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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objectives:

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. To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks.

Secondary Objective:

1. To determine the anti-tumor effects of ZIO-101.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Ziopharm

Criteria

Inclusion Criteria:

1. Patients with histological confirmation solid malignancy refractory to conventional standard therapies for their condition.

2. 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.

3. Pediatric patients will be eligible at the discretion of the primary investigator.

4. ECOG performance status score

5. 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.

6. Patients must provide written informed consent prior to treatment.

7. At least four weeks from completion of prior therapy to day 1 of study drug.

8. 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).

9. Evidence of adequate multi-organ functional status as reflected by the following clinical laboratory values: - Serum creatininecalculated creatinine clearancenormal limit. - Alanine aminotransferase (ALT), OR aspartate aminotransferase (AST)

10. 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.

Exclusion Criteria:

1. Uncontrolled systemic infection (documented with microbiological studies).

2. 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.

3. Concomitant therapy for solid cancer.

4. Pregnant subjects and those who are breast-feeding.

5. 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.

6. Documented personal or family history of prolonged QT syndrome.

7. 12 lead electrocardiogram with a corrected QT interval >/= 460 milliseconds.

8. History of confusion or dementia.

9. History of seizure disorder.