Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer

Exclusion Criteria

• •Patient has serum creatinine \< 2 mg/dl
• •Patient has signed a written informed consent.
• •Patient may have received any number of prior chemotherapeutic regimens for recurrent or metastatic disease.
• •The subject must not be pregnant or breastfeeding. All subjects (male and female) should practice contraception (e.g., barrier, hormonal, intrauterine device \[IUD\]) or abstain from sexual intercourse while in the study and for up to two months following completion of therapy.
• •The subject is able to self-administer or has a caregiver who can reliably administer subcutaneous (SC) injections.
• •Patient \>/= 18 years of age.
• •No biopsy accessible tissue.
• •Patient has received prior radiation therapy to biopsy site within the past 3 months. (Patient may have received palliative radiation within the past 2 weeks, but not to the biopsy site.)
• •Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient's understanding of the informed consent.
• •Patient requires total parenteral nutrition with lipids.
• •Patient has a history of uncontrolled heart disease including congestive heart failure, angina at rest, myocardial infarct in the last 6 months, uncontrolled hypertension with systolic blood pressure (BP) \>160 or diastolic BP \>90, systolic blood pressure (BP) \<90 or symptomatic hypotension, or symptomatic or potentially life-threatening tachycardia, bradycardia or arrhythmia.
• •Pregnant women and women who are currently breast-feeding may not participate in this study. All women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrolling in the study.
• •Serious infection or other intercurrent illness requiring immediate therapy.
• •The subject has a history of or currently exhibits clinically significant cancer related events of bleeding (e.g., hemoptysis). The subject has a recent history of (within 4 weeks from Study Day 1) or currently exhibits other clinically significant events of bleeding.
• •If subject is receiving therapeutic anticoagulation therapy, low dose anticoagulation for catheter prophylaxis will be permitted; PT/PTT must be within normal limits.
• •The patient has a history of or currently exhibits central nervous system (CNS) metastasis. Brain magnetic resonance imaging (MRI) within 28 days of enrollment is required to confirm the absence of CNS metastases.
• •Patient has received chemotherapy or biologic therapy within 3 weeks of registration.