Head and Neck CancerPhase 1/2NCT00113334
Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer
A Phase 1/2 study testing ABT-510 in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- ABT-510
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Mar 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- ABT-510
- Keywords
- Head and Neck Cancer, Thrombospondin Analogue, ABT-510, Antiangiogenic agent, Lung, Skin, Thyroid
- Medical subject headings
- Head and Neck Neoplasms, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-510Drug
Also called Thrombospondin Analogue
100 mg subcutaneously twice daily
| Study group | Role | What they receive |
|---|---|---|
| ABT-510 (Thrombospondin) | Experimental | Fixed dose level of thrombospondin 100 mg subcutaneously twice daily. Receives: Drug: ABT-510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2005 (estimated)
- Study startApr 2005
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Edward S. Kim, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113334
- Sponsor's protocol ID
- 2003-1027
- Status last verified
- Jul 2014
- First submitted
- 7 Jun 2005
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00113334
- Acronym / sponsor ID
- 2003-1027
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Thrombospondin Analogue, ABT-510, Antiangiogenic agent, Lung, Skin, Thyroid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 Jun 2005 (estimated)
- Results
- Posted 12 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT-510 (Thrombospondin) | Experimental | Drug: ABT-510Fixed dose level of thrombospondin 100 mg subcutaneously twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-510Also: Thrombospondin Analogue100 mg subcutaneously twice daily | Drug | ABT-510 (Thrombospondin) |
Primary outcome
Response Rate
Time frame: Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward S. Kim, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABT-510 in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: Baseline to 6 weeks for PR or CR response assessment (minimal 4 week cycle + assessments). Overall study period 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.