Trial record 11 of 13 for: 22186789 [PUBMED-IDS] AND intradermal

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Vigil + Irinotecan and Temozolomide in Ewing's Sarcoma (VITA)

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ClinicalTrials.gov Identifier: NCT03495921

Recruitment Status : Recruiting

First Posted : April 12, 2018

Last Update Posted : November 18, 2019

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Sponsor:

Information provided by (Responsible Party):

Gradalis, Inc.

Study Description

Brief Summary:

This is a multicenter, 1:1 randomized Phase III study of intradermal autologous Vigil immunotherapy (1.0 x 10e6 cells/injection; minimum of 4 to a maximum of 12 administrations) in combination with irinotecan and temozolomide in subjects with metastatic Ewing's sarcoma Family of Tumors (ESFT) refractory/intolerant or recurrent to 1 prior line of chemotherapy. Participants undergoing a standard surgical procedure (e.g., tumor biopsy or palliative resection) may have tumor tissue harvested for manufacture of the investigational product, Vigil.

Condition or disease	Intervention/treatment	Phase
Ewing Sarcoma Ewing Family of Tumors Ewing's Tumor Metastatic Ewing's Sarcoma Metastatic Ewing's Tumor Recurrent Rare Diseases Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Sarcoma, Ewing Neoplasms	Biological: Vigil Drug: Irinotecan Drug: Temozolomide	Phase 3

Detailed Description:

Participants will be managed in an outpatient setting. Hematologic function, liver enzymes, renal function and electrolytes will be monitored. Blood for immune function analyses including IFNγ-ELISPOT analysis of cytotoxic T cell activation in response to autologous tumor antigens will be collected at tissue procurement, post-procurement screening and Day 1 (prior to chemotherapy administration) at Cycles 2, 4, and 6, end of treatment (EOT), 3 months after EOT, and every 6 months thereafter. Blood for ctDNA analysis will be collected at tissue procurement, prior to chemotherapy administration at baseline and on Day 1 prior to chemotherapy administration at Cycles 2, 3, 4, and 6, and EOT.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	114 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Group A (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) oral irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), and (iii) Vigil 1.0 x 10e6 cells/injection cells/injection, intradermally on Day 15. or Group B (i) (oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), and (ii) oral irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle).
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Multi-Center Phase III, Randomized, Open-Label Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Combination With Irinotecan and Temozolomide as a Second-Line Regimen for Ewing's Sarcoma
Actual Study Start Date :	August 21, 2018
Estimated Primary Completion Date :	December 31, 2021
Estimated Study Completion Date :	July 1, 2022

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Ewing sarcoma

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Modafinil Temozolomide Irinotecan Irinotecan hydrochloride Armodafinil

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Ewing Sarcoma Osteosarcoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vigil + Irinotecan and Temozolomide Group A Schedule: Temozolomide 100 mg/m2 daily, oral, Days 1 - 5, every 21 days Irinotecan 50 mg/m2 daily, oral, Days 1 - 5, every 21 days Vigil 1.0 x 10e6 cells/injection, intradermal, Day 15, every 21 days for a minimum of 4 administrations to a maximum of 12 administrations depending on quantity of Vigil manufactured from surgical specimens and so long as the patient is clinically stable and without disease progression. Subjects may receive repeat cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.	Biological: Vigil Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms. Other Names: Engineered Autologous Tumor Cell Immunotherapy FANG IND14205 Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy Drug: Irinotecan Irinotecan injectable formulation will be obtained. This will be drawn up into oral syringes (1 cycle of 5 doses) and dispensed to the subject with instructions to refrigerate until administration. Irinotecan may be mixed with cranberry-grape juice immediately before administration to mask the bitter flavor and administered once daily on Days 1 through 5 of each 3-week cycle. Other Names: Camptosar Camptothecin-11 CPT-11 Drug: Temozolomide Temozolomide capsules may be opened and mixed in apple sauce or juice if unable to swallow whole capsules. Temozolomide is administered on Days 1 through 5 of each 3-week course and given at least 1 hour before Irinotecan. Other Name: Temodar
Active Comparator: Irinotecan and Temozolomide Group B Schedule: Temozolomide 100 mg/m2 daily, oral, Days 1 - 5, every 21 days Irinotecan 50 mg/m2 daily, oral, Days 1 - 5, every 21 days Subjects may receive repeat cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study. Within 6 weeks of second relapse or progression, subjects randomized to Group B, will be allowed to cross-over to receive single agent Vigil every 21 days following End of Treatment assessments. Subjects who cross-over may receive up to 12 doses of Vigil depending upon the quantity of Vigil manufactured. Cross-over must occur within 2 years of End of Treatment assessments of Group B enrollment.	Drug: Irinotecan Irinotecan injectable formulation will be obtained. This will be drawn up into oral syringes (1 cycle of 5 doses) and dispensed to the subject with instructions to refrigerate until administration. Irinotecan may be mixed with cranberry-grape juice immediately before administration to mask the bitter flavor and administered once daily on Days 1 through 5 of each 3-week cycle. Other Names: Camptosar Camptothecin-11 CPT-11 Drug: Temozolomide Temozolomide capsules may be opened and mixed in apple sauce or juice if unable to swallow whole capsules. Temozolomide is administered on Days 1 through 5 of each 3-week course and given at least 1 hour before Irinotecan. Other Name: Temodar

