CancerPhase 1NCT00806728
Study of MEDI-507 in With Steroid-Resistant Acute Graft-Versus-Host Disease
A Phase 1 study testing MEDI-507 in people with Cancer and Graft-Versus-Host Disease, run by MedImmune LLC at 10 sites in United States.
Trial summary
A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Graft-Versus-Host Disease
- What is being tested?
- MEDI-507
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 10 sitesUnited States
- Study dates
- May 1998to Dec 1998
- 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
- Allogeneic bone marrow or hematopoietic stem cell graft recipients
- Acute GVHD of at least grade II severity
- Failure of GVHD to improve on at least 2 mg/kg/day of methylprednisolone or prednisone for at least three days or recurrence of acute GVHD as corticosteroids are tapered from initial treatment of the initial episode of GVHD
- Evidence of engraftment (ANC over 1000 cells/mm3)
- Histologic evidence of GVHD from biopsy performed during the current episode
- Received GVHD prophylaxis of methotrexate, tacrolimus or cyclosporine
Show all 9Show fewer
- Age at least 18 years
- Body weight under 130 kg
- Both males and females are eligible but females of childbearing potential will use an accepted method of avoiding pregnancy for at least 60 days after the end of treatment (which includes oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or a sterile sexual partner)
Who cannot join
- Previous receipt of MEDI-507
- Clinical or histologic manifestation of chronic GVHD
- Previous treatment with any anti-T-cell antibodies such as OKT®3 or daclizumab (Zenapax®)
- Receipt of antithymocyte globulin (ATGAM® or other ATG) since the day of transplant
- More than one allogeneic bone marrow or hematopoietic stem cell allograft
- Moribund and unlikely (in the opinion of the investigator) to survive 15 days
Show all 11Show fewer
- Use of other investigational agents within 30 days (this does not include the use of licensed agents for indications not listed in the package insert)
- Any of the following clinical settings or diagnoses:
- Ø documented or presumed significant active infection Ø pregnancy or nursing mother Ø evidence of infection with HIV-1, hepatitis B or C virus Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator
- Histologically confirmed veno-occlusive disease of the liver
- Ascites on physical examination (this does not include small amounts of ascitic fluid detected only on ultrasound)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Baylor University Medical Center
Dallas, Texas, 75246
University of Colorado Health Sciences Center
Denver, Colorado, 80262
City of Hope National Medical Center
Duarte, California, 91010
M.D. Anderson Cancer Center
Houston, Texas, 77030
University Hospital-University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Western Pennsylvania Hospital - Western Pennsylvania Cancer Center
Pittsburgh, Pennsylvania, 15224
South Texas Cancer Institute at Methodist Hospital
San Antonio, Texas, 78229
Washington University Medical Center
St Louis, Missouri, 63110
About this study
Official title: Phase I Study of MEDI-507 in the Treatment of Adult Patients With at Least Grade II Steroid-Resistant Acute Graft-Versus-Host Disease
A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.
Read the detailed description
To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow allograft recipients who have at least grade II acute GVHD and who have not achieved a satisfactory response to at least three days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or its equivalent).
- Conditions
- Cancer, Graft-Versus-Host Disease
- Being tested
- MEDI-507
- Medical subject headings
- Neoplasms, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-507Drug
0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37.
MEDI-507Drug
0.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of MEDI-507 on Days 16, 23, 30, and 37.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
| 2 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs.
Measured: Day 0-60
Secondary outcomes (1)
Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics
Measured: Study Days 12 and 44
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startMay 1998
- Primary completionNov 1998
- Study completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J. Bruce McClain, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806728
- Sponsor's protocol ID
- MI-CP042
- Status last verified
- Dec 2008
- First submitted
- 10 Dec 2008
- Last updated
- 11 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of MEDI-507 in the Treatment of Adult Patients With at Least Grade II Steroid-Resistant Acute Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT00806728
- Acronym / sponsor ID
- MI-CP042
- Conditions
- Cancer, Graft-Versus-Host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- May 1998
- Primary completion
- Nov 1998 (actual)
- Study completion
- Dec 1998 (actual)
- First posted
- 11 Dec 2008 (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.
A clinical trial to assess safety and two regimens of (MEDI-507) a drug given to stem cell and bone marrow recipients who have a mid-grade acute Graft-versus-Host Disease.
Detailed description
To assess the safety of two regimens of MEDI-507 administered to stem cell and bone marrow allograft recipients who have at least grade II acute GVHD and who have not achieved a satisfactory response to at least three days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or its equivalent).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-507MEDI-507 |
| 2 | Experimental | Drug: MEDI-507MEDI-507 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Allogeneic bone marrow or hematopoietic stem cell graft recipients
- Acute GVHD of at least grade II severity
- Failure of GVHD to improve on at least 2 mg/kg/day of methylprednisolone or prednisone for at least three days or recurrence of acute GVHD as corticosteroids are tapered from initial treatment of the initial episode of GVHD
- Evidence of engraftment (ANC over 1000 cells/mm3)
- Histologic evidence of GVHD from biopsy performed during the current episode
Key exclusion criteria (11 listed)
- Previous receipt of MEDI-507
- Clinical or histologic manifestation of chronic GVHD
- Previous treatment with any anti-T-cell antibodies such as OKT®3 or daclizumab (Zenapax®)
- Receipt of antithymocyte globulin (ATGAM® or other ATG) since the day of transplant
- More than one allogeneic bone marrow or hematopoietic stem cell allograft
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-5070.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of normal saline on Days 16, 23, 30, and 37. | Drug | 1 |
| MEDI-5070.12 mg/kg of MEDI-507 given every third day for 4 doses followed by doses of MEDI-507 on Days 16, 23, 30, and 37. | Drug | 2 |
Primary outcome
Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs.
Time frame: Day 0-60
1 secondary outcome
Pharmacokinetics, Lymphocyte Phenotype and CD2 Receptor Occupancy Pharmacodynamics
Time frame: Study Days 12 and 44
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 11 Dec 2008.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
J. Bruce McClain, M.D. study director
MedImmune LLC
10 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 Cancer and Graft-Versus-Host Disease, run by MedImmune LLC at 10 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 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 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 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?
Safety was assessed by the direct observation of patients, medical history, and clinical laboratory evaluation to determine the incidence of patients experiencing AEs. (time frame: Day 0-60). 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 11 Dec 2008; AzTrials last refreshed its copy on 7 Nov 2026.