Phase I Trial of ZIO-101 in Patients With Solid Tumors

NCT00509782 | Completed Phase 1

• 1 other identifier: 2004-0909
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors.
2. 2.To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks.

Conditions

Solid Tumors

Keywords

Solid Tumors; Anti-Tumor Effects; ZIO-101

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  Daily for 5 consecutive days repeated every 4 weeks for 1 cycle; evaluation of 4-6 dose escalations to determine an MTD

Study Arms (1)

ZIO-101

EXPERIMENTAL

Drug: ZIO-101

Interventions

ZIO-101 DRUG

Starting Dose 78 mg/m\^2 intravenously daily for 5 consecutive days repeated every 4 weeks.

ZIO-101

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histological confirmation solid malignancy refractory to conventional standard therapies for their condition.
• Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents.
• Pediatric patients will be eligible at the discretion of the primary investigator.
• ECOG performance status score \</= 2.
• Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device), and must have a negative blood or urine pregnancy test within 1 week before beginning treatment. Sexually active men must also use acceptable contraceptive methods.
• Patients must provide written informed consent prior to treatment.
• At least four weeks from completion of prior therapy to day 1 of study drug.
• Baseline toxicity assessment less than or equal to grade 1 except treatment induced alopecia (NCI Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0).
• Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values: - Serum creatinine \</= 2 times the upper normal limit OR a calculated creatinine clearance \</= 50 cc/min. - Total bilirubin \</= 2 times the upper normal limit. - Alanine aminotransferase (ALT), OR aspartate aminotransferase (AST) \</= 3 times the upper limit of normal.
• Granulocytes in peripheral blood greater than or equal to 1 x 10(9) per liter, hemoglobin greater than or equal to 8.5 g/dL, and platelets greater than or equal to 50,000 cells/microL.

You may not qualify if:

• Uncontrolled systemic infection (documented with microbiological studies).
• Active heart disease as defined by an acute myocardial infarction within the previous 6 months before starting therapy, stable or unstable angina, clinically significant arrhythmia requiring medical management, OR New York Heart Association Classification of Functional Activities. Class 3: Patient has marked limitation in activities due to symptoms, even during less-than-ordinary activity and is comfortable only at rest OR Class 4: Severe limitations. Patient experiences symptoms even while at rest.
• Concomitant therapy for solid cancer.
• Pregnant subjects and those who are breast-feeding.
• History of an 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.
• Documented personal or family history of prolonged QT syndrome.
• lead electrocardiogram with a corrected QT interval \>/= 460 milliseconds.
• History of confusion or dementia.
• History of seizure disorder.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Alaunos Therapeutics: collaborator

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Tsimberidou AM, Camacho LH, Verstovsek S, Ng C, Hong DS, Uehara CK, Gutierrez C, Daring S, Stevens J, Komarnitsky PB, Schwartz B, Kurzrock R. A phase I clinical trial of darinaparsin in patients with refractory solid tumors. Clin Cancer Res. 2009 Jul 15;15(14):4769-76. doi: 10.1158/1078-0432.CCR-08-2984. Epub 2009 Jul 7.

  PMID: 19584162 RESULT

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Interventions

darinaparsin

Study Officials

• Razelle Kurzrock, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: July 31, 2007
• Study Start: May 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)