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Phase 1 Trial of ADI-PEG 20 Plus Cisplatin in Patients With Argininousccinate Synthetase Deficient Advanced Tumors

This study is currently recruiting participants.
Verified August 2012 by Polaris Group
Sponsor:
Information provided by (Responsible Party):
Polaris Group
ClinicalTrials.gov Identifier:
NCT01665183
First received: August 8, 2012
Last updated: December 16, 2012
Last verified: August 2012
History of Changes
  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
Argininosuccinate Synthetase Deficient 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 Argininousccinate Synthetase (ASS) Deficient Advanced Solid Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 reponses. [ Time Frame: Course of study. ] [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: September 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: September 2013 (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 to 90 Years
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) (dose escalation and MTD expansion components).
  2. ASS (argininosuccinate synthetase) deficient tumor.
  3. Unresectable disease or patient refused surgery.
  4. Progressive disease if treated with chemotherapy, radiotherapy, surgery or immuno-therapy.
  5. Measurable disease as assessed by RECIST 1.1 criteria.
  6. Age ≥ 18 years.
  7. Karnofsky performance status of ≥ 70.
  8. Acceptable hematologic and chemistry laboratory values.

Exclusion Criteria:

  1. Serious infection.
  2. Pregnancy or lactation.
  3. Uncontrolled intercurrent illness.
  4. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia).
  5. History of seizure disorder not related to underlying cancer.
  6. Known HIV positivity (testing not required).
  7. Uncontrolled or progressing CNS metastases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665183

Locations
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States
Contact: Siqing Fu, MD     713-792-4318        
Principal Investigator: Siqing Fu, 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: December 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Polaris Group:
argininosuccinate synthetase
arginine
arginine deiminase

Additional relevant MeSH terms:
Cisplatin
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013