Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

OSE-279 100mg

OSE-279 300mg

OSE-279 500mg

Caroline Chevalier, MSc, MPH

Elena Medko, MD

This is a phase 1/2, multicenter, dose-finding and dose expansion study of OSE-279, a PD-1 blocking monoclonal antibody, in subjects with advanced solid tumors or lymphomas.

Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas

A Multicenter, Phase 1/2, Dose-finding and Dose Expansion Study of OSE-279, a PD-1 Blocking Monoclonal Antibody, in Subjects With Advanced Solid Tumors or Lymphomas

Occurrence of dose limiting toxicity (DLT)

Objective Response Rate (ORR): complete response (CR) and partial response (PR), based on RECIST 1.1/RECIL and iRECIST

Disease Control Rate (DCR): complete response (CR), partial response (PR) and stable disease (SD) based on RECIST 1.1/RECIL and iRECIST

OSE Immunotherapeutics

Symptoms and General Pathology

Wounds and Injuries

Gland and Hormone Related Diseases

Digestive System Diseases

Carcinoma

Hyperthermia

Fever

Adrenocortical Carcinoma

Peritoneal Neoplasms

Neoplasms, Glandular and Epithelial

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Adenocarcinoma

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Antineoplastic Agents

Anti-Infective Agents

Cisplatin

Sodium thiosulfate

Antidotes

Protective Agents

Antioxidants

Antitubercular Agents

Anti-Bacterial Agents

Chelating Agents

Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin

Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.

Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.

Cytoreductive surgery

sodium thiosulfate will be given to limit the toxicity of cisplatin

sodium thiosulfate

Jeremy L Davis, M.D.

Background:

- Adrenocortical carcinoma (ACC) is a rare tumor of the adrenal gland. Few people who develop this disease live more than 5 years after being diagnosed. Those whose tumors have spread inside their abdomen may have an especially poor outcome. In these cases, traditional chemotherapy is not very effective. One possible new treatment is aggressive surgery with heated chemotherapy. This type of treatment has been more effective for other types of cancer in the abdomen. Researchers want to see this if approach can improve the outcomes of people with ACC.

Objectives:

- To test the safety and effectiveness of surgery and heated chemotherapy for ACC.

Eligibility:

- Individuals at least 18 years of age who have advanced ACC.

Design:

* Participants will be screened with a physical exam and medical history. Blood samples will be collected. Heart function tests will be given. Imaging studies will be used to locate the surgical sites before the operation.
* Participants will have surgery to remove ACC tumor tissue. After the tumors have been removed, they will have heated chemotherapy with cisplatin. The heat may help weaken any remaining cancer cells and make them easier to destroy. It will also focus the treatment on the tumor sites, rather than the whole body.
* Participants will recover in the hospital for several days after surgery. They will have regular follow-up visits to monitor the outcome of the surgery.

Background:

* Adrenocortical carcinoma (ACC) is a rare tumor with an incidence of 1.5 to 2 per million people per year and has a very poor prognosis with an overall 5-year mortality rate of 75 - 90% and an average survival from the time of diagnosis of 14.5 months.
* The treatment of choice for a localized primary or recurrent tumor is surgical resection. For unresectable metastatic or recurrent disease, mitotane, aminoglutethimide, metapyrone, and ketoconazole are used.
* Cisplatin is one of the most effective chemotherapeutic agents for ACC. In the Surgery Branch we have conducted Phase I and II trials using heated intraperitoneal (IP) chemotherapy with cisplatin for primary peritoneal mesothelioma, low grade appendiceal adenocarcinoma, ovarian malignancies, and high grade adenocarcinoma of the gastrointestinal tract. Synergy has been demonstrated for cisplatin and hyperthermia.
* The purpose of this trial is to determine if an aggressive surgical approach with intraperitoneal administration of heated cisplatin when tumor volume is minimal, can impact and improve on progression free survival.

Objectives:

- To determine IP progression free survival after optimal debulking and heated IP chemotherapy with cisplatin in patients with IP spread of adrenocortical cancer

Eligibility:

- Histologically proven ACC evaluable by computed tomography (CT) imaging with the majority of disease confined to the peritoneal cavity and surgically resectable to a residual size of less than 1 cm or amenable to radiofrequency ablation in patients who are \> 18 years of age.

Design:

- This is a classic phase 2 trial to determine efficacy of this therapeutic strategy in ACC. Patients will undergo cytoreductive surgery to achieve a CCR of 0 or 1.

Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.

Patients will be evaluated by associate investigators in coordination with the Principal Investigator for eligibility. Due to its exploratory nature, up to 30 patients may be enrolled to obtain 24 evaluable patients. (Patients must undergo successful debulking and HIPEC to be considered evaluable.)

Surgery and Heated Chemotherapy for Adrenocortical Carcinoma

Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

Amount of time subject survives without intraperitoneal disease progression after treatment. Disease progression is defined as imageable tumor nodules or increasing ascites persistent on computed tomography (CT) scan as interpreted by the official interpretation of the imaging studies.

