deauville score 4,5 with increased intensity of uptake compared to baseline and/or new lesions consistent with lymphoma) will stop brentuximab vedotin and be considered for alternative therapy.

CT4 will be performed for future comparison with CT8, CT12 and CT 16 (to exclude Progressive Disease (PD) and to correlate metabolic and radiological responses) and to inform continued treatment. Patients not achieving Deauville score 1-3 at PET 4 will also have a PET scan at completion of treatment (after 16 cycles or earlier if brentuximab vedotin discontinued for reasons other than PD)

In addition an exploratory PET scan will be performed after 2 cycles of brentuximab vedotin (PET2); investigators will be blinded to the results of PET2 which will not influence patient management in any way. All PET scans will be centrally reviewed for QA purposes by The PET Imaging Centre at St Thomas'/Guy's, under the supervision of Sally Barrington and Mike O'Doherty, using the framework developed for the recently completed RAPID and RATHL trials. CT scans after 4 cycles and at the end of treatment may also be reviewed.

After the initial 4 cycles of brentuximab vedotin, subsequent treatment will be response adapted according to PET scan result the following schedule:

* Those with a Complete Metabolic Response (CMR, Deauville Score 1, 2 or 3) at PET 4 will receive up to 12 additional cycles of brentuximab vedotin (maximum of 16 cycles) depending on no evidence of PD by a CT scan performed after each group of 4 cycles of brentuximab vedotin.
* Patients with a Partial Metabolic Response (PMR) at PET4 will receive up to 12 additional cycles of brentuximab vedotin (maximum of 16 cycles) depending on no evidence of PD on a CT scan performed after each group of 4 cycles of brentuximab vedotin.
* Patients with No Metabolic Response (NMR) will stop brentuximab vedotin and be considered for alternative therapy.
* Patients with progressive disease at any time as determined by either CT or PET scan performed after each group of 4 cycles of brentuximab vedotin or in response to clinical concerns will stop study treatment and receive subsequent therapy at investigator discretion. Clinical concerns over PD should be confirmed by either a CT or PET scan.
* Patients who come off treatment with brentuximab vedotin for any other reason (toxicity, patient decision, investigator advice) should have a CT scan performed for response assessment. In addition patients with Partial Metabolic Response at PET 4 should also have a PET scan performed.

All patients who have not progressed irrespective of how many cycles of brentuximab vedotin received will be clinically assessed every 3 months and have a CT scan at months 3, 6, 9, 12. These scan may take place during therapy. During follow-up CT scans will be performed 15, 18, 24 and 36 months from the start of treatment. For those still alive and disease-free after 3 years following start of treatment, follow-up will be according to local practice but data recorded must include date of progressive disease, type of any subsequent therapies, date and cause of death.

For patients who progress at any time, follow-up will be according to local practice but data must be recorded for 5 years form the start of treatment and must include date of progressive disease, type of any subsequent therapies, date and cause of death.

A Study of Brentuximab Vedotin in Patients With Hodgkin Lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity

BREVITY: A Phase II Study of Brentuximab Vedotin Using a Response Adapted Design in Patients With Hodgkin Lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity

Where appropriate secondary outcomes analysis will be repeated to explore differences between patients who continue treatment following PET4 due to CMR and those who continue treatment following PMR at PET4.

The number of patients achieving a CR at PET4 (after cycle 4) with confidence intervals (CIs) will be presented and assessed using the Simons 2-stage design criterion.

Numbers of patients in each CTCAE toxicity category will be reported. Dose intensity will be reported as the median dose intensity together with full range. The number of patients with dose interruptions, dose reductions and number discontinuing treatment will also be reported over the treatment period.

ORR based on the Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification will be presented as the number of patients in each response category (CR/PR), as well as overall.

Survival estimates (PFS) will be calculated using the Kaplan-Meier method. Median, 12, 24 and 60 month estimates will be presented with CIs. Causes of death will also be reported.

Survival estimates (OS) will be calculated using the Kaplan-Meier method. Median, 12, 24 and 60 month estimates will be presented with CIs. Causes of death will also be reported.

Deauville score after cycle 2 (blinded PET2) will be reported as the number of patients in each score category. Scores will also be categorised into complete response (DS=1, 2 or 3) or not complete response (DS=4,5) and reported as the number and proportion of patients in each category

Correlation coefficients will be reported to assess the association of DS after 2 cycles (at blinded PET2) with DS after 4 cycles (at PET 4) will be assessed by cox-regression modelling

Correlation coefficients will be reported to assess the association of DS after 2 cycles (at blinded PET2) with end of treatment response. The relationship will also be assessed by cox-regression modelling

Correlation coefficients will be reported to assess the association of DS after 2 cycles (at blinded PET2) with OS and also will be assessed by cox-regression modelling

Correlation coefficients will be reported to assess the association of DS after 2 cycles (at blinded PET2) with PFS and assessed by cox-regression modelling

Numbers of patients in each CIRS-G score at baseline will be reported.

Numbers of patients will be presented for common co-morbidities (ECOG and IPS) and any additional treatments administered following treatment with brentuximab vedotin

Leukaemia Lymphoma Research

Millennium Pharmaceuticals, Inc.

University of Birmingham

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Radiologic exams

Elizabeth Gerstner, MD

A standard treatment for glioblastoma is a combination of radiation and the drug temozolomide. This combination sometimes causing swelling (inflammation) of the brain tissue. When standard monitoring with MRI or CT scans is done within a few months of finishing treatment, it may be hard to tell if the scans are showing post-treatment brain inflammation or tumor growth and worsening of disease. Currently the only way to definitively distinguish inflammation from tumor growth is biopsy.

