← Back to Search

Immunomodulator

Copaxone Injections for Cancer

Phase 1

Waitlist Available

Led By Joaquina Baranda, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior therapy for this malignancy.

Men of child-bearing potential must not father a child or donate sperm while on this study until the end of study treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks

Awards & highlights

Study Summary

This trial is testing whether or not injecting Copaxone into tumors will help participants' immune system fight cancer, which has been studied in mice and has shown encouraging results.

Who is the study for?

Eligible participants include men and women with a confirmed diagnosis of squamous cell cancer or basal cell carcinoma, who have not undergone prior treatment for these conditions. They must have tumors at least 5 mm in size that can be injected and agree to use two forms of contraception if of child-bearing potential. Excluded are those pregnant, breastfeeding, hypersensitive to Copaxone®, on immunosuppressive therapy, or with AIDS.Check my eligibility

What is being tested?

This trial is testing the effects of directly injecting Copaxone® into accessible tumors measuring at least the size of a pea. The goal is to stimulate an immune response against the cancer cells. Participants' tissue samples before and after surgery will be compared to assess immune activity and anti-tumor effects.See study design

What are the potential side effects?

Copaxone® is generally considered safe with few side effects as it's already used for treating Multiple Sclerosis (MS). However, participants will be monitored closely for any adverse reactions during the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have not received any treatment for my cancer.

Select...

I agree not to father a child or donate sperm during the study.

Select...

I have been diagnosed with a type of skin cancer.

Select...

I agree to use two forms of birth control or practice abstinence during the study.

Select...

I have a tumor that is at least 5 mm big.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of participants that experience Treatment Related Adverse Events (TRAEs) or Treatment Related Serious Adverse Events (TRSAEs)

Secondary outcome measures

Immune Biomarker Level

Side effects data

From 2007 Phase 4 trial • 75 Patients • NCT00176592

Pregnancy

Pain

Pain/Burning at Injection Site

Loss of Hearing

Gastroenteritis

Pancreatitis

Aneurysm

100%

80%

60%

40%

20%

Study treatment Arm

Betaseron

Copaxone

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intratumoral CopaxoneExperimental Treatment1 Intervention

Eligible subjects receive at least 1 and up to 3 doses of Copaxone® 40 milligrams (mg) intratumorally prior to standard of care surgery. The doses will be administered at least 48 hours apart. The last dose will be given within 96 hours of standard of care surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Copaxone

2007

Completed Phase 4

~2570

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor

462 Previous Clinical Trials

169,197 Total Patients Enrolled

Joaquina Baranda, MDPrincipal InvestigatorThe University of Kansas Cancer Center

2 Previous Clinical Trials

70 Total Patients Enrolled

Media Library

Copaxone (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT03982212 — Phase 1

Squamous Cell Carcinoma Research Study Groups: Intratumoral Copaxone

Squamous Cell Carcinoma Clinical Trial 2023: Copaxone Highlights & Side Effects. Trial Name: NCT03982212 — Phase 1

Copaxone (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03982212 — Phase 1

Frequently Asked Questions

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

What is the participant capacity for this research trial?

"Indeed, clinicaltrials.gov attests that this medical experiment is now recruiting participants and was first advertised on July 26th 2019. Data suggests that 10 individuals are necessary for completion from 3 distinct sites."

Answered by AI

Are there any potential risks associated with Copaxone administration?

"As this is an early phase trial, our team at Power has assigned Copaxone a score of 1 for safety due to the limited amount of evidence available."

Answered by AI

Are there any openings for enrollment in this research?

"Affirmative. According to clinicaltrials.gov, this experiment has commenced recruitment and is actively seeking participants since its initial listing on July 26th 2019. Currently, it requires 10 subjects across 3 sites for completion of the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors

2019. "A Window of Opportunity Trial of Intratumoral Injection of Copaxone® in Patients With Percutaneously Accessible Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03982212.

All > Copaxone