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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Polaris Group
Sponsor:
Information provided by (Responsible Party):
Polaris Group
ClinicalTrials.gov Identifier:
NCT01665183
First received: August 8, 2012
Last updated: May 15, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors
Drug: ADI-PEG 20
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma or Other Advanced Solid Malignancies

Resource links provided by NLM:


Further study details as provided by Polaris Group:

Primary Outcome Measures:
  • Number of participants with adverse events. [ Time Frame: Course of study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with objective responses. [ Time Frame: Course of study. ] [ Designated as safety issue: No ]

Estimated Enrollment: 89
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADI-PEG 20
arginine deiminase formulated with polyethylene glycol
Drug: ADI-PEG 20
Other Name: arginine deiminase formulated with polyethylene glycol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665183

Contacts
Contact: John Bomalaski, MD 858-452-6688 ext 114 jbomalaski@polarispharma.com
Contact: Gisela Peterson, MD, CCRC 858-452-6688 ext 127 gpeterson@polarispharma.com

Locations
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States
Contact: Siqing Fu, MD    858-452-6688 ext 127      
Principal Investigator: Siqing Fu, MD         
Taiwan
NCKUH Recruiting
Tainan, Taiwan, 704
Principal Investigator: Li-Tzong Chen, MD         
Sponsors and Collaborators
Polaris Group
Investigators
Principal Investigator: Siqing Fu, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Polaris Group
ClinicalTrials.gov Identifier: NCT01665183     History of Changes
Other Study ID Numbers: POLARIS2012-005
Study First Received: August 8, 2012
Last Updated: May 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Polaris Group:
argininosuccinate synthetase
arginine
arginine deiminase

Additional relevant MeSH terms:
Melanoma
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on June 28, 2015