Anaplastic Large-Cell LymphomaPhase 2NCT00079755
Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent Anaplastic Large Cell Lymphoma
A Phase 2 study testing SGN-30 (anti-CD30 mAb) in people with Anaplastic Large-Cell Lymphoma, run by Seagen Inc. at 18 sites in United States.
Trial summary
To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's Disease and anaplastic large cell lymphoma (ALCL). As of March 22, 2005, interim analysis of the Hodgkin's Disease (HD) arm has been completed per the statistical plan in the protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Large-Cell Lymphoma
- What is being tested?
- SGN-30 (anti-CD30 mAb)
- How many people
- 80 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 2004to Dec 2006
- 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 have refractory or recurrent HD or refractory or recurrent ALCL.
- Patients must have histologically confirmed CD30+ HD or ALCL.
- Patients must have bidimensional measurable disease on physical examination or radiologic evaluation.
- Patients must have failed systemic chemotherapy either as initial therapy for advanced disease or as salvage therapy after initial radiotherapy for early stage disease.
- Patients may have received no more than four treatments (radiation, chemotherapy, and/or biologics) prior to enrollment.
- Patients may have received no more than one stem cell transplantation.
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- Patients who have undergone stem cell transplantation must have received at least one therapy post-transplantation. Patients who have not had stem cell transplantation must be considered ineligible or refuse treatment by stem cell transplantation.
- Patients must have completed radiotherapy and/or chemotherapy at least four weeks prior to enrollment. Any prior treatment with nitrogen mustard agents, melphalan, or BCNU must have been completed at least six weeks prior to enrollment.
- Patients must have an ECOG performance status of ≤ 2 and a life expectancy > three months.
- Patients must be at least 18 years of age.
- Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
- Females of childbearing potential must have a negative β-HCG pregnancy test result within three days of enrollment. All patients must agree to use an effective contraceptive method during the course of the study.
- Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart.
- Patients must meet baseline lab data requirements.
Who cannot join
- Patients with primary cutaneous ALCL
- Patients who have been treated previously with any anti-CD30 antibody
- Patients who have received any mAb unless a recent serum testing reveals no antibody titer and no evidence of human anti-murine antibodies (HAMA) or human anti-chimeric antibodies (HACA) in the peripheral circulation
- Patients receiving any investigational biological agent within eight weeks of enrollment or any other investigational agent within four weeks of enrollment
- Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
- Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ
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- Patients with known active viral, bacterial, or systemic fungal infection; patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
- Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias
- Patients with symptomatic brain metastases requiring treatment
- Patients who are pregnant or breastfeeding
- Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment
- Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
University of Alabama, Birmingham
Birmingham, Alabama, 35294-3300
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263
Northwestern University
Chicago, Illinois, 60611
Duke University Medical Center
Durham, North Carolina, 27710
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Califorinia at Los Angeles
Los Angeles, California, 91342
University of Miami
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55455
Cornell University
New York, New York, 10021
University of Nebraska
Omaha, Nebraska, 68198-7680
Kaiser Permanente
Portland, Oregon, 97227
Oregon Health Science University
Portland, Oregon, 97239
University of Rochester
Rochester, New York, 14642
University of Washington
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Refractory or Recurrent Hodgkin's Disease or Anaplastic Large Cell Lymphoma
To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's Disease and anaplastic large cell lymphoma (ALCL).
As of March 22, 2005, interim analysis of the Hodgkin's Disease (HD) arm has been completed per the statistical plan in the protocol. SG030-0003 is now closed to further recruitment of HD patients.
Read the detailed description
SGN-30 is the chimeric form of a novel murine monoclonal antibody (mAb), AC-10, that has specificity for CD30. The CD30 antigen has a very low expression on normal cells, but is expressed on malignant cells in Hodgkins disease and anaplastic large cell lymphoma.
This study is designed to define the toxicity profile and antitumor activity of SGN-30 in patients with refractory or recurrent Hodgkin's disease and with refractory or recurrent anaplastic large cell lymphoma. Patients will receive 6 weekly intravenous (IV) infusions of SGN-30 followed by a 4 week observation period.
