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 August 2014 by Polaris Group
Information provided by (Responsible Party):
Polaris Group Identifier:
First received: August 8, 2012
Last updated: August 13, 2014
Last verified: August 2014

August 8, 2012
August 13, 2014
September 2012
October 2014   (final data collection date for primary outcome measure)
Number of participants with adverse events. [ Time Frame: Course of study. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01665183 on Archive Site
Number of participants with objective responses. [ Time Frame: Course of study. ] [ Designated as safety issue: No ]
Number of participants with objective reponses. [ Time Frame: Course of study. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Ph 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma
Phase 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Metastatic Melanoma or Other Advanced Solid Malignancies

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.

Not Provided
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cutaneous Melanoma, Uveal Melanoma, Ovarian Carcinoma or Other Advanced Solid Tumors
Drug: ADI-PEG 20
Other Name: arginine deiminase formulated with polyethylene glycol
Experimental: ADI-PEG 20
arginine deiminase formulated with polyethylene glycol
Intervention: Drug: ADI-PEG 20
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2014
October 2014   (final data collection date for primary outcome measure)

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 ~ 6 months after the completion of platinum-based therapy) ovarian carcinoma (high-grade serous, endometrial or poorly differentiated endometroid) that is ASS deficient by IHC (defined as <25 % cells ASS positive; see Table 1.4.1 for further details).
  2. Unresectable disease or patient refused surgery.
  3. Progressive disease if treated with chemotherapy, radiotherapy, surgery or immuno-therapy. If prior radiation was given, the measurable disease should be outside the radiation port.
  4. Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).
  5. Age ≥ 18 years.
  6. ECOG performance status of 0 - 1.
  7. No prior systemic therapy, immunotherapy, investigational agent, or radiation therapy within the last 4 weeks.
  8. 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.
  9. Female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. Females must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study. If positive HCG pregnancy test, further evaluation to rule out pregnancy must be performed according to GCP before this patient is claimed eligible.

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.
  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.
18 Years and older
United States
Polaris Group
Polaris Group
Not Provided
Principal Investigator: Siqing Fu, MD M.D. Anderson Cancer Center
Polaris Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP