Phase 1 Dose-escalating Study of MM-398 (Irinotecan Sucrosofate Liposome Injection) Plus Intravenous Cyclophosphamide in Recurrent or Refractory Pediatric Solid Tumors

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
South Plains Oncology Consortium
Study ID
NCT02013336
Phase
PHASE1
Status
Unknown

Conditions

  • Ewing Sarcoma
  • Neuroblastoma
  • Osteosarcoma
  • Recurrent or Refractory Solid Tumors
  • Rhabdomyosarcoma

Eligibility Criteria

Sex
ALL
Age
12 Months - 20 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase 1 study of the combination of two drugs: MM-398 and Cyclophosphamide. The goal is to find the highest dose of MM-398 that can be given safely when it is used together with the chemotherapy drug Cyclophosphamide.

Key Dates

Start date
Dec 31, 2013
Status verified
Mar 2022
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MM-398 + cyclophosphamide
    MM-398+cyclophosphamide

Primary Outcome Measure

To determine the Maximum Tolerated Dose (MTD) of MM-398 in combination with intravenous cyclophosphamide by assessing the occurrence of dose limiting toxicities [ Time Frame: 12 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
513-636-4200
Joseph Pressey, MD (PRINCIPAL_INVESTIGATOR)
University Of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Haley Jones
UT SouthwesternDallasTexas75235
Alison Patterson
MD Anderson Children's Cancer HospitalHoustonTexas77030
Jonathan Gill, MD
Texas Tech University Health Sciences CenterLubbockTexas79430
Angie Cervantez
Midwest Children's HospitalMilwaukeeWisconsin53226
Olivia Tarnowske

Find similar trials in Cincinnati, OH

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OHUniversity Of Oklahoma Health Sciences Center· Oklahoma City, OKUT Southwestern· Dallas, TXMD Anderson Children's Cancer Hospital· Houston, TXTexas Tech University Health Sciences Center· Lubbock, TXMidwest Children's Hospital· Milwaukee, WI

Related Studies