Sarcoma And Solid Tumors

Solid tumors are masses that can grow almost anywhere in the body with the exception of the blood (hematological cancer). Solid tumors as split into two categories: sarcomas and carcinomas.

Our research team looks for ways to decrease the size and impact of solid tumors, or to slow the growth of the tumor in the safest way possible. This is determined through a combination of inhibitors, radiation treatments, and other therapies. Our researchers also evaluate tumors through biopsies to better understand what the genetic make-up of the tumor is and how it can be treated.

A Phase 1/2 Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors

Protocol ID: ADVL1711 Diseases: CNS Tumors, Ewing Sarcoma (EWS), High Grade Glioma (HGG), Osteosarcoma (OS), Rhabdomyosarcoma, and Sarcoma Who Can Participate?: Replased/Refractory, ages 2 to 20

Lead Researcher: Mark A. Ranalli, MD

A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination with Azacitidine in Patients with Recurrent, Resectable Osteosarcoma

Protocol ID: MCC19487 Diseases: Osteosarcoma (OS) and Sarcoma Who Can Participate?: Replase/Refractory, ages 0 to 39 Lead Researcher: Bhuvana A. Setty, MD

A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

Protocol ID: ARST1431 Disease: RMS Who can participate?: Must be ≤ 40 yrs w/ newly dx RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification, are eligible to enroll on the study based upon Stage, Group, and age, as defined by the protocol. Lead Researcher: Mark A. Ranalli

A Safety, Pharmacokinetic and Efficacy Study of a Gamma-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors

Protocol ID: ARST1921 Disease: Sarcoma Who Can Participate?: Relapse/Refractory, ages 1 to 17 Lead Researcher: Mark A. Ranalli, MD

ADVL1921, Phase 1 study to evaluate the safety and pharmacokinetics of Palbociclib Ibrance® in combination with Irinotecan and Temozolomide in pediatric patients with recurrent or refractory solid tumors

Protocol ID: ADVL1921 Disease: Solid tumors Who can participate?: Age ≥2 and <21 years at the time of study entry. Histologically confirmed relapsed or refractory solid tumors. Lead Researcher: Mark A. Ranalli

AHEP1531, Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)

Protocol ID: AHEP1531 Disease: Hepatoblastoma Who can participate?: Patients must be ≤ 30 years of age at the time of diagnosis. Patients in Group F must have a BSA ≥ 0.6 m2. Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted in Section 3.2.5 below. Patients with a diagnosis of hepatocellular neoplasm, not otherwise specified,should be classified and treated per hepatoblastoma treatment arms. Lead Researcher: Mark A. Ranalli

ALTE16C1, Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult (AYA) Survivors of Osteosarcoma

Protocol ID: ALTE16C1

Disease: Solid Tumors

Who can participate?: Male patients must be ≥ 18 and ≤ 50 years of age at the time of enrollment.

Lead Researcher: Mark A. Ranalli

APEC1621J, NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of BVD-523FB (ulixertinib) in Patients with Tumors Harboring Activating MAPK Pathway Mutations

Protocol ID: APEC1621J Disease: Solid Tumors Who can participate?: Patients must be ≥ than 12 months and ≤ 21 years of age at the time of study enrollment. Patients must have a body surface area ≥ 0.54 m2 at the time of study enrollment. Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621J based on the presence of an actionable mutation. Lead Researcher: Mark A. Ranalli

AREN03B2, Renal Tumors Classification, Biology and Banking Study

Protocol ID: AREN03B2 Disease: Wilms tumor Who Can Participate?: New diagnosis, ages 0 to 230 Lead Researcher: Mark A. Ranalli, MD

AREN1721, A Randomized Phase 2 Trial of Axitinib/Nivolumab combination therapy vs single agent Axitinib or Nivolumab for the treatment of TFE/Translocation Renal Cell Carcinoma across all age groups

Protocol ID: AREN1721 Disease: Wilms Tumor Who can participate?: Patients must be ≥ 12 months at enrollment. Patients must have a Body Surface Area (BSA) ≥ 0.53 m2. Histologically confirmed unresectable or metastatic translocation morphology renal cell carcinoma diagnosed using WHO-defined criteria. Patients may be newly diagnosed or have received prior cancer therapy. Patients must have measurable disease, documented by clinical, radiographic, or histologic criteria as defined by RECIST v1.1. Lead Researcher: Mark A. Ranalli

Blood based biomarkers for minimal residual disease detection in pediatric sarcomas

Protocol ID: MCC20320 Disease: Sarcoma Who Can Participate?: New diagnosis, ages 0 to 40 Lead Researcher: Bhuvana A. Setty, MD

Evaluation of ctDNA as prognostic biomarker for patients with newly diagnosed localized Ewing sarcoma or osteosarcoma

Protocol ID: ctDNA

Disease: Solid Tumor

Who can participate?: > 12 months of age at time of study enrollment to 50 years of age. Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, localized or regionally disseminated Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue OR Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, non-pelvic, localized or regionally disseminated high-grade osteosarcoma.

Lead Researcher: Bhuvana A. Setty

MATCH-APEC1621I, Phase 2 subprotocol of Palbociclib in Patients with Tumors Harboring Activating Alterations in Cell Cycle Genes

Protocol ID: APEC1621I Disease: Solid tumors Who can participate?: Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621I based on the presence of an actionable mutation as outlined in the protocol. Lead Researcher: Mark A. Ranalli

MATCH - Phase 2 Sub protocol of Olaparib in patients with tumors harboring defects in DNA damage repair genes.

