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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00051597

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Disease Lymphoma, Large-Cell Sarcoma, Kaposi Lymphoma, T-Cell, Cutaneous Lymphoma, B-Cell	Drug: SGN-30 (monoclonal antibody)	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Aug 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama, Birmingham	Birmingham	Alabama	United States	35294
2	USC Norris Cancer Center	Los Angeles	California	United States	90033
3	University of Miami	Miami	Florida	United States	33136
4	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
5	Siteman Cancer Center	St. Louis	Missouri	United States	63110
6	University of Nebraska	Omaha	Nebraska	United States	68198
7	Cornell Medical College, New York Presbyterian	New York	New York	United States	10021
8	University of Rochester	Rochester	New York	United States	14642
9	MD Anderson Cancer Center	Houston	Texas	United States	77030
10	University of Washington	Seattle	Washington	United States	98109