LymphomaPhase 1NCT00105313
Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
A Phase 1 study testing MEDI-507 in people with Lymphoma and Leukemia, run by MedImmune LLC at 11 sites in United States.
Trial summary
For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- MEDI-507
- How many people
- 80 participants
- Where
- 11 sitesUnited States
- Study dates
- Feb 2005to not given
- 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
Individuals may be eligible for this study if they are 18 years of age or older and:
- Have one of the following types of T-Cell Lymphoproliferative disorders such as Cutaneous T-cell Lymphoma (CTCL), Peripheral T-cell Lymphoma (PCTL), Large Cell Lymphoma (LGL), or Adult T-cell Lymphoma (ATL). Patients should have disease that is resistant or refractory to the front-line therapy, except ATL patients for whom there is no standard therapy.
- At least 30% of tumor cells must be CD2 positive.
- Karnofsky Performance status of greater than or equal to 70% (able to care for themselves; but unable to carry on normal activity or to do active work).
- At least 3 weeks must have passed since prior systemic cytotoxic chemotherapy, prolonged or cytolytic steroid therapy or major surgery, and all treatment-related toxicities must have resolved prior to the first MEDI-507 administration (except thrombocytopenia).
- Have no prior treatment with MEDI-507.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Maryland School of Medicine, Greenebaum Cancer Center
Baltimore, Maryland, 21201
Tufts New England Medical Center
Boston, Massachusetts, 02111
M.D. Anderson Cancer Center
Houston, Texas, 77030
Nevada Cancer Institute
Las Vegas, Nevada, 89135
USC/Norris Cancer Center
Los Angeles, California, 90033
Yale Cancer Center
New Haven, Connecticut, 06520
Kimmel Cancer Center, Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Washington University
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Ctr & Research Institute Div of Hem/Onc
Tampa, Florida, 33612
Georgetown University Medical Center, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27517
About this study
Official title: A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.
For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.
- Being tested
- MEDI-507
- Medical subject headings
- Lymphoma, Leukemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-507Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) or the optimal biological dose
(OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with
CD-2 positive lymphoproliferative disorders.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2005 (estimated)
- Study startFeb 2005
Why it stopped: After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luz Hammershaimb, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105313
- Sponsor's protocol ID
- MI-CP107
- Status last verified
- Jun 2007
- First submitted
- 11 Mar 2005
- Last updated
- 14 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label Dose Escalation Study to Evaluate MEDI-507 in Patients With CD2-Positive Lymphoma/Leukemia
- ClinicalTrials.gov ID
- NCT00105313
- Acronym / sponsor ID
- MI-CP107
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- First posted
- 14 Mar 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.
For primary objectives, we will determine the MTD and examine clinical responses and immune cell populations to determine an OBD, and describe the safety and tolerability of MEDI-507.
For the secondary objectives we will look at the antitumor activity of MEDI 507, PK, serum concentrations, and immunogenicity of MEDI-507, as well as time courses of depletion and recovery of CD2 positive and total T-Cell populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-507 | Drug | – |
Primary outcome
To determine the maximum tolerated dose (MTD) or the optimal biological dose
(OBD) of MEDI-507 based on safety and tolerability of MEDI-507 in patients with
CD-2 positive lymphoproliferative disorders.
Results and safety
The study was stopped early (reason given: After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2007.
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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.
Luz Hammershaimb, MD study director
MedImmune LLC
11 sites 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-507 in people with Lymphoma and Leukemia, run by MedImmune LLC at 11 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?
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: stopped early, as of the sponsor's last update on 14 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 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 was stopped early (reason given: After review of safety events and have decided that further dose escalation of MEDI-507 as a single agent is not feasible.). Results are not available in the source record.
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?
To determine the maximum tolerated dose (MTD) or the optimal biological dose. The study lists 3 primary outcomes in all. 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 Jun 2007.