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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421213
• Other study ID #: SGL2003
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2007
• Last updated: July 18, 2012
• Start date: December 2006
• Est. completion date: April 2012

Study information

• Verified date: July 2012
• Source: Ziopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: DCGI
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Hodgkin's or non-Hodgkin's Lymphoma.

2. = 1 prior therapy and currently requiring therapy.

3. Evaluable disease (defined by disease-specific criteria listed in Appendix 1)

4. = 18 years of age.

5. ECOG performance score = 2 (see Appendix 2).

6. Life-expectancy = 2 months.

7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.

8. No anti-cancer therapy exception of hydroxyurea = 3 weeks before Baseline (Day 1, Cycle 1).

9. 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

1. 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).

2. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).

3. Uncontrolled infection.

4. Prior seizures = grade-3 in CTC v.3 criteria.

5. Arsenic allergy.

6. Significant neuropathology, defined as grade > 2 per CTCAE Version 3.0.

7. Confusion or dementia.

8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Neoplasms
• Hematologic Neoplasms
• Lymphoma, Non-Hodgkin
• Neoplasms
• Non-Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziopharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		6 months	No
Secondary	toxicities		6 months	Yes