MelanomaPhase 2NCT00066196
Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
A Phase 2 study testing MEDI--522 and Integrin + Dacarbazine in people with Melanoma and Malignant Metastatic Melanoma, run by MedImmune LLC at 25 sites in United States.
Trial summary
The primary objectives of this study are: To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic melanoma. To determine the safety of MEDI-522 ± DTIC in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Malignant Metastatic Melanoma
- What is being tested?
- MEDI--522 and Integrin + Dacarbazine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 25 sitesUnited States
- Study dates
- Aug 2003to Jun 2007
- Phase
- Phase 2
- 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
- Patients must meet all of the following criteria at the time of randomization:
- Histologically confirmed, unresectable, Stage IV metastatic melanoma (AJCC staging), with at least one measurable lesion defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ³ 20 mm with conventional techniques or as ³ 10 mm with spiral computed tomography (CT) scan;
- Adult men and women of at least 18 years of age at the time of randomization;
- Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum β human chorionic gonadotropin (βhCG) pregnancy test within 3 days prior to randomization; 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 the informed consent is signed, and must agree to continue using such precautions while receiving MEDI-522 and for 30 days after the final dose of MEDI-522;
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1;
- Life expectancy of at least 16 weeks;
Show all 12Show fewer
- WBC ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥ 100,000/mm3;
- Bilirubin ≤ 1.5 mg/dL, aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 times upper limit of normal (ULN), serum creatinine ≤ 1.5 mg/dL, alkaline phosphatase ≤ 3.0 times ULN and prothrombin time (PT)/partial thromboplastin time (PTT) or international normalized ratio (INR) within normal range;
- Patients who have had prior treatment with adjuvant immunotherapy are eligible for study randomization provided that therapy ended at least 4 weeks prior to randomization;
- Patients who had prior surgery are eligible if at least 4 weeks have passed since their surgery;
- All toxicities related to prior adjuvant therapy must have resolved and all surgical wounds must have healed;
- Written informed consent and HIPAA authorization obtained from the patient prior to receipt of any study medication or beginning study procedures.
Who cannot join
- Patients must have none of the following at the time of randomization:
- Pregnancy or nursing;
- Prior therapy for metastatic melanoma including chemotherapy, radiotherapy, hormonal therapy, or biologics;
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer;
- Current or planned participation (from the day of randomization through 30 days after the last dose of MEDI-522) in a research protocol in which an investigational agent or therapy may be administered;
- Received an investigational agent within 4 weeks prior to randomization;
Show all 23Show fewer
- Known brain metastases or primary brain tumors, ocular melanoma, symptomatic pleural effusion or ascites requiring paracentesis;
- 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 b prostate cancer noted incidentally during a transurethral resection of prostate (TURP) with prostate-specific antigen (PSA) values within normal limits since TURP, or superficial bladder cancer;
- History of pulmonary embolus.
- Any history or evidence of pulmonary embolism or thrombophlebitis (including deep vein thrombosis) requiring anticoagulant therapy (i.e., warfarin or heparin).
- Currently requiring therapeutic anticoagulation.
- Any 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 hypersensitivity to DTIC;
- History of immunodeficiency;
- Known human immunodeficiency virus (HIV) or known active viral hepatic infections;
- A prior myocardial infarction or angina, or uncontrolled/refractory hypertension within 6 months prior to randomization;
- A prior stroke or transient ischemic attack within the past 6 months;
- An active infection requiring systemic antiinfective 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
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Boston Medical Center
Boston, Massachusetts, 02118
HemOnc Care, P.C.
Brooklyn, New York, 11235
UNC-Chapel Hill
Chapel Hill, North Carolina, 27599
Blumenthal Cancer Center
Charlotte, North Carolina, 28203
Discovery Alliance
Houston, Texas, 77030
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, 46202
Indiana University Medical Center
Indianapolis, Indiana, 46202
Kansas City Oncology & Hematology Group
Kansas City, Missouri, 64131
Pacific Shores Medical Group
Long Beach, California, 90813
Johns Hopkins University - SKCC at Johns Hopkins
Lutherville, Maryland, 21093
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Oncology Specialists, S.C.
Park Ridge, Illinois, 60069
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Providence Portland Medical Center
Portland, Oregon, 97213
Saint Francis Memorial Hospital
San Francisco, California, 94109
Cancer Institute Medical Group
Santa Monica, California, 90404
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
The Melanoma Center of St. Louis
St Louis, Missouri, 63131
Medical Group of North County
Vista, California, 92083
About this study
Official title: A Phase II, Randomized, Open-Label Study Evaluating The Antitumor Activity Of MEDI-522, A Humanized Monoclonal Antibody Directed Against The Human Alpha V Beta 3 Integrin, ± Dacarbazine In Patients With Metastatic Melanoma
The primary objectives of this study are:
- To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic melanoma.
