Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Melanoma

Sarcoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Disease Attributes

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

Patients receive FACT complex-targeting curaxin CBL0137 IA over 15 minutes.

FACT Complex-targeting Curaxin CBL0137

Joseph Skitzki

This phase I trial studies best dose and side effects of CBL0137 in treating patients with extremity melanoma or sarcoma that has spread to other places in the body. Drugs, such as CBL0137, may work by binding to tumor cell deoxyribonucleic acid (DNA) to stop the cell from growing further.

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) and examine the dose-limiting toxicities of intra-arterial facilitates chromatin transcription (FACT) complex-targeting curaxin CBL0137 (CBL0137) in patients with advanced extremity melanoma or sarcoma.

SECONDARY OBJECTIVES:

I. To assess the tumor response in advanced melanoma and sarcoma patients treated with intra-arterial administration of CBL0137.

II. To define both response in-field (area of the limb distal to the infusion point) and out-of-field (any area proximal to the infusion point) in patients treated with CBL0137 based intra-arterial infusion.

III. Assess the pharmacokinetics of CBL0137 in the study population pre-and post CBL0137 intraarterial infusion.

IV. Assess tumor protein expression profiles before and after treatment with CBL0137.

TERTIARY OBJECTIVES:

I. To assess if the proposed treatment has any effect on quality of life as measured by the Functional Assessment of Cancer Therapy ? Melanoma (assessment tool also applicable to sarcoma).

OUTLINE: This is a dose-escalation study of FACT complex-targeting curaxin CBL0137.

Patients receive FACT complex-targeting curaxin CBL0137 intra-arterially (IA) over 15 minutes.

After completion of study treatment, patients are followed up at 2, 6 and 12 weeks, every 3 months for 12 months, then at 24 months.

CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma

A Single-Center Phase I Dose Escalation/Response Trial to Evaluate Safety, Tolerability, and Anti-Tumor Efficacy of Intra-Arterial CBL0137 for Patients With Advanced Extremity Melanoma or Sarcoma

Median and range baseline subscale and total QOL scores, as well as single item scores, will be presented, followed by mean change scores for subscales, the total scale and single items, compared between different study intervention groups.

The frequency of toxicities will be tabulated by grade across all dose levels. The frequency of toxicities will also be tabulated for the dose estimated to be the maximum tolerated dose.

Responses will be tabulated, and complete response rate will be estimated with its exact 80% confidence interval.

Changes in clinical laboratory values while receiving CBL0137

Incuron

Roswell Park Cancer Institute

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Ichthyosis, X-Linked

Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.

Hypofractionated Radiation Therapy

Quality-of-Life Assessment

Questionnaire Administration

Beverly A Guadagnolo

This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Shorter course hypofractionated pre surgery radiation therapy may be more convenient for patients with soft tissue sarcoma than a longer course of radiation therapy, and may result in fewer complications.

PRIMARY OBJECTIVES:

I. To determine, in patients with localized, resectable soft tissue sarcoma, whether there is a non-inferior major wound complication rate for patients receiving 42.75 Gy in 15 fractions over 3 weeks compared to historical controls who received 50 Gy in conventional fractionation over 5-6 weeks.

SECONDARY OBJECTIVES:

I. To determine whether local control rates among patients treated with 42.75 Gy in 15 fractions is similar to that observed in previous studies for patients treated with 50 Gy in conventional fractionation over 5-6 weeks.

II. To determine whether patterns of local relapse, relapse free survival, overall survival, or metastatic disease free survival for patients treated with 42.75 Gy in 15 fractions are similar to previously reported studies.

III. To determine where there is a difference in pathologic response in tumor specimens treated with 42.75 Gy in 15 fractions compared to previously reported rates of hyalinization, fibrosis, or necrosis.

IV. To explore quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G), financial toxicity as measured by the Comprehensive Score for financial Toxicity (COST) Instrument, and patient reported outcomes, as measured by the Toronto Extremity Salvage Score (TESS), among individuals undergoing a shorter, hypofractionated course of pre-operative radiation therapy for soft tissue sarcoma of the extremity or superficial trunk.

V. To gather subjective data on patient treatment preferences and experiences among individuals undergoing a shorter, hypofractionated course of pre-operative radiation therapy for soft tissue sarcoma of the extremity or superficial trunk.

OUTLINE:

Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-4 months for 2 years, every 6 months for 3 years, and then every year for up to 10 years.

Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk

Prospective Trial of Hypofractionated Pre-Operative Radiation Therapy for Localized, Resectable Soft Tissue Sarcoma of the Extremity or Superficial Trunk (HYPORT-STS)

A Bayesian approach for the analysis of a stopping rule of higher acute wound complications for the new dose (E) will be employed.

