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Large Cell LymphomaPhase 2NCT00099255

Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma

A Phase 2 study testing SGN-30 in people with Large Cell Lymphoma, run by Seagen Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multi-center, phase II study will be conducted to define the toxicity profile and antitumor activity of SGN-30 in patients with pcALCL and other closely related lymphoproliferative disorders. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Large Cell Lymphoma
What is being tested?
SGN-30
How many people
40 participants
Where
13 sitesUnited States
Study dates
Sep 2004to Feb 2007
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 a definite diagnosis.
  • Patients must be histologically confirmed CD30 positive within 3 months of enrollment
  • Patients with pcALCL must have target lesions present for at least 1 month without spontaneous regression
  • pcALCL patients must have failed treatment with local radiation therapy, or failed systemic therapy of a single agent
  • Patients must be considered an eligible candidate for systemic therapy as determined by the investigator
  • All patients must have a three week wash-out from previous treatments, unless in the opinion of the investigator it is not in the best interest of the patient, at which point the individual case must be discussed with the medical monitor prior to enrollment.
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  • Patients must have an ECOG performance status of < 2 (Appendix B) and a life expectancy > six 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 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.
  • Required baseline laboratory data: Absolute neutrophil count greater than or equal to to 1,000/mm3, Platelet count greater than or equal to 75,000/mm3, Serum bilirubin less than or equal to 1.5 times ULN, Serum creatinine less than or equal to 1.5 times ULN, BUN less than or equal to 1.5 times ULN, SGOT less than or equal to 2.5 ULN, SGPT less than or equal to 2.5 ULN
  • Criteria for Exclusion
  • Patients with Sezary syndrome, or any type of lymphoproliferative disease other than pcALCL, T-MF or LyP
  • Patients with systemic ALCL or extracutaneous involvement of cutaneous ALCL
  • Patients with known active systemic viral, bacterial, or fungal infection
  • Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive
  • Patients who have been treated previously with any anti-CD30 antibody
  • 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
  • Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias
  • 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

Who cannot join

None listed.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Johns Hopkins

    Baltimore, Maryland, 21827

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Northwestern Universtiy

    Chicago, Illinois, 60611

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Cleveland University

    Cleveland, Ohio, 44106

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California at Los Angeles

    Los Angeles, California, 90095

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Yale

    New Haven, Connecticut, 06520

  • Memorial Sloan-Kettering

    New York, New York, 10021

  • Kaiser Permanente - Oncology Research

    Portland, Oregon, 97227

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma, Large Cell Transformation of Mycosis Fungoides, and Lymphomatoid Papulosis

This multi-center, phase II study will be conducted to define the toxicity profile and antitumor activity of SGN-30 in patients with pcALCL and other closely related lymphoproliferative disorders.

Being tested
SGN-30
Keywords
Keyword?, Primary Cutaneous Anaplastic Large Cell Lymphoma, Large Cell Transformation of Mycosis Fungoides, Lymphomatoid Papulosis
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Primary Cutaneous Anaplastic Large Cell, Lymphomatoid Papulosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGN-30Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the objective response rate in patients with pcALCL, T-MF, and LyP

  2. To determine the duration of response in patients treated with SGN-30

  3. To investigate the toxicity profile of SGN-30

Secondary outcomes (2)

  1. To provide preliminary estimates of disease-free and overall survival rates in pcALCL and T-MF patients treated with SGN-30

  2. To determine the immunogenicity of SGN-30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

Resources

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
Crossover
Masking
None (open label)
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00099255
Sponsor's protocol ID
SG030-0004
Status last verified
Dec 2014
First submitted
10 Dec 2004
Last updated
18 Dec 2014
Results posted
No

Publications

  • Duvic M, Reddy SA, Pinter-Brown L, Korman NJ, Zic J, Kennedy DA, Lorenz J, Sievers EL, Kim YH. A phase II study of SGN-30 in cutaneous anaplastic large cell lymphoma and related lymphoproliferative disorders. Clin Cancer Res. 2009 Oct 1;15(19):6217-24. doi: 10.1158/1078-0432.CCR-09-0162. Epub 2009 Sep 29.

    PubMed 19789316

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SGN-30 in people with Large Cell Lymphoma, run by Seagen Inc. at 13 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 24 inclusion and 0 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 13 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.

What does the primary outcome measure?

To determine the objective response rate in patients with pcALCL, T-MF, and LyP. 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?

On the ClinicalTrials.gov record for NCT00099255, 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 18 Dec 2014.

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