Safety Study of Darinaparsin in Combination With Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) to Treat Lymphoma

NCT ID: NCT01139359

Last Updated: 2012-07-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-06-30

Brief Summary

This study is a Phase I trial of Darinaparsin in combination with CHOP for the treatment of lymphoma. Eligible patients will not have had any previous anti-cancer treatment and will be eligible to receive CHOP alone.

Conditions

Lymphoma

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm, darinaparsin and CHOP

open label, single arm, unblinded

Group Type: EXPERIMENTAL

darinaparsin

Intervention Type: DRUG

I.V. darinaparsin given in a dose escalation manner, once a day for 5 days per cycle.

CHOP

Intervention Type: DRUG

Cyclophosphamide 750 mg/m2 IV Day 8 of each Cycle; Doxorubicin 50 mg/m2 IV Day 8 of each Cycle; Vincristine 1.4 mg/m2 IV Day 8 of each Cycle; Prednisone 100 mg oral Days 8-12 of each Cycle.

Interventions

darinaparsin

I.V. darinaparsin given in a dose escalation manner, once a day for 5 days per cycle.

Intervention Type: DRUG

CHOP

Cyclophosphamide 750 mg/m2 IV Day 8 of each Cycle; Doxorubicin 50 mg/m2 IV Day 8 of each Cycle; Vincristine 1.4 mg/m2 IV Day 8 of each Cycle; Prednisone 100 mg oral Days 8-12 of each Cycle.

Intervention Type: DRUG

Other Intervention Names

ZIO-101; Zinapar(TM)

Eligibility Criteria

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 QTc.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alaunos Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan J. Lewis, MD, PhD

Role: STUDY_DIRECTOR

ZIOPHARM, Oncology, Inc.

Countries

United States

Other Identifiers

SGL1003

Identifier Type: -

Identifier Source: org_study_id