← Back to Search

Monoclonal Antibodies

ADI-PEG 20 + Chemotherapy for Prostate Cancer

Phase 1 & 2

Recruiting

Led By Ana Aparicio, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Male aged 18 years and above

Histologically or cytologically confirmed prostate carcinoma

Must not have

Any unresolved toxicity (CTCAE Grade ≥2) from previous anti-cancer therapy

Active uncontrolled infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a drug combo to see what dose works best to treat advanced prostate cancer.

Who is the study for?

This trial is for men over 18 with aggressive variant prostate cancer (AVPC) that has spread, as shown by scans. They must consent to tissue collection and agree to birth control if their partners can have children. Participants need good organ function, low testosterone levels on treatment, and a performance status score of ≤2. Men who've had more than one chemo or specific drugs for CRPC aren't eligible.

What is being tested?

The study aims to find the safest dose of ADI-PEG20 when used with carboplatin and cabazitaxel in treating AVPC. It's a phase I/II trial which means they're looking at safety, side effects, and early signs of how well it works.

What are the potential side effects?

Possible side effects include reactions related to the immune system due to ADI-PEG20 or pegylated compounds, blood disorders from chemotherapy agents like carboplatin and cabazitaxel, fatigue, digestive issues such as nausea or diarrhea, increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a man aged 18 or older.

Select...

My prostate cancer has been confirmed by a lab test.

Select...

My cancer has spread to other parts of my body, confirmed by scans.

Select...

I have undergone treatment to lower my testosterone levels below 50 ng/dL.

Select...

I can perform daily activities with minimal assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I don't have lasting side effects from cancer treatment above mild.

Select...

I currently have an infection that isn't under control.

Select...

I have had lung inflammation or widespread lung disease not caused by cancer.

Select...

I have been treated for prostate cancer with carboplatin, cisplatin, or cabazitaxel.

Select...

I have active hepatitis or chronic liver disease.

Select...

I have another cancer with a high chance of coming back within 2 years.

Select...

I have undergone more than one chemotherapy treatment. I may have had hormone or targeted therapies.

Select...

I have recovered from major side effects of my prostate cancer treatment.

Select...

I have brain metastases or spinal cord compression that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Dose Escalation and Monotherapy MaintenanceExperimental Treatment3 Interventions

Participants will be assigned to a study group and dose level of ADI-PEG20 based on when participant join this study. Up to 2 dose levels of ADI-PEG20 may be tested. Up to 15 participants will be enrolled per dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Cabazitaxel

2014

Completed Phase 3

~1290