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A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer

This is a phase Ib/II, single-center, open-label study designed to assess the safety,
tolerability, pharmacokinetics, and biologic efficacy of ABT-510 (thrombospondin).
Participants will be patients with incurable head and neck cancer.

Patients will begin at a fixed dose level of thrombospondin subcutaneously twice daily.
Cycles of treatment are 28 days (4 weeks). Patients will be treated with thrombospondin
until progression of tumor or toxicity.

Inclusion Criteria:

- Patient has histologically proven squamous cell carcinoma of the head and neck that
is not amenable to curative therapy, including radiation or surgery (including
surgery following induction chemotherapy or chemo-radiation).

- Patient's tumor is biopsy accessible.

- Patient has a Karnofsky performance status >/= 70.

- Patient has adequate bone marrow function: WBC >/= 3,000 cells/mm3, ANC >/= 1,500
cells/mm3, platelet count >/= 100,000 cells/mm3, Hgb >/= 9.0 g/dL.

- Patient has adequate liver function: total bilirubin level >/= 2.5 g/dL.

- Transaminases (SGOT and/or SGPT) may be up to 2.5 x ULN if alkaline phosphatase is
However, patients who have both transaminase elevation > 1.5 x ULN and alkaline
phosphatase > 2.5 x ULN are not eligible for this study.

- 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.

Exclusion Criteria:

- 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 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

3 Years

Safety Issue:


Principal Investigator

Edward S. Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2005

Completion Date:

March 2008

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Cancer
  • Thrombospondin Analogue
  • ABT-510
  • Antiangiogenic agent
  • Lung
  • Skin
  • Thyroid
  • Head and Neck Neoplasms



University of Texas MD Anderson Cancer Center Houston, Texas  77030