RecruitingPhase 1/2

Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC)

United States30 participantsStarted 2024-02-29

Plain-language summary

To find the best dose of ADI-PEG20 that can be given in combination with carboplatin and cabazitaxel to patients with AVPC.

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Completion of informed consent prior to any study specific procedures.
✓. Patients must agree to tissue collection for correlative studies at the specified timepoints.
✓. Patients must consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291.
✓. Male aged 18 years and above.
✓. Histologically or cytologically confirmed prostate carcinoma.
✓. Presence of metastatic disease documented on imaging studies (bone scan, CT and/or MRI scans).
✓. Patients must meet at least one of the following AVPC criteria:
✓. Patients must have documented evidence of progressive disease as defined by any of the following:

✕. Any prior treatment for CRPC with carboplatin, cisplatin or cabazitaxel.
✕. Patients who have received more than one line of chemotherapy for prostate cancer. Any number of prior hormonal or targeted therapies are allowed.
✕. Patients who have not recovered from adverse events secondary to systemic therapy (except for LHRH agonist or antagonist treatment for prostate cancer, and bisphosphonates or RANK ligand inhibitors for bone strengthening), major surgery or radiotherapy for the treatment of prostate cancer to a grade \</= 2.
✕. Any unresolved toxicity (CTCAE Grade ≥2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
✕. Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be allowed on study after discussion with the PI; the PI will serve as the final arbiter regarding eligibility).
✕. Active or symptomatic viral hepatitis or chronic liver disease.
✕. A history of extensive bilateral lung disease of non-malignant etiology.
✕. A malignancy \[other than the one treated in this study\] which has a '≥ 30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix or Ta urothelial carcinomas).

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Timeframe: Through study completion; an average of 1 year.

NCT IDNCT06085729

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-02

Ana Aparicio, MD

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Completion of informed consent prior to any study specific procedures.
✓. Patients must agree to tissue collection for correlative studies at the specified timepoints.
✓. Patients must consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291.
✓. Male aged 18 years and above.
✓. Histologically or cytologically confirmed prostate carcinoma.
✓. Presence of metastatic disease documented on imaging studies (bone scan, CT and/or MRI scans).
✓. Patients must meet at least one of the following AVPC criteria:
✓. Patients must have documented evidence of progressive disease as defined by any of the following:

✕. Any prior treatment for CRPC with carboplatin, cisplatin or cabazitaxel.
✕. Patients who have received more than one line of chemotherapy for prostate cancer. Any number of prior hormonal or targeted therapies are allowed.
✕. Patients who have not recovered from adverse events secondary to systemic therapy (except for LHRH agonist or antagonist treatment for prostate cancer, and bisphosphonates or RANK ligand inhibitors for bone strengthening), major surgery or radiotherapy for the treatment of prostate cancer to a grade \</= 2.
✕. Any unresolved toxicity (CTCAE Grade ≥2) from previous anti-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
✕. Active uncontrolled infection (patients completing a course of antibiotic or antiviral therapy whose infection is deemed to be controlled may be allowed on study after discussion with the PI; the PI will serve as the final arbiter regarding eligibility).
✕. Active or symptomatic viral hepatitis or chronic liver disease.
✕. A history of extensive bilateral lung disease of non-malignant etiology.
✕. A malignancy \[other than the one treated in this study\] which has a '≥ 30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix or Ta urothelial carcinomas).