The data from long-term follow-up will be analyzed for the local recurrence free survival. Kaplan-Meier curves will be generated of survival estimates. We will compare these to historical controls.

The data from long-term follow-up will be analyzed for disease-free survival. Kaplan-Meier curves will be generated of survival estimates. Will compare these to historical controls.

Kaplan-Meier curves will be generated of survival estimates.

Acute toxicity will be documented and rates tabulated.

Late radiation toxicity will be documented and rates tabulated.

Limb function and overall patient quality of life/functional status will be documented according to the Musculoskeletal Tumor Society (MSTS) and Toronto Extremity Salvage Score (TESS) and Euroqol-5D (EQ5D), which will be summarized and analyzed as a continuous variable. Differences between mean scores will be tested using the Mann-Whitney test. Mean and median and their 95% confidence interval (CI) will be presented.

Limb function and overall patient quality of life/functional status will be documented according to the MSTS and TESS and Euroqol-5D (EQ5D), which will be summarized and analyzed as a continuous variable. Differences between mean scores will be tested using the Mann-Whitney test. Mean and median and their 95% CI will be presented.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with CT-chest and imaging of the primary site.

Patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or CXR and imaging of the primary site.

Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.

Chest Radiography

Computed Tomography

Follow-Up

Imaging Technique

Christina L Roland, MD

Christina L. Roland

This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. In cancer survivors, the fear of cancer coming back (recurring) is common and may persist long after the end of treatment. It may also be exacerbated by return visits for imaging (surveillance). The purpose of this study is to determine how patients' anxiety and other cancer-related outcomes are affected by how often surveillance is done.

PRIMARY OBJECTIVE:

I. To evaluate whether a risk-based limited follow-up surveillance is associated with reduced patient anxiety compared to risk-based intense surveillance.

SECONDARY OBJECTIVE:

I. To evaluate the impact of reduced surveillance in low-risk patients on overall survival, time to local or distant recurrence, anxiety at early and late time-points, out of pocket costs, and number of missed or extra clinic visits, compared to the risk-based intense follow-up in both low-risk and high-risk patients.

OUTLINE: Patients are assigned to 1 of 2 groups based on risk status.

GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with computed tomography (CT)-chest and imaging of the primary site.

ARM II: Patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or chest x-ray (CXR) and imaging of the primary site.

GROUP 2 (HIGH RISK): Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.

Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities

Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma

Will be calculated as the area under the curve by obtaining patient-reported outcomes at 4 separate time points and then graphically calculating and comparing the area under the curve for each patient. The mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form will be estimated along with a 95% confidence interval within each study group.

Will be estimated along with a 95% confidence interval within each study group.

Will be assessed by the Fear of Cancer Recurrence Inventory - Short Form via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.

Will be assessed by the Impact of Events scale via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.

Will be assessed by the Hospital Anxiety and Depression Scale via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.

Will be assessed by the Cost Survey via linear mixed models over time and to compare changes of these assessments over time between the two low-risk groups adjusting for important covariates such age, gender and other patient prognostic factors.

Will be estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in survival between groups.

The analysis of number of missed or extra clinic visits will be descriptive in nature.

Nervous System Diseases

Liposarcoma

Histiocytoma, Malignant Fibrous

Fibrosarcoma

Histiocytoma

Histiocytoma, Benign Fibrous

Leiomyosarcoma

Rhabdomyosarcoma

Sarcoma, Synovial

Nerve Sheath Neoplasms

Neurofibrosarcoma

Myosarcoma

Neoplasms, Adipose Tissue

Neoplasms, Connective Tissue

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neoplasms, Fibrous Tissue

Neurofibromatoses

Neurofibroma

Undifferentiated Pleomorphic Sarcoma

Synovial Sarcoma

Malignant Peripheral Nerve Sheath Tumor

Neurofibromatosis

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Nivolumab

Poly I-C

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive BO-112 intratumorally on days 8 and 15 or 1, 8, and 15 and nivolumab IV over 30-60 minutes on day 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy on days 8-12 for a total of 5 fractions. Patients then undergo standard of care definitive surgical resection on day 26 to 50.

Definitive Surgical Resection

Nanoplexed Poly I:C BO-112

Radiation Therapy

Vishruth Reddy, MD, PhD

This phase I trial studies the side effects of BO-112 when given together with nivolumab before surgery in treating patients with soft tissue sarcoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with BO-112, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab and BO-112 before surgery may work better in treating patients with soft tissue sarcoma compared to nivolumab alone.

PRIMARY OBJECTIVE:

I. To determine the safety and tolerability of integrating BO-112, and BO-112 with nivolumab in soft tissue sarcoma patients undergoing preoperative radiotherapy.

