Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Neoplasm Metastasis

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

All Drugs and Chemicals

Anti-Infective Agents

Gastrointestinal Agents

Bone Density Conservation Agents

Calcium

Plerixafor

Lenograstim

Calcium Carbonate

Calcium, Dietary

Radiopharmaceuticals

Hormones

Antacids

Anti-Ulcer Agents

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Dose Levels 1-3 will consist of treatment with radiopharmaceutical (153Sm-DOTMP) alone. If the maximally tolerated dose (MTD) has not been reached at Level 3, external beam radiotherapy will be added to each of Levels 4-6. Participants enrolled on Dose Levels 4-6 will be treated with external beam radiotherapy to all radiographically evident sites of disease. If an MTD has not been determined at Level 6, the study will end and Dose Level 6 will be declared the Recommended Phase 2 Dose.

Participants will be given prophylactic / supportive treatment protocols including Calcium Carbonate, mozobil, and neupogen injectable product.

For Levels 1- 3, the Day 1 dosages will be the same (0.5 millicurie (mCi)/kg 153Sm-DOTMP) for all levels but the Day 8 dosages will be 0.5, 1.0 and 3.0 mCi/kg respectively. For Levels 4, 5 \& 6, the Day 1 dosages will be the same (0.5 mCi/kg 153Sm-DOTMP) for all levels but the Day 8 dosages will be 3, 6, then 10 mCi/kg 153Sm-DOTMP respectively.

153Sm-DOTMP

The amount of radiation will be determined based on how much radiation was delivered to each tumor by the 153Sm-DOTMP, and will be targeted to 70 Gray (Gy)

External beam radiotherapy.

Calcium carbonate will be given to participants as prophylaxis against hypocalcemia..

Participants who require stem cell collection will be given Mozobil to help mobilize hematopoietic stem cells into the circulation for collection.

Mozobil

Participants who require stem cell collection will be given Neupogen to help mobilize hematopoietic stem cells into the circulation for collection.

Neupogen Injectable Product

David Loeb, MD, PhD

This is a dose finding study of a novel radiopharmaceutical agent, 153Sm-DOTMP. It will be studied alone and then in combination with external beam radiotherapy. The study design includes six cohorts, Levels 1-6. The first three cohorts of participants will receive 153Sm-DOTMP alone, and if this is determined to be safe, subsequent cohorts will receive the radiopharmaceutical followed by external beam radiotherapy.

This is a dose escalation study of a new radiopharmaceutical agent, 153Sm-DOTMP. Eligible participants will have osteosarcoma metastatic to bone, other solid tumors with bone metastases, or an unresectable localized osteosarcoma. Because of anticipated prolonged myelosuppression, participants will have a peripheral blood stem cell harvest. They will then be treated with 2 doses of 153Sm-DOTMP given 7 days apart. Twenty-four days after the initial dose, stem cells will be reinfused if needed. The first three cohorts of participants will receive only radiopharmaceutical. If Dose Level 3 is not the maximally tolerated dose (MTD), subsequent dose levels will include external beam radiotherapy, administered beginning on Day 15. The dose of external beam radiotherapy will be determined by dosimetry studies performed after each administration of study agent, and will be targeted to a tumoricidal dose of radiation. All participants will have disease re-evaluation 30 days following completion of all study treatments, and then at 4, 6, 8, and 12 months, unless they experience disease progression.

A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy

A Dose Finding Study of CycloSam® (153Sm-DOTMP) Combined With External Beam Radiotherapy to Treat High Risk Osteosarcoma and Other Solid Tumors Metastatic to Bone

The maximally tolerated dose (MTD) of 153Sm-DOTMP will be determined. The MTD will be defined as the dose that produces a dose limiting toxicity (DLT) in 30% of the participants. The dose limiting toxicity is the dosage at which side effects are serious enough to prevent an increase in dose or level of that treatment. DLTs will be defined as any grade 3, 4, or 5 non-hematologic toxicity experienced during a 42-70 day observation window.

The overall survival of participants with bone metastatic osteosarcoma will be determined. Overall survival is defined as the time from enrollment in the study until death. Observation begins at study enrollment and terminates upon death of the subject.

The time to progression of participants with bone metastatic osteosarcoma will be determined. Time to progression is defined as the time from study enrollment until the first radiographic evidence of progressive disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST). RECIST is a set of published rules that help define whether cancer patients improve, stay the same, or get worse with treatment. This study uses the revised RECIST 1.1 guidelines.

