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A Phase I Dose Escalation Study of Darinaparsin in Combination With CHOP in Previously Untreated Patients With Lymphomas Who Are Scheduled to Receive CHOP Alone

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase I Dose Escalation Study of Darinaparsin in Combination With CHOP in Previously Untreated Patients With Lymphomas Who Are Scheduled to Receive CHOP Alone

Inclusion Criteria:

- Patients with histological or cytological confirmation of lymphoma who are previously
untreated and are scheduled to receive CHOP alone. Since the objective of the study
is the assessment of safety, eligible subjects may have any type of lymphoma
(Hodgkin's or non-Hodgkin's, T-cell or B-cell), as long as the scheduled therapy is
CHOP alone.

- Men and women of ≥18 years of age.

- ECOG performance score ≤2

- Life expectancy ≥12 weeks.

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements, to be conducted <2 weeks prior to first dose of study drug:

- Creatinine ≤1.5 × upper limit of normal (ULN) OR a calculated creatinine
clearance ≥60 cc/min

- Total bilirubin ≤2 × ULN

- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3 × ULN

- Granulocytes in peripheral blood ≥1 × 109/L, hemoglobin ≥10 g/dL, and platelets
≥50,000 /µL

- Adequate vascular access for repeated blood sampling.

- Men and women of childbearing potential must agree to use effective contraception
from Screening through 30 days after the last dose of study drug.

- Written informed consent in compliance with ZIOPHARM policies and the Human
Investigation Review Committee (IEC/IRB) having jurisdiction over the site.

Exclusion Criteria:

- Arsenic allergy.

- New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see
Appendix 3) within 6 months.

- Myocardial dysfunction defined as scintigraphically- (MUGA [multiple gated
acquisition scan], myocardial scintigram) or ultrasound-determined left ventricular
ejection fraction (LVEF) <50%.

- 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); or documented history of prolonged QTc.

- Pregnant and/or lactating women.

- Uncontrolled systemic infection (documented with microbiological studies).

- Metastatic brain or meningeal tumors. -Patients with seizure disorder requiring
medication (such as anti- branch block (LBBB); or documented history of prolonged

- History of confusion or dementia or neurological condition that could mask a
potential adverse response to the Study Drug, which may include transient ischemic
attack, Parkinson's disease, thrombotic or hemorrhagic stroke, Alzheimer's, and other
neurological disorders.

- Anticancer chemotherapy or immunotherapy for this indication.

- Radiotherapy during study or within 3 weeks of Study entry.

- Major surgery within 4 weeks of start of Study Drug dosing.

- Investigational drug therapy outside of this trial.

- History of invasive second primary malignancy diagnosed within the previous 3 years
except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated
surgically, and non-melanoma skin cancer.

- Substance abuse, medical, psychological, or social conditions that may interfere with
the patient's participation in the study or evaluation of Study results.

- Any condition that is unstable or could jeopardize the safety of the patient and
his/her compliance in the Study.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Define Toxicity profile

Outcome Description:

This is an open-label, dose-escalation Phase I study to define the toxicity profile and the maximum tolerated dose (MTD) of intravenously administered darinaparsin in combination with CHOP in patients with previously untreated lymphomas who are scheduled to receive CHOP alone (rituximab is not permitted)

Outcome Time Frame:

One Year

Safety Issue:


Principal Investigator

Jonathan J. Lewis, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

ZIOPHARM, Oncology, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

June 2011

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Darinaparsin
  • CHOP
  • Frontline
  • PTCL
  • B-cell
  • Lymphoma