- To determine the safety of MEDI-522 ± DTIC in this patient population.
Read the detailed description
This is a Phase II, randomized, open-label, two-arm, multicenter study of MEDI 522 ± DTIC in previously untreated (other than adjuvant immunotherapy) patients with Stage IV metastatic melanoma (AJCC staging).
- Conditions
- Melanoma, Malignant Metastatic Melanoma
- Being tested
- MEDI--522, Integrin + Dacarbazine
- 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
IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.
Integrin + DacarbazineBiological
supplied in other formulations
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | Integrin + Dacarbazine Receives: Biological: Integrin + Dacarbazine |
| 1 | Active comparator | MEDI-522 Receives: Biological: MEDI--522 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore antitumor activity of MEDI-522 in patients with metastatic melanoma.
Measured: Screening and after every 2 cycles of treatment until disease progression. At least 4 weeks after a patient demonstrates response.
Secondary outcomes (1)
Determine the safety of MEDI-522 and/or DTIC in this patient population.
Measured: Every week until disease progression, and 30 days after disease progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startAug 2003
- Primary completionApr 2007 (estimated)
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luz Hammershaimb, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066196
- Sponsor's protocol ID
- MI-CP095
- Status last verified
- Jan 2008
- First submitted
- 5 Aug 2003
- Last updated
- 15 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Open-Label Study Evaluating The Antitumor Activity Of MEDI-522, A Humanized Monoclonal Antibody Directed Against The Human Alpha V Beta 3 Integrin, ± Dacarbazine In Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00066196
- Acronym / sponsor ID
- MI-CP095
- Conditions
- Melanoma, Malignant Metastatic Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Apr 2007 (estimated)
- Study completion
- Jun 2007 (actual)
- First posted
- 7 Aug 2003 (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.
The primary objectives of this study are:
- To explore the antitumor activity of MEDI-522 ± DTIC in patients with metastatic melanoma.
- To determine the safety of MEDI-522 ± DTIC in this patient population.
Detailed description
This is a Phase II, randomized, open-label, two-arm, multicenter study of MEDI 522 ± DTIC in previously untreated (other than adjuvant immunotherapy) patients with Stage IV metastatic melanoma (AJCC staging).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Biological: Integrin + DacarbazineIntegrin + Dacarbazine |
| 1 | Active comparator | Biological: MEDI--522MEDI-522 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed, unresectable, Stage IV metastatic melanoma (AJCC staging), with at least one measurable lesion defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ³ 20 mm with conventional techniques or as ³ 10 mm with spiral computed tomography (CT) scan;
- Adult men and women of at least 18 years of age at the time of randomization;
- Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative serum β human chorionic gonadotropin (βhCG) pregnancy test within 3 days prior to randomization; 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 the informed consent is signed, and must agree to continue using such precautions while receiving MEDI-522 and for 30 days after the final dose of MEDI-522;
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1;
- Life expectancy of at least 16 weeks;
Key exclusion criteria (23 listed)
- Pregnancy or nursing;
- Prior therapy for metastatic melanoma including chemotherapy, radiotherapy, hormonal therapy, or biologics;
- Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer;
- Current or planned participation (from the day of randomization through 30 days after the last dose of MEDI-522) in a research protocol in which an investigational agent or therapy may be administered;
- Received an investigational agent within 4 weeks prior to randomization;
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--522IV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL. | Biological | 1 |
| Integrin + Dacarbazinesupplied in other formulations | Biological | 2 |
Primary outcome
Explore antitumor activity of MEDI-522 in patients with metastatic melanoma.
Time frame: Screening and after every 2 cycles of treatment until disease progression. At least 4 weeks after a patient demonstrates response.
1 secondary outcome
Determine the safety of MEDI-522 and/or DTIC in this patient population.
Time frame: Every week until disease progression, and 30 days after 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 15 Jan 2008.
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Luz Hammershaimb, M.D. study director
MedImmune LLC
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI--522 and Integrin + Dacarbazine in people with Melanoma and Malignant Metastatic Melanoma, run by MedImmune LLC at 25 sites 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 23 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 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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 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?
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?
Explore antitumor activity of MEDI-522 in patients with metastatic melanoma. (time frame: Screening and after every 2 cycles of treatment until disease progression. At least 4 weeks after a patient demonstrates response.). 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 15 Jan 2008.