Patients who died following the HIPEC procedure. The HIPEC is a surgical procedure in which two large bore catheters are inserted in the abdominal wall over the liver and pelvis. The physician closes the abdominal fascia and the catheters are connected to a perfusion circuit. The temperature of the catheters is carefully monitored while the physician ensures the perfusion is distributed properly by manually moving the abdomen.

Percentage of participants who are alive after treatment.

QOL characteristics were collected using The Functional Assessment of Cancer Therapy-Colorectal Quality of Life (QOL) questionnaire version 4, a validated survey that interrogates physical, emotional, functional, and social well being in cancer related issues on a 5-point scale. Scores range from 0 to 108 points. Higher scores are consistent with a better outcome.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

National Cancer Institute (NCI)

Principal Investigator

Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin

Cisplatin: Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.

Cytoreductive surgery: Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.

sodium thiosulfate: sodium thiosulfate will be given to limit the toxicity of cisplatin

Cytoreductive Surgery Followed by HIPEC

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Stage I

Stage II

Stage III

Stage IV

Unknown

American Joint Committee on Cancer (AJCC) - Tumor Stage I-IV with Stage I being the least advanced cancer with the best prognosis, and Stage 4 being the most advanced cancer with the worst prognosis.

Tumor Stage (AJCC) at Diagnosis

Dr. Jeremy Davis

One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.

Intraperitoneal Progression Free Survival (PFS)

Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure

Nine patients underwent cytoreduction and HIPEC, including one patient who recurred and was re-treated (n = 10 treatments). One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.

Percentage of Participants Who Survived 5-years Post Treatment

Prior to surgery

6 weeks after surgery

3 months after surgery

One patient could not be optimally cytoreduced for hyperthermic intraperitoneal chemotherapy (HIPEC) and therefore did not receive intraperitoneal chemotherapy.

The Functional Assessment of Cancer Therapy-Colorectal Quality of Life (FACT-G) (QOL) Score Prior to Surgery, 6 Weeks After Surgery, and 3 Months After Surgery

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Overall Study

Chordoma

Neoplasms, Germ Cell and Embryonal

Barbara (BJ) Thomas, R.N.

Brigitte C Widemann, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

Chordoma is a rare type of bone cancer. It occurs in the skull base or spine. Researchers want to study people with chordoma in different ways. They hope this will help them design better future treatments and supportive care studies for this disease.

Objective:

To learn more about chordoma by looking at its clinical course, how it appears on imagine scans, and how it responds to therapies and treatments.

Eligibility:

People ages 2 and older with chordoma who are enrolled in NCI protocol 19-C-0016

Design:

Participants will be screened with their medical history.

Participants will have a visit to examine their disease. This will include:

* Physical exam
* Neurologic exam
* CT scan and MRI: Participants will lie on a table. The table will slide into a machine. The machine will take pictures of the body.

Participants will have other tests every 6-12 months:

* Smell test
* Surveys to assess their emotional, physical, and behavioral well-being and needs
* Cognitive function tests

Participants or their home doctors will be contacted every 6 12 months. They will be asked to provide information about their disease. This could include test results and imaging evaluations.

Some participants may be asked to come to the clinic for more visits.

Background:

* Chordomas are a rare tumor with an incidence of 325 new cases per year in the United States. Pediatric chordomas are very rare and comprise only 5% of all chordoma cases.
* The standard therapy for localized primary or recurrent chordomas is surgical resection. However, complete surgical resection is often not possible due to the location of the

chordoma.

-For chordomas that cannot be surgically resected, treatment options are limited. Currently,

no standard therapy approach exists for recurrent chordomas. In addition, there are no FDA approved medical therapies for chordoma.

* The natural history of pediatric and adult chordoma is incompletely understood. Patients with chordoma seek expert advice in the management of their care.
* The NCI has basic and clinical expertise and research interest in chordoma. The planned natural history study as part of the NCI POB Rare Tumor Patient Engagement Network (RTPEN) will allow for comprehensive evaluation and recommendations to these patients while longitudinally collecting clinical, epidemiologic and biological data.

Objective:

-To characterize the natural history of chordoma, including clinical presentation and patterns of disease progression.

Eligibility:

* Subjects with histologically documented chordoma.
* Age greater than or equal to 2 years old

Design:

-This protocol is a subprotocol to protocol 19-C-0016: Natural History and Biospecimen

Acquisition Study for Children and Adults with Rare Solid Tumors . After enrollment on the master protocol and undergoing evaluations detailed, patients will be enrolled on this subprotocol specific for chordoma.

-Medical histories will be documented, and patients followed throughout the course of their disease, with particular attention to patterns of disease recurrence and progression, response to therapies, duration of responses and patient reported outcomes. Tumor growth rates will also be calculated throughout the course of the disease.

Children and Adults With Chordoma

Natural History Study of Children and Adults With Chordoma

.All IPD recorded in the medical record will be shared with intramural investigators upon request.

