Safety Study of Darinaparsin in Combination With Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) to Treat Lymphoma
This study has been withdrawn prior to enrollment.
(Study enrollment was withdrawn as it is no longer the sponsor's intention to study this indication under this protocol.)
Information provided by (Responsible Party):
First received: June 4, 2010
Last updated: July 18, 2012
Last verified: July 2012
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.
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Define Toxicity profile [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
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)
- Maximum Tolerated Dose [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
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).
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2011 (Final data collection date for primary outcome measure)
Experimental: Single Arm, darinaparsin and CHOP
open label, single arm, unblinded
I.V. darinaparsin given in a dose escalation manner, once a day for 5 days per cycle.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139359
||Jonathan J. Lewis, MD, PhD
||ZIOPHARM, Oncology, Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 4, 2010
||July 18, 2012
||United States: Food and Drug Administration
Keywords provided by Ziopharm:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 11, 2014
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic