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Monoclonal Antibodies
Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma
Phase 2
Waitlist Available
Led By James I Geller
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months (17 courses)
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how well lorvotuzumab mertansine works in treating younger patients with Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma, malignant peripheral nerve sheath tumor (MPNST), or synovial sarcoma that has returned or that does not respond to treatment.
Eligible Conditions
- Wilms Tumor
- Cancer
- Pleuropulmonary Blastoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months (17 courses)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months (17 courses)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1
Other study objectives
CD56 Expression
Pharmacokinetic (PK) Parameters of Lorvotuzumab Mertansine
Side effects data
From 2021 Phase 2 trial • 62 Patients • NCT024525548%
Tooth infection
8%
Hyperkalemia
8%
Dental caries
8%
Alanine aminotransferase increased
8%
Anemia
8%
Catheter related infection
8%
Hyperglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stratum 3: Neuroblastoma
Stratum 4: Pleuropulmonary Blastoma
Stratum 5: Malignant Peripheral Nerve Sheath Tumor
Stratum 6: Synovial Sarcoma
Stratum 2: Rhabdomyosarcoma
Stratum 1: Wims Tumor
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (lorvotuzumab mertansine)Experimental Treatment3 Interventions
Patients receive lorvotuzumab mertansine IV over 1-1.5 hours on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorvotuzumab Mertansine
2015
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
239,936 Total Patients Enrolled
30 Trials studying Wilms Tumor
19,572 Patients Enrolled for Wilms Tumor
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,518 Total Patients Enrolled
54 Trials studying Wilms Tumor
21,258 Patients Enrolled for Wilms Tumor
James I GellerPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
236 Total Patients Enrolled
1 Trials studying Wilms Tumor
221 Patients Enrolled for Wilms Tumor