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This study has been withdrawn prior to enrollment.
(Study enrollment was withdrawn as it is no longer the sponsor's intention to study this indication under this protocol.)
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT01139359
First received: June 4, 2010
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: darinaparsin
Drug: CHOP
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ziopharm:

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).


Enrollment: 0
Study Start Date: June 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm, darinaparsin and CHOP
open label, single arm, unblinded
Drug: darinaparsin
I.V. darinaparsin given in a dose escalation manner, once a day for 5 days per cycle.
Other Names:
  • ZIO-101
  • Zinapar(TM)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139359

Sponsors and Collaborators
Ziopharm
Investigators
Study Director: Jonathan J. Lewis, MD, PhD ZIOPHARM, Oncology, Inc.
  More Information

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT01139359     History of Changes
Other Study ID Numbers: SGL1003
Study First Received: June 4, 2010
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Ziopharm:
Lymphoma
Darinaparsin
CHOP
Frontline
PTCL
B-cell

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Doxorubicin
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 26, 2014