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A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies

A Phase I/II Multi-Dose Study of SGN-30 in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies

NCT00051597•Seagen Inc.

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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
+4 more criteria

Exclusion Criteria

•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
•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

Locations (10)

University of Alabama, Birmingham

Birmingham, Alabama, United States

USC Norris Cancer Center

Los Angeles, California, United States

University of Miami

Miami, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Siteman Cancer Center

St Louis, Missouri, United States

University of Nebraska

Omaha, Nebraska, United States

Cornell Medical College, New York Presbyterian

New York, New York, United States

University of Rochester

Rochester, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Key Dates

Completion Date

August 1, 2003

Last Updated

October 12, 2011

Enrollment

Estimated participants

Conditions

Hodgkin DiseaseLymphoma, Large-CellSarcoma, KaposiLymphoma, T-Cell, CutaneousLymphoma, B-Cell

Interventions

SGN-30 (monoclonal antibody)

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ACTIVE_NOT_RECRUITINGPHASE1

Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies

Inclusion Criteria

Exclusion Criteria

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