- Conditions
- Anaplastic Large-Cell Lymphoma
- Being tested
- SGN-30 (anti-CD30 mAb)
- Keywords
- Anaplastic Large-Cell Lymphoma, Lymphoma, antigens, CD30, Monoclonal Antibody
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-30 (anti-CD30 mAb)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2004 (estimated)
- Study startFeb 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anaplastic Large-Cell 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079755
- Sponsor's protocol ID
- SG030-0003
- Status last verified
- Dec 2014
- First submitted
- 12 Mar 2004
- Last updated
- 18 Dec 2014
- Results posted
- No
Publications
Wahl AF, Klussman K, Thompson JD, Chen JH, Francisco LV, Risdon G, Chace DF, Siegall CB, Francisco JA. The anti-CD30 monoclonal antibody SGN-30 promotes growth arrest and DNA fragmentation in vitro and affects antitumor activity in models of Hodgkin's disease. Cancer Res. 2002 Jul 1;62(13):3736-42.
PubMed 12097283Forero-Torres A, Leonard JP, Younes A, Rosenblatt JD, Brice P, Bartlett NL, Bosly A, Pinter-Brown L, Kennedy D, Sievers EL, Gopal AK. A Phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma or systemic anaplastic large cell lymphoma. Br J Haematol. 2009 Jul;146(2):171-9. doi: 10.1111/j.1365-2141.2009.07740.x. Epub 2009 May 19.
PubMed 19466965
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Refractory or Recurrent Hodgkin's Disease or Anaplastic Large Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00079755
- Acronym / sponsor ID
- SG030-0003
- Conditions
- Anaplastic Large-Cell Lymphoma
- Keywords
- Anaplastic Large-Cell Lymphoma, Lymphoma, antigens, CD30, Monoclonal Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 16 Mar 2004 (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.
To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's Disease and anaplastic large cell lymphoma (ALCL).
As of March 22, 2005, interim analysis of the Hodgkin's Disease (HD) arm has been completed per the statistical plan in the protocol. SG030-0003 is now closed to further recruitment of HD patients.
Detailed description
SGN-30 is the chimeric form of a novel murine monoclonal antibody (mAb), AC-10, that has specificity for CD30. The CD30 antigen has a very low expression on normal cells, but is expressed on malignant cells in Hodgkins disease and anaplastic large cell lymphoma.
This study is designed to define the toxicity profile and antitumor activity of SGN-30 in patients with refractory or recurrent Hodgkin's disease and with refractory or recurrent anaplastic large cell lymphoma. Patients will receive 6 weekly intravenous (IV) infusions of SGN-30 followed by a 4 week observation period.
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
Key inclusion criteria (14 listed)
- Patients must have refractory or recurrent HD or refractory or recurrent ALCL.
- Patients must have histologically confirmed CD30+ HD or ALCL.
- Patients must have bidimensional measurable disease on physical examination or radiologic evaluation.
- Patients must have failed systemic chemotherapy either as initial therapy for advanced disease or as salvage therapy after initial radiotherapy for early stage disease.
- Patients may have received no more than four treatments (radiation, chemotherapy, and/or biologics) prior to enrollment.
Key exclusion criteria (12 listed)
- Patients with primary cutaneous ALCL
- Patients who have been treated previously with any anti-CD30 antibody
- Patients who have received any mAb unless a recent serum testing reveals no antibody titer and no evidence of human anti-murine antibodies (HAMA) or human anti-chimeric antibodies (HACA) in the peripheral circulation
- Patients receiving any investigational biological agent within eight weeks of enrollment or any other investigational agent within four weeks of enrollment
- Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
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 |
|---|---|---|
| SGN-30 (anti-CD30 mAb) | Drug | – |
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 18 Dec 2014.
- Results publication: PubMed 12097283Wahl AF, Klussman K, Thompson JD, Chen JH, Francisco LV, Risdon G, Chace DF, Siegall CB, Francisco JA. The anti-CD30 monoclonal antibody SGN-30 promotes growth arrest and DNA fragmentation in vitro and affects antitumor activity in models of Hodgkin's disease. Cancer Res. 2002 Jul 1;62(13):3736-42.
- Results publication: PubMed 19466965Forero-Torres A, Leonard JP, Younes A, Rosenblatt JD, Brice P, Bartlett NL, Bosly A, Pinter-Brown L, Kennedy D, Sievers EL, Gopal AK. A Phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma or systemic anaplastic large cell lymphoma. Br J Haematol. 2009 Jul;146(2):171-9. doi: 10.1111/j.1365-2141.2009.07740.x. Epub 2009 May 19.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 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 SGN-30 (anti-CD30 mAb) in people with Anaplastic Large-Cell Lymphoma, run by Seagen Inc. at 18 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 14 inclusion and 12 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00079755, which also lists 2 linked publications.
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 18 Dec 2014.