Participants will undergo radiographic evaluation 30 days after completion of all protocol therapy. The response of each tumor to treatment will be determined based on RECIST 1.1 criteria. Clinical response will be defined as either stable disease or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST 1.1 criteria.

Participants will undergo radiographic evaluation 4 months after completion of all protocol therapy. The response of each tumor to treatment will be determined based on RECIST 1.1 criteria. Clinical response will be defined as either stable disease or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST 1.1 criteria.

Participants will undergo radiographic evaluation 8 months after completion of all protocol therapy. The response of each tumor to treatment will be determined based on RECIST 1.1 criteria. Clinical response will be defined as either stable disease or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST 1.1 criteria

Participants will undergo radiographic evaluation 12 months after completion of all protocol therapy. The response of each tumor to treatment will be determined based on RECIST 1.1 criteria. Clinical response will be defined as either stable disease or a decrease in the size of the tumor by radiographic imaging (which may include CT or MRI) using RECIST 1.1 criteria.

National Cancer Institute (NCI)

Albert Einstein College of Medicine

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Antineoplastic Agents

Bortezomib

Adjuvants, Immunologic

Immunologic Factors

Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Granulocyte colony-stimulating factor (G-CSF)

Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

Siddhartha Ganguly, MD

Explore stem cell collection with or without bortezomib with in-vivo purging in multiple myeloma.

High dose chemotherapy with autologous stem cell transplant has resulted in improved overall survival and is currently considered an effective first line therapy applicable to the majority of patients with multiple myeloma. However disease relapse is inevitable and remains the primary cause of mortality in this cohort.

The purpose of this study is to estimate the proportion of subjects with plasma cell contamination of harvested stem cell product in standard and treatment arms. The study will explore whether or not in-vivo purging of malignant tumor plasma cells will improve progression free survival (PFS) for patients.

The study will consist of two groups:

Group A: Standard of Care (SOC) stem cell collection without in-vivo purging with bortezomib. Granulocyte colony-stimulating factor (G-CSF) and Mozobil used if needed.

Group B: Bortezomib 1.3mg/m\^2 will be given subcutaneously (SQ) on days -11 and -8 followed by Granulocyte colony-stimulating factor (G-CSF) on days -4 through -1 prior to stem cell harvest (day 0).

Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM)

An Exploratory Trial to Estimate the Proportion of Patients With Tumor Cell Contaminated, Flow Positive Leukapheresis Products Collected With and Without Bortezomib as In-vivo Purging Prior to Autologous Stem Cell Harvest for Multiple Myeloma

Estimate the proportion of subjects with plasma cell contamination (defined as \>0.01% and at least 100 cellular events) of harvested stem cell product by multi parametric flow cytometry (MFC) from patients with myeloma undergoing autologous stem cell collection 1) by standard of care mobilization using Granulocyte colony-stimulating factor (G-CSF) with or without Mozobil and 2) after two doses of bortezomib as in vivo purging plus standard of care using G-CSF with or without Mozobil.

Estimate the proportion of subjects who have a successful collection of stem cells (\> 2 million Cluster of Differentiation 34 (CD34) cells/Kg of body weight) for autologous transplant in both treatment groups.

Estimate the percentage of Cluster of Differentiation 34 (CD34) positive cells in circulating peripheral blood as a measure of mobilization on the days of collection.

Siddhartha Ganguly

Medical Doctor

Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).

NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

Stem Cell Collection Without In-vivo Purging With Bortezomib

Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.

There must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B

Bortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.

Granulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.

Mozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy	NCT03612466	Osteosarcoma Bone Metastases	153Sm-DOTMP External beam r... Calcium Carbona... Mozobil Neupogen Inject...	15 Years - 65 Years	Albert Einstein College of Medicine
Exploratory Trial to Estimate Proportion of Patients With Tumor Cell Contaminated Leukapheresis Products With and Without Bortezomib With In-vivo Purging - Multiple Myeloma (MM)	NCT02703779	Multiple Myelom...	Bortezomib Granulocyte col... Mozobil	18 Years -	University of Kansas Medical Center

Spots Global Cancer Trial Database for mozobil

Every month we try and update this database with for mozobil 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 mozobil

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