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

Lymphoma, B-Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051597
• Other study ID #: SG030-0002
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 13, 2003
• Last updated: October 7, 2011
• Est. completion date: August 2003

Study information

• Verified date: October 2011
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• 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

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large-Cell
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Sarcoma, Kaposi

Intervention

Drug:
• SGN-30 (monoclonal antibody)

Locations

Country	Name	City	State
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	MD Anderson Cancer Center	Houston	Texas
United States	USC Norris Cancer Center	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Cornell Medical College, New York Presbyterian	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	University of Rochester	Rochester	New York
United States	University of Washington	Seattle	Washington
United States	Siteman Cancer Center	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States,