Hodgkin's DiseasePhase 2NCT00284804
A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease
A Phase 2 study testing MDX-060 in people with Hodgkin's Disease, run by Bristol-Myers Squibb at 17 sites in United States.
Trial summary
This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Disease
- What is being tested?
- MDX-060
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2005to Oct 2009
- 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
- Diagnosis of Hodgkin's disease [HD] (excluding HIV-associated HD)
- Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
- Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant
- ECOG Performance Status of 0-2
- Patients must have bi-measurable disease
- At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment
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- Life expectancy 12 weeks or greater
- Screening laboratory values must be met
- Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion.
Who cannot join
- Previous treatment with any anti-CD30 antibody
- History of allogeneic transplant
- Any tumor lesion 10cm or greater in diameter
- Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
- Any significant active or chronic infection
- Apparent active or latent tuberculosis (TB) infection
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- Patients who are pregnant or nursing
- Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
- Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
St. Francis Hospital Center
Beech Grove, Indiana, 46107
Division of Hematology/Oncology, Tufts-New England Medical Center
Boston, Massachusetts, 02111
Roswell Park Cancer Center
Buffalo, New York, 14263
Rush Cancer Institute
Chicago, Illinois, 60612
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope, National Medical Center
Duarte, California, 91010
California Oncology of the Central Valley
Fresno, California, 93710
M.D. Anderson Cancer Center, The University of Texas
Houston, Texas, 77030
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, 28078
American Health Network of Indiana
Indianapolis, Indiana, 46237
University of California, San Diego/Moores UCSD Cancer Center
La Jolla, California, 92093-0698
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506-9162
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Mount Sinai School of Medicine
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
H. Lee Moffitt Cancer & Research Institute
Tampa, Florida, 33612
About this study
Official title: An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease
This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.
Read the detailed description
Secondary objectives include:
- to characterize progression-free survival
- to characterize time to progression
- to determine response duration
- to characterize the effect of study drug on health-related quality of life
- to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population
- to characterize the immunogenicity response of MDX-060
- to characterize the safety of MDX-060, and
- to characterize the pharmacokinetic profile of MDX-060
- Conditions
- Hodgkin's Disease
- Being tested
- MDX-060
- Keywords
- relapsed or refractory Hodgkin's Disease
- Medical subject headings
- Hodgkin Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDX-060Drug
Also called anti-CD30
anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| MDX-060 plus standard of care | Experimental | MDX-060 in combination with gemcitabine Receives: Drug: MDX-060 |
| Standard of care | Active comparator | Gemcitabine Receives: Drug: MDX-060 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Day 50/57
Secondary outcomes (1)
Progression-free survival
Measured: Day 50/57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionMay 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medarex Medical Monitor, Study director, Medarex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284804
- Sponsor's protocol ID
- MDX060-05/05E
- Status last verified
- Sep 2015
- First submitted
- 30 Jan 2006
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00284804
- Acronym / sponsor ID
- MDX060-05/05E
- Conditions
- Hodgkin's Disease
- Keywords
- relapsed or refractory Hodgkin's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 1 Feb 2006 (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.
This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.
Detailed description
Secondary objectives include:
- to characterize progression-free survival
- to characterize time to progression
- to determine response duration
- to characterize the effect of study drug on health-related quality of life
- to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population
- to characterize the immunogenicity response of MDX-060
- to characterize the safety of MDX-060, and
- to characterize the pharmacokinetic profile of MDX-060
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDX-060 plus standard of care | Experimental | Drug: MDX-060MDX-060 in combination with gemcitabine |
| Standard of care | Active comparator | Drug: MDX-060Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of Hodgkin's disease [HD] (excluding HIV-associated HD)
- Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
- Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant
- ECOG Performance Status of 0-2
- Patients must have bi-measurable disease
Key exclusion criteria (9 listed)
- Previous treatment with any anti-CD30 antibody
- History of allogeneic transplant
- Any tumor lesion 10cm or greater in diameter
- Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
- Any significant active or chronic infection
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 |
|---|---|---|
| MDX-060Also: anti-CD30anti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg | Drug | MDX-060 plus standard of care, Standard of care |
Primary outcome
Overall response rate
Time frame: Day 50/57
1 secondary outcome
Progression-free survival
Time frame: Day 50/57
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 12 Oct 2015.
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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.
Medarex Medical Monitor study director
Medarex
17 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 MDX-060 in people with Hodgkin's Disease, run by Bristol-Myers Squibb at 17 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 9 inclusion and 9 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Overall response rate (time frame: Day 50/57). 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 12 Oct 2015.