Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Osteosarcoma

Neuroblastoma

Rhabdomyosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Myosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Imiquimod

MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine: A regimen of three vaccines every two weeks. Each vaccine will contain 3,000,000-5,000,000 peptide pulsed dendritic cells. Imiquimod, a topical cream, will be applied to the vaccination site before and after each vaccination.

A regimen of three vaccines every two weeks. Each vaccine will contain 3,000,000-5,000,000 peptide pulsed dendritic cells. Imiquimod, a topical cream, will be applied to the vaccination site before and after each vaccination.

MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine

Kenneth G. Lucas, MD

The purpose of this study is to determine the safety and immunological effects of a vaccine for people diagnosed with high risk neuroblastoma, osteogenic sarcoma, and rhabdomyosarcoma. It is hypothesized that this vaccine could reduce the incidence of relapse.

MAGE -A1, MAGE- A3, and NY-ESO-1 are antigens that can be found with significant frequency on neuroblastoma, rhabdomyosarcoma, and osteogenic sarcoma, three relatively common solid tumors that in some cases can be associated with a high risk for relapse. In this study each subject will be screened for the presence of these antigens, and an individualized vaccine will be developed and administered using the subject's own dendritic cells (DC).

This study consists of two phases: a screening phase and a treatment/vaccine phase. First, eligible individuals will be consented into the screening phase. Tumor specimens will be tested by immunohistochemistry or RT-PCR for the presence of MAGE- A1, MAGE- A3, and NY-ESO-1. Those testing positive for one or more antigen can be consented for the treatment phase of the study. Blood will be drawn for DC culture, and approximately one month later a series of three vaccines will be administered at two week intervals. Subjects will receive a topical medication called imiquimod to the vaccine site prior to and following each injection, to help immune cells travel into the area. Study participation occurs over 18 months and also involves periodic physical examinations and blood draws.

A Vaccine Study for High Risk Cancers

A Phase 1 Study to Determine the Immunologic Effects of a MAGE- A1, MAGE- A3, NY-ESO-1 Vaccine in Patients With High Risk Neuroblastoma, Osteogenic Sarcoma, and Rhabdomyosarcoma

Penn State University

Sarcoma, Ewing

Sarcoma, Synovial

Ewing Sarcoma

Synovial Sarcoma

Azacitidine

Decitabine

Poly ICLC

Antimetabolites

Enzyme Inhibitors

Biological/Vaccine: Autologous dendritic cell vaccine with adjuvant

Week 1:

Decitabine (DAC): 10 mg/m2/day IV (Mon-Fri)

Weeks 2 and 3:

Vaccine: 3-5 E6 peptide pulsed DC (Mon)

Hiltonol applied topically to vaccine site before and after vaccination

Autologous dendritic cell vaccine with adjuvant

Kenneth G Lucas, MD

This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT) antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating chemotherapy.

For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.

Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma

A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma.

Tolerance to DAC, at at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles.

Assessment of tumor responses--complete or partial remission, stable disease, and disease progression--by CT/PET/MIBG or MRI after cycles 2 and 4.

Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassays.

Solving Kids' Cancer

University of Louisville

Immune System Diseases

Hypersensitivity

thoracic CT examinations for pre-treatment staging and/or subsequent post-treatment follow-up.

