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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00113334
First received: June 7, 2005
Last updated: April 24, 2009
Last verified: April 2009
  Purpose

The goals of this clinical research study are to see how individuals with advanced head and neck cancer respond to treatment with the new drug thrombospondin (ABT-510) and to learn how effective it is in destroying cancer cells. The safety of ABT-510 and the effect ABT-510 has on cells in the body will also be studied.


Condition Intervention Phase
Head and Neck Cancer
Drug: ABT-510
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: April 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-510 (Thrombospondin) Drug: ABT-510
100 mg subcutaneously twice daily
Other Name: Thrombospondin Analogue

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 </= 2.0 mg/dL, albumin >/= 2.5 g/dL.
  • Transaminases (SGOT and/or SGPT) may be up to 2.5 x ULN if alkaline phosphatase is </= ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are </= ULN. 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.
  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: NCT00113334

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Abbott
Investigators
Principal Investigator: Edward S. Kim, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Edward S. Kim, M.D./Assistant Professor, University of Texas M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00113334     History of Changes
Other Study ID Numbers: 2003-1027
Study First Received: June 7, 2005
Results First Received: April 24, 2009
Last Updated: April 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Thrombospondin Analogue
ABT-510
Antiangiogenic agent
Lung
Skin
Thyroid

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on July 26, 2014