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Monoclonal Antibodies

Pepinemab for Solid Tumors in Young Patients

Phase 1 & 2

Waitlist Available

Led By Emily G Greengard

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

Part B: Patients with recurrent or refractory osteosarcoma with histologic verification of malignancy at original diagnosis or relapse

Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a new immunotherapy drug to treat solid tumors in young patients. The drug may help the body's immune system attack the cancer.

Who is the study for?

This trial is for young patients with solid tumors that have returned or are not responding to treatment, excluding brain tumors. Eligible participants must have a confirmed diagnosis and either measurable or evaluable disease. They should be recovered from previous cancer treatments, meet specific blood count criteria, and not have had certain therapies within specified time frames before joining the trial.Check my eligibility

What is being tested?

The study is testing pepinemab's safety and effectiveness in treating these cancers. Pepinemab is an immunotherapy drug designed to help the immune system fight cancer by stopping tumor cells from growing and spreading. The trial includes laboratory biomarker analysis and pharmacological studies to determine the best dose of pepinemab.See study design

What are the potential side effects?

Possible side effects of pepinemab may include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions such as fever or chills during administration, fatigue, changes in liver function tests, allergic responses, and potential interference with growth in younger patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My osteosarcoma has come back or didn't respond to treatment, confirmed by tests.

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My condition has no cure or treatments that would extend life with good quality.

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I can do most activities myself, even if I use a wheelchair.

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My bilirubin levels are within the normal range for my age.

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I have a recurring or hard-to-treat tumor outside the brain, confirmed by tests.

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I do not have trouble breathing at rest or during exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under Curve (AUC)

Clearance

Disease Control Rate (Part A)

+6 more

Secondary outcome measures

Immunogenicity of Pepinemab

T-lymphocyte Saturation

Total Soluble SEMA4D

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pepinemab)Experimental Treatment3 Interventions

Patients receive pepinemab IV over 60 minutes on days 1 and 15. Treatment repeats every 28 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,674 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,127 Total Patients Enrolled

Emily G GreengardPrincipal InvestigatorCOG Phase I Consortium

Media Library

Pepinemab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03320330 — Phase 1 & 2

Solid Tumors Research Study Groups: Treatment (pepinemab)

Solid Tumors Clinical Trial 2023: Pepinemab Highlights & Side Effects. Trial Name: NCT03320330 — Phase 1 & 2

Pepinemab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03320330 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different locations are participating in this research project?

"Children's Hospital of Alabama in Birmingham, Alabama; Children's Hospital Los Angeles in Los Angeles, California; and Children's Hospital of Orange County in Orange, Colorado are a few examples of the 24 other locations where this trial is enrolling patients."

Answered by AI

Are there any available spots for patients who want to enroll in this clinical trial?

"Unfortunately, this particular clinical trial is not seeking new participants at the moment. The study was originally posted on December 1st, 2018 but has not been updated since April 22nd, 2022. Although this specific trial isn't enrolling patients, there are 3493 other trials that are currently recruiting."

Answered by AI

Does this experiment test the effects of the medication on elderly patients?

"This particular clinical trial is only recruiting patients that are aged between 12 months and 30 years old. Out of the 489 ongoing medical studies for people under 18, this one falls in 3176 trials currently underway for individuals over 65."

Answered by AI

Are there specific requirements for subjects of this research?

"Eligible participants for this clinical study must have cancer and be between 12 months old up to 30 years old. There are approximately 26 spots available."

Answered by AI

What is the clinical evidence to support this medication's use?

"There are six different clinical trials underway that focus on Pharmacological Study. Out of these, none have progressed to Phase 3. A notable number of the total 61 trial sites for Pharmacological Study are based in Louisville, Kentucky."

Answered by AI

What is the goal of this clinical trial?

"The purpose of this study, as measured over a 3 year period, is to Response (Complete Response or Partial Response) (Part B). Additionally, investigators will assess secondary outcomes including Immunogenicity of Pepinemab, T-lymphocyte saturation, and immunogenicity of pepinemab."

Answered by AI

Recent research and studies

Expert Opinion on Emerging DrugsJournal

An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?

Hattinger, Claudia Maria, Maria Pia Patrizio, Federica Magagnoli, Silvia Luppi, and Massimo Serra. 2019. “An Update on Emerging Drugs in Osteosarcoma: Towards Tailored Therapies?”. Expert Opinion on Emerging Drugs. Informa UK Limited. doi:10.1080/14728214.2019.1654455.

clinicaltrials.govStudy

Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors

2018. "Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03320330.

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