Treatment (monoclonal antibody therapy) for Cancer

Phase 1

Waitlist Available

Led By Suman Malempati

Research Sponsored by National Cancer Institute (NCI)

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 30 days after completion of treatment

Awards & highlights

No Placebo-Only Group

Summary

This phase I clinical trial is studying the side effects and best dose of IMC-A12 in treating young patients with relapsed or refractory Ewing sarcoma/peripheral primitive neuroectodermal tumor or other solid tumors. Monoclonal antibodies, such as IMC-A12, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

Eligible Conditions

Cancer
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly during each course

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly during each course

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly during each course for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0

MTD or recommended phase II dose

Secondary study objectives

Response rate (complete or partial response) in patients with Ewing sarcoma/peripheral PNET

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 (monoclonal antibody therapy)Experimental Treatment3 Interventions

Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 4 weeks for up to 2 years in the absence of unacceptable toxicity or disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cixutumumab

Not yet FDA approved

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