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A Phase I Trial of ZIO-101 in Hematologic Cancers

NCT00592046 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2012-07-19

No results posted yet for this study

Summary

This study uses a new investigational (not yet approved by the FDA for widespread use) drug called ZIO-101, an organic arsenical. You must be diagnosed to have relapsed/refractory leukemia or lymphoma (blood cancer) and have tried other standard therapies.

This study is designed to determine whether ZIO-101 may be given safely. The study will also test whether ZIO-101 helps to treat blood cancer.

We anticipate that approximately 22 to 35 patients will take part in this study.

Arsenic has been used as a medicinal agent for centuries in many different cultures. Most recently in the United States, an inorganic arsenic compound was approved by the FDA for the treatment of patients with relapsed acute promyelocytic leukemia (APL). However, use of inorganic arsenic is limited by a narrow range of activity and systemic toxicity, most notably of the cardiac system.

ZIO-101 is an organic arsenic derivative. In vitro testing in both the National Cancer Institute (NCI) cancer cell panel and in vivo testing in a leukemia animal model demonstrated substantial activity of SGLU against hematologic cancers. In vitro testing of SGLU using the NCI human cancer cell panel also detected activity against lung, colon and brain cancers, melanoma, and ovary and kidney cancers. Moderate activity was seen against breast and prostate cancers cells. Data suggest that organic arsenic generates reactive oxygen species in the cells to induce apoptosis and cell cycle arrest.

Conditions

Interventions

DRUG

ZIO-101 (Darinaparsin)

ZIO-101 (Darinaparsin) given for five consecutive days to be repeated every 28 days for up to six months. This is a dose escalation study.

Sponsors & Collaborators

  • Alaunos Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00592046 on ClinicalTrials.gov