LymphomaPhase 1/2NCT00059995
MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
A Phase 1/2 study testing iratumumab in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- iratumumab
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Jan 2003to Nov 2009
- Phase
- Phase 1/2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed B-cell or T-cell lymphoma
- Hodgkin's lymphoma and anaplastic large cell lymphoma eligible
- No HIV-associated lymphoma
- CD30-positive disease by biopsy, flow cytometry, or immunohistochemistry
- At least 50% of malignant cells (specifically Reed-Sternberg cells for Hodgkin's lymphoma) must express CD30
- Must meet one of the following criteria for relapsed/refractory disease:
- Relapsed after prior chemotherapy or radiotherapy and autologous or allogeneic bone marrow transplantation (if appropriate)
- Relapsed disease must be within the prior irradiated field
- Disease that is refractory to prior chemotherapy or radiotherapy with no other curative treatment option
- Disease progression must be within the prior irradiated field
- Progressive and evaluable disease (measurable disease required for patients accrued on study after the maximum tolerated dose is determined)
PATIENT CHARACTERISTICS:
Age
- Over 12
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- WBC at least 1,500/mm^3*
- Neutrophil count at least 1,000/mm^3*
- Platelet count at least 75,000/mm^3*
- Hemoglobin at least 8.0 g/dL* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Hepatic
- AST no greater than 2 times upper limit of normal (ULN)*
- Bilirubin no greater than 2.0 mg/dL (unless due to Gilbert's syndrome)*
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Renal
- Creatinine no greater than 2 times ULN* NOTE: *Laboratory abnormalities attributable to organ involvement by lymphoma are allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 9 months after study participation
- HIV negative
- No other active malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No active significant infection
- No apparent opportunistic infection, as indicated by any of the following:
- Purified protein derivative recently determined to be positive
- Infectious infiltrate by chest x-ray
- Recent changes in fever/chill patterns
- New, unexplained neurological symptoms
- No underlying medical condition that would preclude receiving study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior anti-CD30 antibody therapy
- No other concurrent biologic therapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- No concurrent systemic steroidal therapy (excluding physiologic doses)
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No other concurrent investigational agents
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210-1240
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma
RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma.
- Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks.
Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD.
Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- iratumumab
- Keywords
- recurrent adult Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma, anaplastic large cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent childhood large cell lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease, Recurrence, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Large B-Cell, Diffuse, Dendritic Cell Sarcoma, Interdigitating, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iratumumabBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startJan 2003
- Primary completionOct 2007
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1/2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven M. Horwitz, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059995
- Sponsor's protocol ID
- MDX-060-01
- Other IDs
- MSKCC-02121, CDR0000298995
- Status last verified
- Nov 2009
- First submitted
- 6 May 2003
- Last updated
- 30 May 2013
- Results posted
- No
Publications
Ansell SM, Horwitz SM, Engert A, Khan KD, Lin T, Strair R, Keler T, Graziano R, Blanset D, Yellin M, Fischkoff S, Assad A, Borchmann P. Phase I/II study of an anti-CD30 monoclonal antibody (MDX-060) in Hodgkin's lymphoma and anaplastic large-cell lymphoma. J Clin Oncol. 2007 Jul 1;25(19):2764-9. doi: 10.1200/JCO.2006.07.8972. Epub 2007 May 21.
PubMed 17515574
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Open Label, Dose-Escalating Study of MDX-060 Administered Weekly for 4 Weeks in Patients With Refractory/Relapsed CD30 Lymphoma
- ClinicalTrials.gov ID
- NCT00059995
- Acronym / sponsor ID
- MDX-060-01
- Conditions
- Lymphoma
- Keywords
- recurrent adult Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma, anaplastic large cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent childhood large cell lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 May 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.
RATIONALE: Monoclonal antibodies such as MDX-060 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of MDX-060 monoclonal antibody in treating patients who have refractory or relapsed lymphoma.
Detailed description
OBJECTIVES:
- Determine the safety and tolerability of MDX-060 monoclonal antibody in patients with refractory or relapsed CD30-positive lymphoma.
- Determine the maximum tolerated dose and dose-limiting toxicity of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, the efficacy (antilymphoma activity) of this drug in these patients.
OUTLINE: This is an open-label, multicenter, dose-escalation study.
Patients receive MDX-060 monoclonal antibody IV over 90 minutes once weekly for 4 weeks.
Cohorts of 3-6 patients receive escalating doses of MDX-060 monoclonal antibody until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 16 patients are accrued and receive MDX-060 monoclonal antibody at the MTD.
Patients are followed monthly for 3 months and then every 3 months for 18 months or until disease progression.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| iratumumab | Biological | – |
Primary outcome
Not reported in the source record.
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 30 May 2013.
- Results publication: PubMed 17515574Ansell SM, Horwitz SM, Engert A, Khan KD, Lin T, Strair R, Keler T, Graziano R, Blanset D, Yellin M, Fischkoff S, Assad A, Borchmann P. Phase I/II study of an anti-CD30 monoclonal antibody (MDX-060) in Hodgkin's lymphoma and anaplastic large-cell lymphoma. J Clin Oncol. 2007 Jul 1;25(19):2764-9. doi: 10.1200/JCO.2006.07.8972. Epub 2007 May 21.
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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.
Steven M. Horwitz, MD study chair
Memorial Sloan Kettering Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing iratumumab in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 3 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: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059995, which also lists 1 linked publication.
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 30 May 2013.