SECONDARY OBJECTIVES:

I. Determine the change in T cell infiltration at surgical resection from baseline as measured by immunohistochemistry.

II. Assess treatment effect (necrosis score) of BO-112 and BO-112 in combination with nivolumab in soft tissue sarcoma patients receiving preoperative hypofractionated radiotherapy, compared to patients treated on a recently completed phase 2 study of preoperative hypofractionated radiotherapy alone.

III. Evaluate the 2-year rate of local and distant metastasis of BO-112 and BO-112 in combination with nivolumab in patients with localized resectable soft tissue sarcoma receiving preoperative hypofractionated radiotherapy, as compared to historical patients receiving preoperative radiotherapy alone.

EXPLORATORY OBJECTIVES:

I. Evaluate the dynamics of the intratumoral T cell phenotype. II. Assess the capacity to grow ex vivo tumor infiltrating lymphocytes from patients treated with BO-112 and BO-112 in combination with nivolumab.

III. Analyze changes in T-cell receptor (TCR) repertoire in tumor infiltrating lymphocytes and peripheral blood mononuclear cells (PBMCs) between baseline, post-treatment, and ex vivo cultured tumor infiltrating lymphocyte (TIL) samples.

IV. For patients with disease burden outside of the resected lesion, assess imaging response to treatment using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

OUTLINE:

Patients receive BO-112 intratumorally on days 8 and 15 or 1, 8, and 15 and nivolumab intravenously (IV) over 30-60 minutes on day 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy on days 8-12 for a total of 5 fractions. Patients then undergo standard of care definitive surgical resection on day 26 to 50.

After completion of study treatment, patients are followed up at 2 weeks, 3 months, and between 6-12, 12-18, and 18-24 months.

Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma

A Phase I Study of Nivolumab and Intratumoral BO 112 for Resectable Soft Tissue Sarcoma

AEs will be tabulated by type, severity, and the proportion of subject experiencing the event.

Statistical analysis of immune-oncologic changes will be performed by comparing results from surgical specimens with baseline biopsy specimens. For immunohistochemical parameters, the percentage of CD4+ (cluster of differentiation 4) or CD8+((cluster of differentiation 8) cells will be compared between biopsy and surgical specimens using a paired two-tailed ratio T-test comparing means.

Will be compared to historical samples receiving preoperative radiotherapy alone. Will use a two-sample paired T-test comparing means.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma	NCT03727789	Advanced Cutane... Advanced Sarcom... Clinical Stage ... Clinical Stage ... Pathologic Stag... Pathologic Stag... Pathologic Stag... Recurrent Cutan... Recurrent Sarco... Stage III Soft ... Stage IIIA Soft... Stage IIIB Soft... Stage IV Soft T...	FACT Complex-ta...	18 Years -	Roswell Park Cancer Institute
Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk	NCT03819985	Resectable Soft... Stage I Soft Ti... Stage IA Soft T... Stage IB Soft T... Stage II Soft T... Stage III Soft ... Stage IIIA Soft... Stage IIIB Soft...	Hypofractionate... Quality-of-Life... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities	NCT04751409	Stage II Soft T... Stage III Soft ... Stage IIIA Soft... Stage IIIB Soft...	Chest Radiograp... Computed Tomogr... Follow-Up Follow-Up Imaging Techniq... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma	NCT04420975	Leiomyosarcoma Malignant Perip... Myxofibrosarcom... Pleomorphic Rha... Resectable Dedi... Resectable Soft... Resectable Undi... Soft Tissue Fib... Spindle Cell Sa... Stage I Retrope... Stage I Soft Ti... Stage IA Retrop... Stage IA Soft T... Stage IB Retrop... Stage IB Soft T... Stage II Retrop... Stage II Soft T... Stage III Retro... Stage III Soft ... Stage IIIA Retr... Stage IIIA Soft... Stage IIIB Retr... Stage IIIB Soft... Storiform-Pleom... Synovial Sarcom... Undifferentiate... Undifferentiate... Undifferentiate... Undifferentiate... Undifferentiate...	Definitive Surg... Nanoplexed Poly... Nivolumab Radiation Thera...	18 Years -	Jonsson Comprehensive Cancer Center
CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma	NCT03727789	Advanced Cutane... Advanced Sarcom... Clinical Stage ... Clinical Stage ... Pathologic Stag... Pathologic Stag... Pathologic Stag... Recurrent Cutan... Recurrent Sarco... Stage III Soft ... Stage IIIA Soft... Stage IIIB Soft... Stage IV Soft T...	FACT Complex-ta...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for stage iiib soft tissue sarcoma of the trunk and extremities ajcc v8