However, biopsy is an invasive procedure that is associated with risks. Having a non-invasive method to distinguish post-treatment inflammation from tumor growth can help improve care for patients with glioma.

For the PET scans in this research study, the investigators are using a radioactive substance called FLT (3'-deoxy-3'-\[F-18\] fluorothymidine), instead of the standard substance FDG (fluorodeoxyglucose). FLT gets absorbed by cancer cells but not by areas of inflammation. Because of that FLT may be better than FDG in differentiating cancer cells from inflammation.

An MRI scan will also be done at the same time as each of the 2 FLT-PET scans done for this research study. The two MRI scans performed will also help give more information about the patient's tumor that is not routinely provided with a routine clinical scan, such as blood flow through the tumor or metabolic activity in the tumor. The information from these special MRI scans may provide more information about the blood supply to the tumor and how this changes in response to treatment. In addition, the MRI scans along with the FLT-PET scans may help how to distinguish inflammation due to radiation therapy from tumor growth.

If you are eligible to participate in this study you will have a pre-treatment FLT-PET scan within 7 days before starting treatment with radiation and temozolomide.

Two intravenous catheters (IVs) will be placed for each scan. One IV will be used to inject the FLT for the PET scan and the contrast agent for the MRI scan. The second IV will be used to draw blood for research tests. The PET scan will take about 2 hours. The MRI scan will take about 60-75 minutes. They will be done simultaneously.

About 4 weeks after you finish radiation therapy you will have a second FLT-PET scan and MRI scan.

Evaluating Tumor Pseudoprogression With FLT-PET and MRI

A Pilot Study to Evaluate Tumor Pseudoprogression With FLT-PET and MRI

To determine if elevated FLT PET uptake 4 weeks after completion of chemoradiation is associated with early tumor growth rather than treatment effect in patients with newly diagnosed glioblastome treated with standard chemoradiation.

To clarify the impact of radiation and temozolomide chemotherapy on tumor cell proliferation.

To compare blood-derived kinetic parameters of tumor cell proliferation rate with image derived parameters of proliferation.

To examine the association of FLT uptake and MRI parameters, specifically contrast enhancement, perfusion, permeability, diffusion, and MR Spectroscopy.

Dana-Farber Cancer Institute

Massachusetts General Hospital

Principal Investigator

Neuroendocrine Tumors

Neuroendocrine Tumor

68Ga -DOTATATE PET scans

Ur Metser, M.D.

This is a research study to collect information regarding usefulness of positron emission tomography (PET) scans using a special dye called 68Ga-DOTATATE for patients with neuroendocrine tumours by determining the number of of patients whose clinical management was changed as a result of the scans.

When patients are suspected of having neuroendocrine tumours, they will usually undergo various imaging scans such as computed tomography (CT) scan and magnetic resonance imaging (MRI), and octreotide scintigraphy (octreoscan) to try to identify the primary tumour. During the patients' course of disease, they will continue to have various CT, MRI, and/or octreoscans. Sometimes, despite using scans, laboratory tests, and examination, it is still difficult to properly diagnose neuroendocrine tumours.

Doctors have found that most neuroendocrine tumours make too much of a hormone called somatostatin on their cell surface. Because of this doctors have been using positron emission tomography (PET) scans using a special contrast dye called 68Ga-DOTATATE in hopes of better diagnosing and managing neuroendocrine tumours. 68Ga-DOTATATE can label the cells that have somatostatin (such as neuroendocrine tumour cells) so that the PET scan can take better pictures and doctors can better diagnose and manage the disease.

However, despite 68Ga-DOTATATE PET scans showing promise, it is still not widely accessible. Because of this, researchers are creating a registry for patients who may need 68Ga-DOTATATE PET scans to:

* Identify their primary tumour where the doctor suspects is a neuroendocrine tumour
* Staging of the neuroendocrine tumour
* Restage the tumour prior to surgery/radiotherapy or help to assess the tumour where standard scans such as CTs, MRIs, or octreoscans are not properly showing your tumours despite other clinical or laboratory tests showing that your disease has progressed
* For other issues when confirmation of site of disease and/or disease extent may impact clinical management of the neuroendocrine tumour.

This registry help the participant's treating physician to obtain approval for the participant to undergo 68Ga-DOTATATE PET scans for their neuroendocrine tumour.

68Ga-DOTATATE PET for Management of Neuroendocrine Tumors

The Clinical Impact of 68Ga-DOTATATE PET in the Management of Patients With Neuroendocrine Tumors

Detection of additional disease and/or change in extent of disease after 68Ga-DOTATATE PET

To determine the proportion of patients with NET (or clinical suspicion of NET) in whom intended clinical management prior to PET is changed after 68Ga-DOTATATE PET.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Brentuximab Vedotin in Patients With Hodgkin Lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity	NCT02567851	Hodgkin Disease	Brentuximab Ved...	16 Years -	University of Birmingham
Evaluating Tumor Pseudoprogression With FLT-PET and MRI	NCT01105988	Glioblastoma	Radiologic exam...	18 Years -	Massachusetts General Hospital
68Ga-DOTATATE PET for Management of Neuroendocrine Tumors	NCT03873870	Neuroendocrine ...	68Ga -DOTATATE ...	14 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for pet scans

Every month we try and update this database with for pet scans cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for pet scans

Every month we try and update this database with for pet scans 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 pet scans 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.