Malignant MelanomaPhase 1NCT00111696
Study of the Tumor Saturation and Biological Activity of MEDI-522 (Abergrin) in Patients With Advanced Malignant Melanoma
A Phase 1 study testing MEDI-522 in people with Malignant Melanoma, run by MedImmune LLC at 1 site in United States.
Trial summary
To describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- MEDI-522
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Histologically confirmed, unresectable, Stage IV or recurrent malignant melanoma (based on American Joint Committee on Cancer [AJCC] staging)
- Prior therapy with chemotherapy and/or immunotherapy for malignant melanoma is allowed, provided that therapy ended prior to study entry and all treatment related toxicities have resolved
- Measurable disease (based on Response Evaluation Criteria in Solid Tumors [RECIST] criteria) defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques, or as greater than or equal to 10 mm with a spiral computed tomography (CT) scan
- Have melanoma that can be biopsied once before, and at least twice after, MEDI-522 treatment
- Males and females of at least 18 years of age at the time of study entry
- Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum B human chorionic gonadotropin (bHCG) pregnancy test within 3 days prior to study entry; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device [IUD], condom, diaphragm with spermicide, cervical cap, abstinence, or sterile sexual partner) at the time informed consent is signed (women only) or at the time of the initiation of MEDI-522 (men only), and must agree to continue using such precautions while receiving MEDI-522 and for 30 days after the final dose of MEDI-522
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 16 weeks
- WBC greater than or equal to 3000/mm(3), absolute neutrophil count (ANC) greater than or equal to 1,500/mm(3), platelet count greater than or equal to 100,000/mm(3)
- Bilirubin greater than or equal to 1.5 mg/dL [unless due to Gilbert's syndrome (unconjugated hyperbilirubinemia) in which case the bilirubin should be <= 3.5 mg/dL]; aspartate transaminase (AST)/alanine transaminase (ALT) greater than or equal to 3 x upper limit of normal (ULN); serum creatinine greater than or equal to 1.5 mg/dL; hepatic alkaline phosphatase greater than or equal to 3.0 x ULN; prothrombin time (PT) or international normalized ratio (INR) within normal range (unless a patient is receiving anticoagulation therapy); or partial thromboplastin time (PTT) within normal range
- Patients who have had prior radiation therapy are eligible, provided that therapy was palliative in nature, not in the area where the tumor will be biopsied, and all radiation-related toxicities have resolved
- Patients who had prior major surgery are eligible if at least 4 weeks have passed since their surgery. All surgical wounds must have healed.
- All toxicities related to prior adjuvant therapy must have resolved.
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the patient prior to receipt of any study medication or beginning study procedures
Who cannot join
- Pregnancy or nursing
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
- Current or planned participation (from day of study entry through 30 days after last dose of MEDI-522) in a research protocol in which an investigational agent may be administered
- Received an investigational agent within 4 weeks prior to study entry
- Known brain metastases or primary brain tumors
- History of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, T1a or T1b prostate cancer noted incidentally during a transurethral resection of the prostate (TURP) with prostate-specific antigen (PSA) values within normal limits since TURP, or superficial bladder cancer
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- Any evidence of or history, elicited by the investigator, of symptomatic cerebrovascular events (i.e., stroke or transient ischemic attack) within 6 months prior to study entry; or any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (e.g., warfarin or heparin).
- Currently requiring anticoagulation (excluding use of heparin flush solutions for maintenance of catheter lines) for any thromboembolic disease based on medical history and physical examination
- Any current evidence of hematemesis, melena, hematochezia, or gross hematuria
- History or presence of bleeding diatheses
- Elective surgery planned during the study period through 30 days after the last dose of MEDI-522
- History of hypersensitivity to a previously administered monoclonal antibody
- History of immunodeficiency
- Patients with a clinical diagnosis of Acquired Immune Deficiency Syndrome (AIDS) or known active viral hepatic infections
- A prior myocardial infarction or angina, or uncontrolled/refractory hypertension within 6 months prior to study entry
- Any evidence of an active infection requiring parenteral anti-infective therapy
- Prior treatment with MEDI-522 or MEDI-523
- A general medical or psychological condition or behavior, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase I Study of the Tumor Saturation and Biological Activity of MEDI-522 (Abergrin), a Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Advanced Malignant Melanoma
To describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma.
- Conditions
- Malignant Melanoma
- Being tested
- MEDI-522
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-522Biological
Supplied at a concentration of 50 mg/mL in both 2 mL and 10mL vials
| Study group | Role | What they receive |
|---|---|---|
| MEDI-522 | Experimental | Drug Receives: Biological: MEDI-522 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study is to describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma.
Measured: Baseline to disease progression
Secondary outcomes (1)
Describe tumor and endothelial cell viability induced by MEDI-522.
Measured: Baseline and two post-therapy points after week 3 and at time of 1st disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2005 (estimated)
- Study startMay 2005
- Primary completionAug 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stergios Moschos, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111696
- Sponsor's protocol ID
- MI-CP121
- Other IDs
- CRRI #0305014, UPCI 05-025
- Status last verified
- Mar 2012
- First submitted
- 24 May 2005
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Tumor Saturation and Biological Activity of MEDI-522 (Abergrin), a Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Advanced Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00111696
- Acronym / sponsor ID
- MI-CP121
- Conditions
- Malignant Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 25 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEDI-522 | Experimental | Biological: MEDI-522Drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed, unresectable, Stage IV or recurrent malignant melanoma (based on American Joint Committee on Cancer [AJCC] staging)
- Prior therapy with chemotherapy and/or immunotherapy for malignant melanoma is allowed, provided that therapy ended prior to study entry and all treatment related toxicities have resolved
- Measurable disease (based on Response Evaluation Criteria in Solid Tumors [RECIST] criteria) defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques, or as greater than or equal to 10 mm with a spiral computed tomography (CT) scan
- Have melanoma that can be biopsied once before, and at least twice after, MEDI-522 treatment
- Males and females of at least 18 years of age at the time of study entry
Key exclusion criteria (18 listed)
- Pregnancy or nursing
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
- Current or planned participation (from day of study entry through 30 days after last dose of MEDI-522) in a research protocol in which an investigational agent may be administered
- Received an investigational agent within 4 weeks prior to study entry
- Known brain metastases or primary brain tumors
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 |
|---|---|---|
| MEDI-522Supplied at a concentration of 50 mg/mL in both 2 mL and 10mL vials | Biological | MEDI-522 |
Primary outcome
The primary outcome of this study is to describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma.
Time frame: Baseline to disease progression
1 secondary outcome
Describe tumor and endothelial cell viability induced by MEDI-522.
Time frame: Baseline and two post-therapy points after week 3 and at time of 1st disease progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
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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.
Stergios Moschos, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-522 in people with Malignant Melanoma, run by MedImmune LLC 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 14 inclusion and 18 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 14 Mar 2012. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome of this study is to describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma. (time frame: Baseline to disease progression). 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 14 Mar 2012.