Arm

Intervention/treatment

Experimental: Vigil + Irinotecan and Temozolomide

Group A Schedule:

Temozolomide 100 mg/m2 daily, oral, Days 1 - 5, every 21 days Irinotecan 50 mg/m2 daily, oral, Days 1 - 5, every 21 days Vigil 1.0 x 10e6 cells/injection, intradermal, Day 15, every 21 days for a minimum of 4 administrations to a maximum of 12 administrations depending on quantity of Vigil manufactured from surgical specimens and so long as the patient is clinically stable and without disease progression.

Subjects may receive repeat cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.

Biological: Vigil

Vigil is composed of autologous tumor cells harvested from the patient at the time of initial de-bulking surgery which are then transfected extracorporeally, with a plasmid encoding for the gene for GM-CSF, an immune-stimulatory cytokine, and a bifunctional, short hairpin RNA which specifically knocks down the expression of furin, the critical convertase responsible for production of the two TGβ isoforms.

Other Names:

Engineered Autologous Tumor Cell Immunotherapy
FANG
IND14205
Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy

Drug: Irinotecan

Irinotecan injectable formulation will be obtained. This will be drawn up into oral syringes (1 cycle of 5 doses) and dispensed to the subject with instructions to refrigerate until administration. Irinotecan may be mixed with cranberry-grape juice immediately before administration to mask the bitter flavor and administered once daily on Days 1 through 5 of each 3-week cycle.

Other Names:

Camptosar
Camptothecin-11
CPT-11

Drug: Temozolomide

Temozolomide capsules may be opened and mixed in apple sauce or juice if unable to swallow whole capsules. Temozolomide is administered on Days 1 through 5 of each 3-week course and given at least 1 hour before Irinotecan.

Other Name: Temodar

Active Comparator: Irinotecan and Temozolomide

Group B Schedule:

Temozolomide 100 mg/m2 daily, oral, Days 1 - 5, every 21 days Irinotecan 50 mg/m2 daily, oral, Days 1 - 5, every 21 days

Subjects may receive repeat cycles of treatment until disease progression, unacceptable toxicity, withdrawal of consent or other criterion is met for discontinuation from study.

Within 6 weeks of second relapse or progression, subjects randomized to Group B, will be allowed to cross-over to receive single agent Vigil every 21 days following End of Treatment assessments. Subjects who cross-over may receive up to 12 doses of Vigil depending upon the quantity of Vigil manufactured. Cross-over must occur within 2 years of End of Treatment assessments of Group B enrollment.

Drug: Irinotecan

Other Names:

Camptosar
Camptothecin-11
CPT-11

Drug: Temozolomide

Other Name: Temodar

Outcome Measures

Primary Outcome Measures :

Progression Free Survival (PFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ]
Progression Free Survival (PFS) is defined as the time from randomization to the event of disease recurrence/progression or death due to any cause. PFS of subjects dosed with Vigil immunotherapy in combination with irinotecan and temozolomide vs. irinotecan and temozolomide will be compared.