Natural history of chordoma, including clinical presentation and patterns of disease progression

Teratoma

Brian Kogon, MD

Kirk R Kanter, MD

Paul M. Kirshbom, MD

The purpose of this study is to do a literature review and combine all of the cases of the intrapericardial teratoma tumor and see if some conclusions can be made about this rare tumor in children.

We excised an intrapericardial teratoma tumor out of a child approximately one month ago.

This is a very uncommon tumor overall, and even more uncommon in children. The majority of reports in the literature are single case reports

I would like to report ours, as well as do a literature review to combine all of the cases and see if some conclusions can be made about this rare tumor in children.

Rare Tumor Case Review

Children's Healthcare of Atlanta

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Prostatic Neoplasms

Stomach Neoplasms

Sarcoma

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Urinary Bladder Neoplasms

Carcinosarcoma

Mixed Tumor, Mullerian

Leiomyosarcoma

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Fallopian Tube Cancer

Malignant Mixed Mullerian Tumor

Herbal and Botanical

Poly(ADP-ribose) Polymerase Inhibitors

Rucaparib

Enzyme Inhibitors

Cola

Eligible participants will be enrolled in either Cohort A or Cohort B.

Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.

Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.

Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).

Kim Reiss-Binder, MD

A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.

A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes

A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes

De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations.

Data will be provided by Clovis Oncology.

Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).

Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.

Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks.

Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.

Measure of clinical benefit, defined as the duration from study enrollment to death.

pharmaand GmbH

Adverse events are reported for the Safety Population, defined as participants who received at least one dose of protocol-specified treatment.

Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

Rucaparib Cohort A

Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

Rucaparib Cohort B

Total

Kim Reiss Binder

Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants).

Best Overall Response Rate by Investigator

No data were collected as the independent radiology review was not performed.

Overall Response Rate by Independent Radiology Review

Participants with a deleterious mutation in one of the following genes: BRD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

Duration of Response

Disease Control Rate

Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment.

Progression-free Survival

Overall Survival

Number of Participants Experiencing Treatment-emergent Adverse Events

Pharmacokinetics data not collected due to early study termination.

Steady State Minimum Concentration [Cmin]

Sarcoma, Synovial

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Synovial Sarcoma

Lauren Gutstein

James Robinson

Theodore Laetsch, MD

The purpose of this study is to collect and store data and samples for future research to attempt to improve outcomes for patients with synovial sarcoma. The future research will involve various types of genetic testing.

Participants will be asked to allow access to medical records and leftover tumor tissue and may be asked to give a blood or saliva sample. Participants will also be asked to completed questionnaires about their medical history and may be contacted every 6 to 12 months for updates for up to 10 years.

This study will enroll patients with a diagnosis of Synovial Sarcoma.

Following consent, demographic, clinical, treatment and outcome data will be collected from an interview and/or online survey. This will include a request for contact information for the subject's treating hospitals/physicians and a release of records request to obtain medical records.

At approximately 6-12 month intervals for up to 10 years after initial diagnosis and/or relapse, subjects and/or their treating hospitals may be contacted to provide updates on treatment and outcomes.

Tumor samples may be collected from residual material obtained during clinically indicated procedures occurring before or after consent to this study. No additional material will be collected or procedures performed solely for the purpose of this study.

Blood may be collected at the participant's local institution at the time of a clinically indicated blood draw and/or saliva or a buccal swab may be collected as a germline sample and for analysis of circulating free DNA (cfDNA) and/or circulating tumor cells (CTCs).

Genetic testing may be performed on tumor and germline samples submitted by subjects. Results will only be returned if deemed clinically significant.

Samples may include tumor tissue and its excipients (DNA, RNA, protein), blood, saliva, and/or buccal swabs.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dose-finding and Dose Expansion Study of OSE-279 in Subjects With Advanced Solid Tumors or Lymphomas	NCT05751798	Solid Advanced ... Lymphoma	OSE-279 100mg OSE-279 300mg OSE-279 500mg	18 Years -	OSE Immunotherapeutics
Surgery and Heated Chemotherapy for Adrenocortical Carcinoma	NCT01833832	Adrenocortical ... Peritoneal Carc...	Cisplatin Cytoreductive s... sodium thiosulf...	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Children and Adults With Chordoma	NCT03910465	Chordoma		2 Years -	National Institutes of Health Clinical Center (CC)
Rare Tumor Case Review	NCT00229879	Intrapericardia... Tumors		-	Children's Healthcare of Atlanta
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes	NCT04171700	Solid Tumor	Rucaparib	18 Years -	pharmaand GmbH
Rare Tumor Case Review	NCT00229879	Intrapericardia... Tumors		-	Children's Healthcare of Atlanta
Synovial Sarcoma Registry / Biospecimen Repository	NCT05910307	Synovial Sarcom...		-	Children's Hospital of Philadelphia
Optimal Methods of Disease Progression and Survival Analysis in Children and Adults Patients With Adrenocortical Cancer (ACC)	NCT04358107	Adrenocortical ...		-	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for rare tumor

Every month we try and update this database with for rare tumor 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 rare tumor

Every month we try and update this database with for rare tumor 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 rare tumor 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.