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

NCT00113334 | Completed Phase 1 Results

• 1 other identifier: 2003-1027
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Response rate defined as percentage of number of complete response or partial response in total number of participants treated. Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): \>20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1/\> new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD. Trial conducted by Simon's optimal two-stage design and response rate estimated accordingly. For status of PR or CR, changes in tumor measurements confirmed by repeat assessments performed at 6 weeks, no less than 4 weeks after criteria for response is first met.

  Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.

Study Arms (1)

ABT-510 (Thrombospondin)

EXPERIMENTAL

Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.

Drug: ABT-510

Interventions

ABT-510 DRUG

100 mg subcutaneously twice daily

Also known as: Thrombospondin Analogue

ABT-510 (Thrombospondin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Abbott: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Official Website

MeSH Terms

Conditions

Head and Neck Neoplasms; Thyroid Diseases

Interventions

NAc-Sar-Gly-Val-(d-allo-Ile)-Thr-Nva-Ile-Arg-ProNEt

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Endocrine System Diseases

Results Point of Contact

• Title: Edward Kim, MD, BS / Assistant Professor
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-6363

Study Officials

• Edward S. Kim, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2005
• First Posted: June 8, 2005
• Study Start: April 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: August 7, 2014
• Results First Posted: June 12, 2009

Record last verified: 2014-07

Locations

US (1)