Clinical trial NCT00113334: Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer
Official title: A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Thrombospondin Analogue
ABT-510
Antiangiogenic agent
Lung
Skin
Thyroid
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2005-06-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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: White blood count (WBC) \>/= 3,000 cells/mm3, absolute neutrophil count (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 \* upper limit of normal (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 \* ULN and alkaline phosphatase \> 2.5 \* 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 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.

Primary outcomes:
measure: Response Rate
timeFrame: Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Edward S. Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: