RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-02-29

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06085729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Completion of informed consent prior to any study specific procedures. 2. Patients must agree to tissue collection for correlative studies at the specified timepoints. 3. Patients must consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291. 4. Male aged 18 years and above. 5. Histologically or cytologically confirmed prostate carcinoma. 6. Presence of metastatic disease documented on imaging studies (bone scan, CT and/or MRI scans). 7. Patients must meet at least one of the following AVPC criteria: * AVPC determination by immunohistochemistry. Tumor samples are considered negative (and thus abnormal) for RB1 and PTEN if their labeling index is ≤ 10% and positive (and thus aberrant) for Tp53 if their labeling index is ≥ 10%, where the labeling index is defined as the percentage of positive cells, and calculated as the number of positively stained epithelial cells divided by the total number of epithelial cells, at X200 magnification. * AVPC determination by DNA sequencing. The TP53, RB1 and PTEN genes will be considered aberrant if they contain exonic nonsynonymous missense or stop-gain mutations, frameshift or non-frameshift indels (insertions or deletions), and/or copy number losses. 8. Patients must have documented evidence of progressive disease as defined by any of the following: 9. Surgically or ongoing medically castrated, with baseline testosterone levels of ≤ 50 ng/dL (≤2.0 nM). 10. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2. 11. Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below: 12. Patients who have partners of childbearing potential (e.g., female that has not been surgically sterilized or who are not amenorrheic for ≥ 12 months) must be willing to use a method of birth control in addition to adequate barrier protection as determined to be acceptable by the investigator during the study and for 3 months after last dose of ADI-PEG 20 administration. In addition, men should not donate sperm during this period. 13. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.	1. Any prior treatment for CRPC with carboplatin, cisplatin or cabazitaxel. 2. Patients who have received more than one line of chemotherapy for prostate cancer. Any number of prior hormonal or targeted therapies are allowed. 3. 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. 4. 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). 5. 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). 6. Active or symptomatic viral hepatitis or chronic liver disease. 7. A history of extensive bilateral lung disease of non-malignant etiology. 8. 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). 9. Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples: include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, superior vena cava syndrome, extensive bilateral lung disease on HRCT scan, uncontrolled seizures, history of allogeneic organ transplant, history of primary immunodeficiency or any psychiatric disorder that prohibits obtaining informed consent. 10. Patients with symptomatic uncontrolled brain metastases or spinal cord compressions. A scan to confirm the absence of brain metastases is not required. 11. Prisoners or subjects who are involuntarily incarcerated. 12. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. 13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, pegylated compounds, or other agents used in this study.

Inclusion Criteria

Exclusion Criteria

1. Completion of informed consent prior to any study specific procedures.
2. Patients must agree to tissue collection for correlative studies at the specified timepoints.
3. Patients must consent to the MD Anderson Immunotherapy Platform laboratory protocol PA13-0291.
4. Male aged 18 years and above.
5. Histologically or cytologically confirmed prostate carcinoma.
6. Presence of metastatic disease documented on imaging studies (bone scan, CT and/or MRI scans).
7. Patients must meet at least one of the following AVPC criteria:
* AVPC determination by immunohistochemistry. Tumor samples are considered negative (and thus abnormal) for RB1 and PTEN if their labeling index is ≤ 10% and positive (and thus aberrant) for Tp53 if their labeling index is ≥ 10%, where the labeling index is defined as the percentage of positive cells, and calculated as the number of positively stained epithelial cells divided by the total number of epithelial cells, at X200 magnification.
* AVPC determination by DNA sequencing. The TP53, RB1 and PTEN genes will be considered aberrant if they contain exonic nonsynonymous missense or stop-gain mutations, frameshift or non-frameshift indels (insertions or deletions), and/or copy number losses.
8. Patients must have documented evidence of progressive disease as defined by any of the following:
9. Surgically or ongoing medically castrated, with baseline testosterone levels of ≤ 50 ng/dL (≤2.0 nM).
10. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
11. Patients must have adequate organ and bone marrow function measured within 7 days prior to treatment registration as defined below:
12. Patients who have partners of childbearing potential (e.g., female that has not been surgically sterilized or who are not amenorrheic for ≥ 12 months) must be willing to use a method of birth control in addition to adequate barrier protection as determined to be acceptable by the investigator during the study and for 3 months after last dose of ADI-PEG 20 administration. In addition, men should not donate sperm during this period.
13. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

1. Any prior treatment for CRPC with carboplatin, cisplatin or cabazitaxel.
2. Patients who have received more than one line of chemotherapy for prostate cancer. Any number of prior hormonal or targeted therapies are allowed.
3. 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.
4. 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).
5. 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).
6. Active or symptomatic viral hepatitis or chronic liver disease.
7. A history of extensive bilateral lung disease of non-malignant etiology.
8. 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).
9. Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events. Examples: include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, superior vena cava syndrome, extensive bilateral lung disease on HRCT scan, uncontrolled seizures, history of allogeneic organ transplant, history of primary immunodeficiency or any psychiatric disorder that prohibits obtaining informed consent.
10. Patients with symptomatic uncontrolled brain metastases or spinal cord compressions. A scan to confirm the absence of brain metastases is not required.
11. Prisoners or subjects who are involuntarily incarcerated.
12. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, pegylated compounds, or other agents used in this study.

Contacts and Locations

Study Contact

Ana Aparicio, MD

CONTACT

(713) 563-6969

aaparicio@mdanderson.org

Principal Investigator

Ana Aparicio, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Ana Aparicio, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-29

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-02-29

Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer