ADI-PEG in Patients With Metastatic Melanoma

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ADI PEG

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Dose-Response Relationship, Drug, Polyethylene Glycol, Arginine Deiminase

Eligibility Criteria

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

Inclusion criteria: Histologically confirmed metastatic melanoma Nonresectable disease Measurable or evaluable disease Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy Recovered from prior surgery Karnofsky performance status 70 or higher Expected survival of at least 12 weeks Bilirubin less than 2.0 mg/dL Albumin greater than 3.0 g/dL SGOT less than 5 times upper limit of normal (ULN) Alkaline phosphatase less than 5 times ULN Ammonia less than 55 microg/dL Glucose greater than 60 mg/dL Amylase less than 1.5 times ULN Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Patients must use 2 forms of effective contraception Exclusion criteria: Prior therapy within the past 4 weeks Ascites or pleural effusion Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease) Pregnant or nursing Concurrent enrollment in another IND study Serious infection requiring antibiotics

Sites / Locations

Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00029900

First Posted

January 24, 2002

Last Updated

March 24, 2015

Sponsor

FDA Office of Orphan Products Development

1. Study Identification

Unique Protocol Identification Number

NCT00029900

Brief Title

ADI-PEG in Patients With Metastatic Melanoma

Official Title

Phase I Testing of ADI-PEG in Metastatic Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2002

Overall Recruitment Status

Completed

Study Start Date

September 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

FDA Office of Orphan Products Development

4. Oversight

5. Study Description

Brief Summary

This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.

Detailed Description

The use of amino acid degrading enzymes derived from microbial sources has proven to be an effective means of controlling some forms of cancer auxotrophic for nonessential amino acids. Recently it has been shown that human melanomas are auxotrophic for arginine. As arginine is a nonessential amino acid for humans, elimination of it may prove to be an effective method for controlling cancer. Laboratory studies have provided promising results with the arginine-degrading enzyme arginine deiminase (ADI) coupled to polyethylene glycol (PEG) to enhance its circulating half-life. In this study, patients each receive 3 intramuscular treatments of ADI-SS PEG over a 4-week period. There are 4 cohorts of patients each receiving a different dose level. Pharmacokinetics, pharmacodynamics, safety and toxicity, and immunogenicity studies will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma, Neoplasm Metastasis

Keywords

Dose-Response Relationship, Drug, Polyethylene Glycol, Arginine Deiminase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ADI PEG

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria: Histologically confirmed metastatic melanoma Nonresectable disease Measurable or evaluable disease Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy Recovered from prior surgery Karnofsky performance status 70 or higher Expected survival of at least 12 weeks Bilirubin less than 2.0 mg/dL Albumin greater than 3.0 g/dL SGOT less than 5 times upper limit of normal (ULN) Alkaline phosphatase less than 5 times ULN Ammonia less than 55 microg/dL Glucose greater than 60 mg/dL Amylase less than 1.5 times ULN Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Patients must use 2 forms of effective contraception Exclusion criteria: Prior therapy within the past 4 weeks Ascites or pleural effusion Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease) Pregnant or nursing Concurrent enrollment in another IND study Serious infection requiring antibiotics

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Melanoma, Neoplasm Metastasis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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