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

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Alaunos Therapeutics

Status and phase

Completed
Phase 2

Conditions

Hematologic Neoplasms
Non-Hodgkin's Lymphoma
Bone Marrow Neoplasms

Treatments

Drug: Darinaparsin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00421213
SGL2003

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

50 participants in 1 patient group

Single Arm
Experimental group
Treatment:
Drug: Darinaparsin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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