NCT00051597

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

First QC Date

January 13, 2003

Last Update Submit

October 7, 2011

Conditions

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

Interventions

SGN-30 (monoclonal antibody)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

USC Norris Cancer Center

Los Angeles, California, 90033, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

Cornell Medical College, New York Presbyterian

New York, New York, 10021, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • 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.

    PMID: 18079362DERIVED

MeSH Terms

Conditions

Hodgkin DiseaseDendritic Cell Sarcoma, InterdigitatingSarcoma, KaposiLymphoma, T-Cell, CutaneousLymphoma, B-Cell

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHistiocytic Disorders, MalignantHistiocytosisHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms, Vascular TissueLymphoma, T-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

OligopeptidesPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Amy P Sing, MD

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2003

First Posted

January 15, 2003

Study Completion

August 1, 2003

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations

US(10)