computed tomography

Osteosarcoma is regarded as most common malignant bone tumor in children and adolescents. Approximately 15% to 20% of patients with osteosarcoma present with detectable metastatic disease, and the majority of whom (85%) have pulmonary lesions as the sole site of metastasis. Previous studies have shown that the overall survival rate among patients with localized osteosarcoma without metastatic disease is approximately 60% to 70% whereas survival rate reduces to 10% to 30% in patients with metastatic disease. Though lately, neoadjuvant and adjuvant chemotherapeutic regimens can decline the mortality rate, 30% to 50% of patients still die of pulmonary metastases. Number, distribution and timing of lung metastases are of prognostic value for survival and hence computed tomography (CT) thorax imaging still plays a vital role in disease surveillance. In the last decade, the technology of multidetector CT scanner has enhanced the detection of numerous smaller lung lesions, which on one hand can increase the diagnostic sensitivity for lung metastasis, however, the specificity may be reduced. In recent years, deep-learning artificial intelligence (AI) algorithm in a wide variety of imaging examinations is a hot topic. Currently, an increasing number of Computer-Aided Diagnosis (CAD) systems based on deep learning technologies aiming for faster screening and correct interpretation of pulmonary nodules have been rapidly developed and introduced into the market. So far, the researches concentrating on the improving the accuracy of benign/malignant nodule classification have made substantial progress, inspired by tremendous advancement of deep learning techniques. Consequently, the majority of the existing CAD systems can perform pulmonary nodule classification with accuracy of 90% above. In clinical practice, not only the malignancy determination for pulmonary nodule, but also the distinction between primary carcinoma and intrapulmonary metastasis is crucial for patient management. However, most existing classification of pulmonary nodule applied in CAD system remains to be binary pattern (benign Vs malignant), in the lack of more thorough nodule classification characterized with splitting of primary and metastatic nodule. To the best of our knowledge, only a few studies have focuses on the performance of deep learning-based CAD system for identifying metastatic pulmonary nodule till now. In this proposed study, the investigators sought to determine the accuracy and sensitivity of one computer-aided system based on deep-learning artificial intelligence algorithm for detection and risk stratification of lung nodules in osteogenic sarcoma patients.

Accuracy of Deep-learning Algorithm for Detection and Risk Stratification of Lung Nodules

Feasibility Study: Accuracy and Sensitivity of Deep-learning Artificial Intelligence (AI) Algorithm for Detection and Risk Stratification of Lung Nodules in Osteogenic Sarcoma Patients

proportion of true results(both true positives and true negatives) among whole instances

true positive rate in percentage(%) derived by ROC analysis

true negative rate in percentage (%) derived by ROC analysis

FPs/scan in number (N) based on free-response receiver operating characteristic (FROC) analysis

Competitive performance metric (CPM) is a criterion used for CAD system evaluation. Based on FROC paradigm, CPM score is computed as an average sensitivity at seven predefined average false positive rates. CPM score ranges from 0 to 1, with higher CPM score indicating better CAD performance.

IBM China/Hong Kong Limited

Chinese University of Hong Kong

Professor

Musculoskeletal Diseases

Bone Neoplasms

Analgesics

Samarium Sm-153 lexidronam

Analgesics, Non-Narcotic

DAY 1 Tracer dose 153Sm-EDTMP administration (1 mCi/kg) SPECT/High-resolution CT at 4 hours. SPECT/CT (low resolution) at 24 and 48 hrs

DAY 7 Individualized treatment dose 153Sm-EDTMP administration (max 30 mCi/kg) SPECT scans at 4, 24 and 48 hours

DAY 21 (2 weeks following treatment dose) Auto-Stem cell infusion

DAY 40 (approx. two weeks after stem cell rescue) Initiate EBT upon count recovery

1 MONTH following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET

Subjects receive a "tracer" infusion of Samarium-153 EDTMP at 1 mCi/kg. 3D dosimetry using SPECT images are obtained post "tracer" infusion to determine the distribution of dose delivered to the tumor and surrounding normal tissues. "Tracer" activity will be applied to development of the external beam radiation (EBT) planning. Second "treatment" infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg.

Sm-EDTMP

Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.

Autologous Stem Cell Infusion

The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning.

After the "treatment" infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the EBT portion of the treatment plan, as necessary.

External Beam Radiotherapy

Brian Ladle, MD, PhD

The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.

Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.

Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma

Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.

Number of patients experiencing any Grade 3-4 toxicity, as defined by CTCAE v4.0 and RTOG Cooperative Group Common Toxicity Criteria, during the trial intervention and follow-up.

National Cancer Institute (NCI)

Jazz Pharmaceuticals

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.

SmEDTMP/Autologous Stem Cell Infusion/RT

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The study had low enrollment - 4 patients. Those that did enroll had very late stage disease and the therapy provided on this trial was the last therapy given for all 4 patients. Of the patients that began therapy, only 1 completed planned therapy.

Dr. Brian H. Ladle

Percentage of Treated Participants With 6-month Progression Free Survival

Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.

External Beam Radiotherapy: The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning.

Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity

Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy to be delivered according to the judgement of the treating radiation oncologist.

Overall Study

Pembrolizumab

Antibodies

Immunomodulating Agents

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Pembrolizumab (MK-3475) 200 mg i.v. every 3 weeks for up to 35 cycles

Pembrolizumab is a humanized antibody used in cancer immunotherapy.

Kjetil Boye, MD

This is a phase II, single arm, open-label, interventional trial of pembrolizumab (MK-3475) in patients with osteosarcoma who have experienced disease relapse or progression after at least one line of systemic treatment, and who are not eligible for curative surgery.

Patients with osteosarcoma, who are not eligible for surgery of curative intent and have completed at least one line of systemic therapy, will be considered for treatment with pembrolizumab. Patients who are considered medically unfit for chemotherapy and where no other treatment options are believed to be of major benefit may also be considered. Patients will receive pembrolizumab for up to 35 cycles.

Patients, who have received 35 cycles of pembrolizumab or discontinued study treatment of another reason than progression, will in the follow-up period be assessed for safety and treatment-related toxicity (for up to 90 days), progression and survival.

Patients who have achieved a clinically meaningful response after 35 cycles of pembrolizumab, defined as complete response (CR), partial response (PR), and stable disease (SD) assessed by the Investigator by using RECIST, v1.1, and have not experienced any clinically significant toxicity of study treatment, may be considered for reintroduction of pembrolizumab, if progression is detected \> 8 weeks after cycle 35.

Due to the low incidence of osteosarcoma, the inclusion rate is expected to be low, thus a Simon's two-stage design is suggested. Evaluation of efficacy and safety in stage one will be performed after the first 12 patients have been treated for 18 weeks:

* In case of ≤2 responders; the trial ends.
* If ≥3 responders, the trial will continue into stage II to a total number of 25 patients.

A Study of Pembrolizumab in Patients With Relapsed Or Metastatic Osteosarcoma Not Eligible for Curative Surgery

PROMO: A Phase II Study of Pembrolizumab in Patients With Relapsed Or Metastatic Osteosarcoma Not Eligible for Curative Surgery

The percentage of patients with unresectable osteosarcoma who have achieved clinical response; complete response (CR), partial response (PR), or stable disease (SD) at 18 weeks as assessed using RECIST v1.1.

The percentage of patients with unresectable osteosarcoma who have achieved objective response during treatment; complete response (CR), partial response (PR), as assessed using RECIST v1.1.

To evaluate the safety and tolerability of pembrolizumab in patients with osteosarcoma.

To evaluate health-related quality of life changes from baseline in patients with osteosarcoma, receiving pembrolizumab, using EORTC QLQ-C30.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Vaccine Study for High Risk Cancers	NCT00944580	Neuroblastoma Rhabdomyosarcom... Osteogenic Sarc...	MAGE-A1, MAGE-A...	1 Year - 70 Years	Penn State University
Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma	NCT01241162	Neuroblastoma Ewings Sarcoma Osteogenic Sarc... Rhabdomyosarcom... Synovial Sarcom...	Autologous dend...	1 Year - 24 Years	University of Louisville
Accuracy of Deep-learning Algorithm for Detection and Risk Stratification of Lung Nodules	NCT04022512	Osteogenic Sarc...	computed tomogr...	- 18 Years	Chinese University of Hong Kong
Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma	NCT01886105	Metastatic Oste...	Sm-EDTMP Autologous Stem... External Beam R...	10 Years - 65 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Study of Pembrolizumab in Patients With Relapsed Or Metastatic Osteosarcoma Not Eligible for Curative Surgery	NCT03013127	Osteosarcoma	Pembrolizumab	18 Years -	Oslo University Hospital
A Study of Pembrolizumab in Patients With Relapsed Or Metastatic Osteosarcoma Not Eligible for Curative Surgery	NCT03013127	Osteosarcoma	Pembrolizumab	18 Years -	Oslo University Hospital
A Vaccine Study for High Risk Cancers	NCT00944580	Neuroblastoma Rhabdomyosarcom... Osteogenic Sarc...	MAGE-A1, MAGE-A...	1 Year - 70 Years	Penn State University

Spots Global Cancer Trial Database for osteogenic sarcoma