Secondary Outcome Measures :

Overall Survival (OS) [ Time Frame: From date of randomization until date of death from any cause, whichever came first, assessed up to 5 years ]
OS is defined as time from randomization to death or to the date of last follow-up. The date of last follow-up confirming survival will be used as the censoring date for subjects who are alive and/or do not have a known date of death. OS of subjects with relapsed or refractory Ewing's sarcoma dosed with Vigil immunotherapy in combination with irinotecan and temozolomide will be determined and compared.
Radiological Tumor Assessment [ Time Frame: Through study completion and then follow up, approximately 2 years ]
The objective response rate (RECIST 1.1) of patients with metastatic Ewing's sarcoma refractory or intolerant to 1 prior line of systemic chemotherapy treated with Vigil immunotherapy dosed with Vigil immunotherapy in combination with irinotecan and temozolomide will be compared.
Vigil Manufacturing Success Rate [ Time Frame: From manufacturing start date until 4 weeks post manufacturing for each tissue procurement. ]
Vigil Manufacturing Success Rate will be defined as passing cell number, cell viability, efficacy, and purity tests.

Eligibility Criteria

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Ages Eligible for Study:	2 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Tissue Procurement Inclusion Criteria:

Histologically confirmed Ewing's Sarcoma Family of Tumors (ESFT).
Age ≥ 2 years.
Estimated survival ≥ 6 months.
Evidence of EWS translocation by FISH or RT-PCR or Next Generation Sequencing (NGS). If available, NGS sequencing report should be submitted to Gradalis.
Recurrence or refractory to 1 line of systemic chemotherapy, including but not limited to doxorubicin, vincristine, and ifosfamide.
Planned standard of care surgical procedure (e.g., tumor biopsy or palliative resection or thoracentesis) and expected availability of a cumulative soft-tissue mass of ~10-30 grams tissue ("grape" to "golf-ball" size / approximately 2 cm total diameter on imaging) or pleural fluid estimated volume ≥ 500mL (from a primary or secondary thoracentesis, yielding in a high volume of tumor cells) for immunotherapy manufacture.
Tumor intended for immunotherapy manufacture is not embedded in bone and does not contain luminal tissue (e.g. bowel, ureter, bile duct).
Ability to understand and the willingness to sign a written protocol specific informed consent for tissue harvest or a parental/guardian informed consent and pediatric assent when appropriate.

Tissue Procurement Exclusion Criteria:

Medical condition requiring any form of chronic systemic immunosuppressive therapy (steroid or other) except physiologic replacement doses of hydrocortisone or equivalent (no more than 30 mg hydrocortisone or 10 mg prednisone equivalent daily) for < 30 days duration.
Known history of other malignancy unless having undergone curative intent therapy without evidence of that disease for ≥ 3 years except cutaneous squamous cell and basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other in situ cancers are allowed if definitively resected.
Brain metastases unless treated with curative intent (gamma knife or surgical resection) and without evidence of progression for ≥ 2 months.
Any documented history of autoimmune disease with exception of Type 1 diabetes on stable insulin regimen, hypothyroidism on stable dose of replacement thyroid medication, vitiligo, or asthma not requiring systemic steroids.
Known HIV or chronic Hepatitis B or C infection.
Known hypersensitivity to any temozolomide component or to dacarbazine (DTIC).
Known hypersensitivity to irinotecan or its excipients.
Known history of allergies or sensitivities to gentamicin.
History of or current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.

Study Enrollment Inclusion Criteria:

Completed manufacture of at least 4 vials of Vigil.
Karnofsky performance status (KPS) / Lansky performance status (LS) ≥80%.
Normal organ and marrow function as defined below:

Absolute granulocyte count ≥1,000/mm3, Absolute lymphocyte count ≥400/mm3, Platelets ≥75,000/mm3, Hemoglobin ≥ 8.0 mg/dL, Total bilirubin ≤ institutional upper limit of normal*, AST(SGOT)/ALT(SGPT) ≤2x institutional upper limit of normal, Creatinine <1.5 mg/dL

* documented Gilbert's syndrome may be considered after medical monitor review
Subject has recovered to CTCAE Grade 1 (except for parameters noted in Item 3, above) or better from all adverse events associated with prior therapy or surgery. Pre-existing motor or sensory neurologic pathology or symptoms, or dermatologic must be recovered to CTCAE Grade 2 or better.
If female of childbearing potential, has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a negative serum test will be required for study entry.
Ability to understand and the willingness to sign a written informed protocol specific consent or a parental/guardian informed consent and pediatric assent when appropriate.

