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NCT00056992 · ClinicalTrials.gov registry record · Phase 2
Testing of ADI-PEG in Hepatocellular Carcinoma
A Phase 2 study, sponsored by FDA Office of Orphan Products Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT00056992 is a Phase 2 study that has completed, run by FDA Office of Orphan Products Development. The registered enrollment target is 34 participants.
The verdict
NCT00056992, a Phase 2 study, has completed, sponsored by FDA Office of Orphan Products Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
Amino acid deprivation therapy is an effective means for the treatment of some forms of cancer. Recently it has been found that human hepatocellular carcinomas (HCC) cell lines appear to require arginine for growth. Arginine is not an essential amino acid for human adults or infants as it can be synthesized from citrulline (for review see Rogers 1994). Therefore, selective elimination of arginine from the circulation may be a means of treating patients with metastatic melanoma or non resectable HCC. The enzyme arginine deiminase (ADI) metabolizes arginine into citrulline (Cunin 1986). However, ADI is only found in microbes and not in humans. ADI is therefore, highly immunogenic and has a short serum half-life following injection. These potential drawbacks (microbial source and thus viewed as foreign by the human immune system, and a short serum half-life) can be overcome by covalent attachment of polyethylene glycol (PEG) to argininedeiminase and termed this drug ADI-PEG 20. ADI-PEG 20 appears to be an effective anti-cancer treatment for human HCC. Pharmacokinetic and pharmacodynamic data indicates a once a week injection of 160 IU/m2 of ADI-PEG 20 eliminates all detectable arginine from the circulation for at least 7 days. This treatment appears to be well tolerated. The purpose of this study is to determine the efficacy of this treatment in patients with HCC. Efficacy is a primary end point of this study. No patients will recieve placebo.
Interventions
- DRUG ADI-PEG 20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2002-09 |
| Est. Completion | 2003-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00056992
The ClinicalTrials.gov registry entry for NCT00056992 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is FDA Office of Orphan Products Development, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ADI-PEG 20 is the first listed.
NCT00056992 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00056992 about?
NCT00056992 is a clinical study titled "Testing of ADI-PEG in Hepatocellular Carcinoma". Amino acid deprivation therapy is an effective means for the treatment of some forms of cancer. Recently it has been found that human hepatocellular carcinomas (HCC) cell lines appear to require arginine for growth. Arginine is not an essential amino acid for human adults or infants as it can be syn...
What is the current status of trial NCT00056992?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2002-09. Estimated completion is 2003-10.
What interventions are being tested in trial NCT00056992?
The interventions under investigation include: ADI-PEG 20 (DRUG).
Who is sponsoring clinical trial NCT00056992?
This trial is sponsored by FDA Office of Orphan Products Development, which has 10 total clinical trials registered on ClinicalTrials.gov.
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