Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers

Sponsor

Alaunos Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00421213

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

8.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study of safety of a new organic arsenic compound in the treatment of hematological malignancies.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Neoplasms Bone Marrow Neoplasms Non-Hodgkin's Lymphoma	Drug: Darinaparsin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm	Drug: Darinaparsin 300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months. Other Names: ZIO-101

Arm

Intervention/Treatment

Experimental: Single Arm

Drug: Darinaparsin

300mg/m2 of Darinaparsin given daily for five consecutive days to be repeated every 28 days for up to six months.

Other Names:

ZIO-101

Outcome Measures

Primary Outcome Measures

Response Rate [6 months]

Secondary Outcome Measures

toxicities [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Hodgkin's or non-Hodgkin's Lymphoma.
≥ 1 prior therapy and currently requiring therapy.
Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
≥ 18 years of age.
ECOG performance score ≤ 2 (see Appendix 2).
Life-expectancy ≥ 2 months.
Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
The following clinical laboratory values < 2 weeks before Baseline:

Creatinine ≤ 2X upper limit of normal (ULN).
Total bilirubin ≤ 2X ULN.
Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN.

Exclusion Criteria

New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix ) within 6 months before Baseline or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥grade-2 atrioventricular (AV) block or left bundle branch block (LBBB).
Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
Uncontrolled infection.
Prior seizures ≥ grade-3 in CTC v.3 criteria.
Arsenic allergy.
Significant neuropathology, defined as grade > 2 per CTCAE Version 3.0.
Confusion or dementia.
Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.

Contacts and Locations

Locations

	City	State	Country
1	Miami	Florida	United States
2	Chicago	Illinois	United States
3	Bethesda	Maryland	United States
4	Fargo	North Dakota	United States
5	Sioux Falls	South Dakota	United States
6	Morgantown	West Virginia	United States