Study Enrollment Exclusion Criteria:

In addition to the procurement exclusion criteria, subjects will NOT be eligible for study registration and randomization if meeting any of the following additional criteria:

Any anti-neoplastic therapy between tissue procurement for Vigil manufacture and start of study therapy.
Live vaccine used for the prevention of infectious disease administered < 30 days prior to the start of study therapy.
Post-surgery complication that in the opinion of the treating investigator would interfere with the patient's study participation or make it not in the best interest of the patient to participate.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495921

Contacts

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Contact: Gladice Wallraven	214-442-8124	info@gradalisinc.com

Locations

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United States, Arkansas
Arkansas Children's Hospital	Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Catherine Redinger, RN 501-364-4290 RedingerCatherineL@uams.edu
United States, California
Southern California Permanente Medical Group	Recruiting
Los Angeles, California, United States, 90027
Contact: Olga Ducker, MBA, CCRP 626-344-4547 Olga.E.Ducker@kp.org
UCLA Children's Health Center	Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Rubi Arias 310-794-0345 rubiarias@mednet.ucla.edu
Contact: Marianne Bernardo 310-794-8086 mjbernardo@mednet.ucla.edu
Stanford Children's Health	Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Nancy K Sweeters, RN, PNP 650-721-4074 nancy.sweeters@stanford.edu
Contact: Shivani Reddy, CRCA (650)723-5535 shivanir@stanford.edu
United States, Florida
Mayo Clinic Florida	Recruiting
Jacksonville, Florida, United States, 32224
Contact: Steven Attia, DO 904-953-7292 Attia.Steven@mayo.edu
Nicklaus Children's Hospital	Recruiting
Miami, Florida, United States, 33155
Contact: Fabian Castillo 786-624-2824 Fabian.Castillo@nicklaushealth.org
Contact: Matthew Bittle Matthew.Bittle@Nicklaushealth.org
United States, Massachusetts
Dana-Farber/Boston Children's Cancer and Blood Disorders	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Steven DuBois, MD 617-632-5460 Steven_Dubois@dfci.harvard.edu
United States, Missouri
Washington University Siteman Cancer Center	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Michele Landeau 314-747-9488 landeaum@wustl.edu
United States, Nebraska
Nebraska Methodist Hospital	Recruiting
Omaha, Nebraska, United States, 68114
Contact: Kacey Coenen, BSN,RN,OCN 402-354-5129 kacey.coenen@nmhs.org
United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Morgan Coleman colemanm@mskcc.org
Contact: Leonard H. Wexler, MD 212-639-7990
Principal Investigator: Leonard H. Wexler, MD
United States, North Carolina
Duke Children's Hospital and Health Center; Duke Cancer Institute	Recruiting
Durham, North Carolina, United States, 27710
Contact: Jessica Pennell jessica.pennell@duke.edu
Contact: Lars Wagner lars.wagner@duke.edu
United States, Ohio
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229
Contact 513-636-2799 cancer@cchmc.org
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Peter Anderson, MD 216-445-4044 andersp@ccf.org
Contact: Stacey Zahler, MD 216-445-3588 zahlers@ccf.org
United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Margaret von Mehren, MD 215-728-2814 Margaret.vonMehren@fccc.edu
United States, Texas
Texas Oncology - Pediatrics	Recruiting
Dallas, Texas, United States, 75230
Contact: Maurizio Ghisoli, MD 972-566-6647 Maurizio.Ghisoli@usoncology.com
Cook Children's Medical Center	Recruiting
Fort Worth, Texas, United States, 76104
Contact: Lauren Bird, RN 682-885-4874 Lauren.Bird@cookchildrens.org
Contact: Lucy Marmolejo (682) 885-8088 Lucy.marmolejo@cookchildrens.org
United States, Washington
Seattle Cancer Care Alliance	Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Roxanne Moore 206-606-6425 romoore@seattlecca.org

Sponsors and Collaborators

Gradalis, Inc.