Protocol ID: APEC1621H

Disease: Solid Tumors

Who can participate?: Prior enrollment on APEC1621SC Ages >12 months and < 21 years of age Must have Radiographically measurable disease Enrollment after > 21 days after the last cytotoxic or myelosuppressive chemotherapy.

Lead Researcher: Mark A. Ranalli

NANT 2004-05: NEUROBLASTOMA BIOLOGY STUDY

Protocol ID: NANT2004-05 Disease: Neuroblastoma (NBL) Who Can Participate?: Replase/Refractory, ages 0 to 99 Lead Researcher: Keri A. Streby, MD

Phase 1 Trial of the LSD1 Inhibitor Sp-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing Sarcoma and Select Sarcomas

Protocol ID: SALA-002-EW16 Disease: Desmoplastic small round cell tumor Ewing Sarcoma Who can participate?: Patients aged 12 and up Lead Researcher: Bhuvana Setty

Phase 1 Trial of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon Beta (VSV-IFNβ-NIS) Monotherapy and in Combination with Avelumab, in Patients with Refractory Solid Tumors

Protocol ID: VYR-VSV2-101 Diseases: Colorectal cancer, Neuroendocrine tumor. and Pheochromocytoma Who Can Participate?: Relapse/Refractory, ages 0 to 18 Lead Researcher: Timothy P. Cripe, MD, PhD

Phase 2 Subprotocol of LOXO-292 in Patients with Tumors Harboring RET Gene Alterations

Protocol ID: APEC1621N Diseases: Solid tumors Who Can Participate?: Ages 1 to 21 Lead Researcher: Mark A. Ranalli, MD

MATCH- Phase 2 Subprotocol of Loxo-101 (Larotrectinib) in patients with tumors harboring actionable NTRK Fusions

Protocol ID: APEC1621A Disease: Solid Tumors Who can participate?: Patients must be greater than 12 months of age and less than 21 years of age at the time of study enrollment Lead Researcher: Mark A. Ranalli, MD

MATCH-Phase 2 Subprotocol of JNJ-42756493 (Erdafitinib) in patients with tumors harboring FGFR1/2/3/4 Alterations

Protocol ID: APEC1621B Disease: Solid tumors Who can participate?: Prior enrollment on APEC1621SC screening protocol. Ages > 21 months and <21 years of age. Must have Radiographically measurable disease. > 21 days after last dose of cytotoxic or myelosuppressive chemotherapy.

Lead Researcher: Mark A. Ranalli, MD

MATCH Phase 2 Sub Protocol of LY3023414 in Patients with Solid Tumors

Protocol ID: APEC1621D Disease: Solid Tumors Who can participate?: Ages > 2 - < 19 years Lead Researcher: Mark A. Ranalli, MD

MATCH- Phase 2 Sub Protocol of Ensartinib patients with tumors harboring ALK or ROS1 genomic alterations

Protocol ID: APEC1621F Disease: Solid tumors Who can participate?: No specific age requirement Lead Researcher: Mark A. Ranalli, MD

MATCH- Phase 2 Sub protocol of Vemurafenib in patients with tumors harboring BRAF V600 Mutations

Protocol ID: APEC1621G Disease: Solid tumor Who can participate?: Patients must be < 30 years of age Lead Researcher: Mark A. Ranalli, MD

MATCH- APEC Screening Protocol for Molecular Analysis for Therapy Choice

Protocol ID: APEC1621SC Disease: Solid tumor Who can participate?: Patients must be ≥ 12 months and ≤ 21 years of age at the time of study enrollment. Patients with recurrent or refractory solid tumors, including nonHodgkin lymphomas, histiocytoses (e.g. LCH, JXG, histiocytic sarcoma), and CNS tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or betaHCG. Lead Researcher: Mark A. Ranalli, MD

NCH Solid Tumor Biology Study: Collection and Banking of Fresh Tumor and Serum Specimens for Research Purposes

Protocol ID: NCHB001

Disease: Solid tumors Who can participate?: No specific age requirement

Lead Researcher: Bhuvana A. Setty, MD

Phase II Study of nab-Paclitaxel in Combination with Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults

Protocol ID: MCC18613

Disease: Sarcoma Who can participate?: Patients must be age > 12 and ≤30 years, and have had a histologic diagnosis of osteosarcoma, Ewing sarcoma, or rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma either at diagnosis or relapse. Lead Researcher: Bhuvana A. Setty, MD

Multicenter Cohort Study To Evaluate Outcomes after Receipt of Targeted Therapy Matched to an Individualized Cancer Therapy (iCat) Recommendations in Children and Young Adults with Recurrent, Refractory, or High Risk Solid Tumors: The iCat2, GAIN Consortium Study

Protocol ID: GAIN Disease: Solid tumors Who can participate?: Age ≤ 30 years at time of initial qualifying solid tumor diagnosis.

Lead Researcher: Susan I. Vear, MD

A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects with Advanced Non Central Nervous SystemTumors That are Amenable to Direct Injection

Protocol ID: TVEC Disease: Non-CNS Solid Tumor Who can participate?: Subjects 2 to ≤ 21 years of age. Histologically or cytologically confirmed non-CNS solid tumor that recurred after standard/frontline therapy, or for which there is no standard/frontline therapy available. Lead Researcher: Keri A. Streby, MD