Hodgkin DiseasePhase 1/2NCT00051597
A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
A Phase 1/2 study testing SGN-30 (monoclonal antibody) in people with Hodgkin Disease and Lymphoma, Large-Cell, run by Seagen Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Disease, Lymphoma, Large-Cell, Sarcoma, Kaposi
- What is being tested?
- SGN-30 (monoclonal antibody)
- How many people
- 70 participants
- Where
- 10 sitesUnited States
- Study dates
- Start not givento Aug 2003
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed CD30+ hematologic malignancy. Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease.
- Patients must have at least one of the following:
- Patients with HD must have failed systemic chemotherapy either as initial therapy for advanced stage disease or as salvage therapy after initial radiotherapy (XRT) for early stage disease and be ineligible for, or refuse treatment by stem cell transplantation
- Patients with other CD30+ malignancies must be beyond 1st remission or refractory to front line chemotherapy
- Patients with refractory or chemo-resistant multiple myeloma (MM), as defined by a failure to respond (<50% reduction in M-protein level), or disease progression less than 2 months after receiving at least two conventional chemotherapy regimens
- Patients with MM in the Plateau Phase of their disease may be included in the study. Plateau phase will be defined as persistent (more than 6 weeks) M-protein in the serum or urine despite a significant initial reduction (>50%) in response to previous therapy. These patients should have received at least two of the conventional chemotherapy regimens listed above prior to enrollment in this study.
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- Patients with relapsed MM as defined by disease progression more than 2 months after initial therapy and subsequent failure to respond (<50% reduction or progression in M-protein levels) to ONE of the above listed regimens or other salvage regimens (high dose cyclophosphamide, topotecan).
- Patients must have at least one of the following:
- Bidimensional or unidimensional measurable disease on physical examination or radiologic evaluation
- Circulating tumor cells in peripheral blood
- Evidence of bone marrow disease to any degree in patients with HD
- >10% tumor cells in bone marrow in patients with other CD30+ malignancies
- Minimum of 4 weeks from last therapy (including radiotherapy or chemotherapy); a minimum of 6 weeks from last treatment with nitrogen mustard agents, melphalan or BCNU
- ECOG performance status ≤ 2 (Appendix B) with a life expectancy > 3 months
Who cannot join
- A diagnosis of Cutaneous T-Cell Lymphoma (CTCL) or non-secretory MM
- Symptomatic cardiac disease including ventricular dysfunction, coronary artery disease or arrhythmias
- More than one primary malignancy with the exception of non-melanoma skin cancer or cervical carcinoma in situ (CIN) on a biopsy or squamous intraepithelial lesion (SIL) on PAP smear
- Active viral, bacterial, or systemic fungal infection including known HIV positivity
- Symptomatic brain metastases requiring treatment
- Concurrent therapy with other anti-neoplastic agents, corticosteroids, or experimental agents
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- Any serious underlying medical condition which would impair the ability of the patient to receive or tolerate the planned treatment including prior allergic reactions to recombinant human or murine proteins
- Receipt of any therapeutic mAbs within 6 months unless a recent serum testing reveals no antibody titer and no evidence of anti-chimeric or anti-murine antibody in the peripheral circulation
- Female patients who are pregnant or breastfeeding
- Dementia or altered mental status that would prohibit the understanding and rendering of informed consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
MD Anderson Cancer Center
Houston, Texas, 77030
USC Norris Cancer Center
Los Angeles, California, 90033
University of Miami
Miami, Florida, 33136
Cornell Medical College, New York Presbyterian
New York, New York, 10021
University of Nebraska
Omaha, Nebraska, 68198
University of Rochester
Rochester, New York, 14642
University of Washington
Seattle, Washington, 98109
Siteman Cancer Center
St Louis, Missouri, 63110
About this study
Official title: A Phase I/II Multi-Dose Study of SGN-30 in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic malignancies.
This is a single-arm, open-label phase I/II study designed to define the toxicity profile, pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics (TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose (MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.
- Conditions
- Hodgkin Disease, Lymphoma, Large-Cell, Sarcoma, Kaposi, Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell
- Being tested
- SGN-30 (monoclonal antibody)
- Medical subject headings
- Hodgkin Disease, Dendritic Cell Sarcoma, Interdigitating, Sarcoma, Kaposi, Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-30 (monoclonal antibody)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2003 (estimated)
- Study completionAug 2003
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 Hodgkin DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amy P Sing, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051597
- Sponsor's protocol ID
- SG030-0002
- Status last verified
- Oct 2011
- First submitted
- 13 Jan 2003
- Last updated
- 12 Oct 2011
- Results posted
- No
Publications
Bartlett NL, Younes A, Carabasi MH, Forero A, Rosenblatt JD, Leonard JP, Bernstein SH, Bociek RG, Lorenz JM, Hart BW, Barton J. A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Blood. 2008 Feb 15;111(4):1848-54. doi: 10.1182/blood-2007-07-099317. Epub 2007 Dec 13.
PubMed 18079362
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Multi-Dose Study of SGN-30 in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00051597
- Acronym / sponsor ID
- SG030-0002
- Conditions
- Hodgkin Disease, Lymphoma, Large-Cell, Sarcoma, Kaposi, Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study completion
- Aug 2003 (actual)
- First posted
- 15 Jan 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.
The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic malignancies.
This is a single-arm, open-label phase I/II study designed to define the toxicity profile, pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics (TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose (MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.
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)
- Histologically confirmed CD30+ hematologic malignancy. Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease.
- Patients with HD must have failed systemic chemotherapy either as initial therapy for advanced stage disease or as salvage therapy after initial radiotherapy (XRT) for early stage disease and be ineligible for, or refuse treatment by stem cell transplantation
- Patients with other CD30+ malignancies must be beyond 1st remission or refractory to front line chemotherapy
- Patients with refractory or chemo-resistant multiple myeloma (MM), as defined by a failure to respond (<50% reduction in M-protein level), or disease progression less than 2 months after receiving at least two conventional chemotherapy regimens
- Patients with MM in the Plateau Phase of their disease may be included in the study. Plateau phase will be defined as persistent (more than 6 weeks) M-protein in the serum or urine despite a significant initial reduction (>50%) in response to previous therapy. These patients should have received at least two of the conventional chemotherapy regimens listed above prior to enrollment in this study.
Key exclusion criteria (10 listed)
- A diagnosis of Cutaneous T-Cell Lymphoma (CTCL) or non-secretory MM
- Symptomatic cardiac disease including ventricular dysfunction, coronary artery disease or arrhythmias
- More than one primary malignancy with the exception of non-melanoma skin cancer or cervical carcinoma in situ (CIN) on a biopsy or squamous intraepithelial lesion (SIL) on PAP smear
- Active viral, bacterial, or systemic fungal infection including known HIV positivity
- Symptomatic brain metastases requiring treatment
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 (monoclonal antibody) | 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 12 Oct 2011.
- Derived from this study: PubMed 18079362Bartlett NL, Younes A, Carabasi MH, Forero A, Rosenblatt JD, Leonard JP, Bernstein SH, Bociek RG, Lorenz JM, Hart BW, Barton J. A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Blood. 2008 Feb 15;111(4):1848-54. doi: 10.1182/blood-2007-07-099317. Epub 2007 Dec 13.
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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.
Amy P Sing, MD study director
Seagen Inc.
10 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 SGN-30 (monoclonal antibody) in people with Hodgkin Disease and Lymphoma, Large-Cell, run by Seagen Inc. 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 14 inclusion and 10 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 2011. 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 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 NCT00051597, 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 12 Oct 2011.