Investigators

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Study Director:	Luisa Manning, MD	Gradalis, Inc.

More Information

Additional Information:

Long Term Follow Up: Phase I Trial of "bi-shRNA furin/GMCSF DNA/ Autologous Tumor Cell" Immunotherapy (FANG™) in Advanced Cancer This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Case Report: Vigil Therapy in Pathology Defined High-Risk Differentiated Thyroid Cancer Compounded by Post Ablation High-Risk Factors This link exits the ClinicalTrials.gov site

Assessment of Low Dose Vigil® Engineered Autologous Tumor Cell (EATC) Immunotherapy in Patients with Advanced Solid Tumors This link exits the ClinicalTrials.gov site

Publications:

Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.

Nemunaitis J, Barve M, Orr D, Kuhn J, Magee M, Lamont J, Bedell C, Wallraven G, Pappen BO, Roth A, Horvath S, Nemunaitis D, Kumar P, Maples PB, Senzer N. Summary of bi-shRNA/GM-CSF augmented autologous tumor cell immunotherapy (FANG™) in advanced cancer of the liver. Oncology. 2014;87(1):21-9. doi: 10.1159/000360993. Epub 2014 Jun 25.

Ghisoli M, Barve M, Mennel R, Lenarsky C, Horvath S, Wallraven G, Pappen BO, Whiting S, Rao D, Senzer N, Nemunaitis J. Three-year Follow up of GMCSF/bi-shRNA(furin) DNA-transfected Autologous Tumor Immunotherapy (Vigil) in Metastatic Advanced Ewing's Sarcoma. Mol Ther. 2016 Aug;24(8):1478-83. doi: 10.1038/mt.2016.86. Epub 2016 Apr 25.

Ghisoli M, Barve M, Schneider R, Mennel R, Lenarsky C, Wallraven G, Pappen BO, LaNoue J, Kumar P, Nemunaitis D, Roth A, Nemunaitis J, Whiting S, Senzer N, Fletcher FA, Nemunaitis J. Pilot Trial of FANG Immunotherapy in Ewing's Sarcoma. Mol Ther. 2015 Jun;23(6):1103-1109. doi: 10.1038/mt.2015.43. Epub 2015 Mar 19.

Ghisoli M, Rutledge M, Stephens PJ, Mennel R, Barve M, Manley M, Oliai BR, Murphy KM, Manning L, Gutierrez B, Rangadass P, Walker A, Wang Z, Rao D, Adams N, Wallraven G, Senzer N, Nemunaitis J. Case Report: Immune-mediated Complete Response in a Patient With Recurrent Advanced Ewing Sarcoma (EWS) After Vigil Immunotherapy. J Pediatr Hematol Oncol. 2017 May;39(4):e183-e186. doi: 10.1097/MPH.0000000000000822.

Oh J, Barve M, Matthews CM, Koon EC, Heffernan TP, Fine B, Grosen E, Bergman MK, Fleming EL, DeMars LR, West L, Spitz DL, Goodman H, Hancock KC, Wallraven G, Kumar P, Bognar E, Manning L, Pappen BO, Adams N, Senzer N, Nemunaitis J. Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer. Gynecol Oncol. 2016 Dec;143(3):504-510. doi: 10.1016/j.ygyno.2016.09.018. Epub 2016 Sep 24.

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Responsible Party:	Gradalis, Inc.
ClinicalTrials.gov Identifier:	NCT03495921 History of Changes
Other Study ID Numbers:	CL-PTL-130
First Posted:	April 12, 2018 Key Record Dates
Last Update Posted:	November 18, 2019
Last Verified:	November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	Yes

Keywords provided by Gradalis, Inc.:


ESFT Immunotherapy Phase 3 irinotecan temozolomide First Relapse Second Line Vigil	vaccine orphan drug soft bone pediatric FLI EWS Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

Additional relevant MeSH terms:

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Sarcoma Sarcoma, Ewing Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Bone Tissue Bone Neoplasms Neoplasms, Connective Tissue Rare Diseases Neoplasms Osteosarcoma Disease Attributes Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases	Connective Tissue Diseases Irinotecan Temozolomide Modafinil Immunologic Factors Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents Central Nervous System Stimulants Wakefulness-Promoting Agents

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