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Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma

Primary Purpose

Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ADI-PEG 20
Sponsored by
Polaris Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors focused on measuring argininosuccinate synthetase, arginine, arginine deiminase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed diagnosis of advanced solid tumor (dose escalation component) or metastatic melanoma (uveal or cutaneous) (doses escalation and MTD expansion components) or platinum-resistant (tumor progression within a year after the completion of platinum-based therapy) ovarian carcinoma (high grade serous, endometrial or poorly differentiated endometrioid) or HCC that has failed treatment with sorafenib or did not tolerate sorafenib or refused sorafenib, or HCC with coexistent BCT that has or has not been treated with chemotherapy, or BCT that has or has not been treated with chemotherapy. For HCC and HCC with coexistent BCT, cirrhotic status of Child-Pugh grade A-B7 must be present. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix C). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR.
  2. Ovarian cancer, or HCC, or HCC with coexistent BCT, or BCT only tissue either from an archived specimen or from a new biopsy of sufficient amount and quality should be available for IHC determination of ASS status to be performed retrospectively for the ovarian cancer, or HCC, or HCC with coexistent BCT, or BCT only cohorts. Subjects with no tissue available would require a biopsy.
  3. Unresectable disease or patient refused surgery.
  4. Progressive disease if treated with chemotherapy, radiotherapy, surgery or immunotherapy. If prior radiation was given, the measurable disease should be outside the radiation port. Unequivocal progression of HCC/BTC lesions previously treated with catheter-based therapy including transarterial chemoembolization or radioembolization is allowed.
  5. Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).
  6. Age ≥ 18 years.
  7. ECOG performance status of 0 - 1.
  8. No prior systemic therapy, immunotherapy, investigational agent, chemoembolization, radioembolization or radiation therapy within the last 4 weeks.
  9. Fully recovered from any prior surgery and no major surgery within 4 weeks of initiating treatment, except for gamma knife which can take place within 2 weeks. Surgery for placement of vascular access devices is acceptable.

Exclusion Criteria:

  1. Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment. For the HCC, HCC/BTC and BTC subgroups hepatitis C infection and hepatitis B infection if controlled with antiviral therapy are allowable.
  2. Pregnancy or lactation.
  3. Expected non-compliance.
  4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
  5. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and investigator may be allowed upon agreement with both.
  6. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current cancer diagnosis.
  7. Subjects who had been treated with ADI-PEG 20 previously.
  8. History of seizure disorder not related to underlying cancer.
  9. Known HIV positivity (testing not required).

Sites / Locations

  • MD Anderson Cancer Center
  • NCKUH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADI-PEG 20

Arm Description

arginine deiminase formulated with polyethylene glycol

Outcomes

Primary Outcome Measures

Number of participants with adverse events.

Secondary Outcome Measures

Number of participants with objective responses.

Full Information

First Posted
August 8, 2012
Last Updated
February 24, 2016
Sponsor
Polaris Group
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1. Study Identification

Unique Protocol Identification Number
NCT01665183
Brief Title
Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma
Official Title
Phase 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma or Other Advanced Solid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polaris Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrades arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well known chemotherapy cisplatin, and the safety and potential efficacy of this combination will be explored in patients with cancers that require arginine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors
Keywords
argininosuccinate synthetase, arginine, arginine deiminase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADI-PEG 20
Arm Type
Experimental
Arm Description
arginine deiminase formulated with polyethylene glycol
Intervention Type
Drug
Intervention Name(s)
ADI-PEG 20
Other Intervention Name(s)
arginine deiminase formulated with polyethylene glycol
Primary Outcome Measure Information:
Title
Number of participants with adverse events.
Time Frame
Course of study.
Secondary Outcome Measure Information:
Title
Number of participants with objective responses.
Time Frame
Course of study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of advanced solid tumor (dose escalation component) or metastatic melanoma (uveal or cutaneous) (doses escalation and MTD expansion components) or platinum-resistant (tumor progression within a year after the completion of platinum-based therapy) ovarian carcinoma (high grade serous, endometrial or poorly differentiated endometrioid) or HCC that has failed treatment with sorafenib or did not tolerate sorafenib or refused sorafenib, or HCC with coexistent BCT that has or has not been treated with chemotherapy, or BCT that has or has not been treated with chemotherapy. For HCC and HCC with coexistent BCT, cirrhotic status of Child-Pugh grade A-B7 must be present. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix C). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR. Ovarian cancer, or HCC, or HCC with coexistent BCT, or BCT only tissue either from an archived specimen or from a new biopsy of sufficient amount and quality should be available for IHC determination of ASS status to be performed retrospectively for the ovarian cancer, or HCC, or HCC with coexistent BCT, or BCT only cohorts. Subjects with no tissue available would require a biopsy. Unresectable disease or patient refused surgery. Progressive disease if treated with chemotherapy, radiotherapy, surgery or immunotherapy. If prior radiation was given, the measurable disease should be outside the radiation port. Unequivocal progression of HCC/BTC lesions previously treated with catheter-based therapy including transarterial chemoembolization or radioembolization is allowed. Measurable disease as assessed by RECIST 1.1 criteria (Appendix A). Age ≥ 18 years. ECOG performance status of 0 - 1. No prior systemic therapy, immunotherapy, investigational agent, chemoembolization, radioembolization or radiation therapy within the last 4 weeks. Fully recovered from any prior surgery and no major surgery within 4 weeks of initiating treatment, except for gamma knife which can take place within 2 weeks. Surgery for placement of vascular access devices is acceptable. Exclusion Criteria: Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment. For the HCC, HCC/BTC and BTC subgroups hepatitis C infection and hepatitis B infection if controlled with antiviral therapy are allowable. Pregnancy or lactation. Expected non-compliance. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and investigator may be allowed upon agreement with both. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current cancer diagnosis. Subjects who had been treated with ADI-PEG 20 previously. History of seizure disorder not related to underlying cancer. Known HIV positivity (testing not required).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siqing Fu, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
NCKUH
City
Tainan
ZIP/Postal Code
704
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma

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