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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00099255

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Large Cell Lymphoma	Drug: SGN-30	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

To determine the objective response rate in patients with pcALCL, T-MF, and LyP []
To determine the duration of response in patients treated with SGN-30 []
To investigate the toxicity profile of SGN-30 []

Secondary Outcome Measures

To provide preliminary estimates of disease-free and overall survival rates in pcALCL and T-MF patients treated with SGN-30 []
To determine the immunogenicity of SGN-30 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of California at Los Angeles	Los Angeles	California	United States	90095
3	Stanford University	Stanford	California	United States	94305
4	Yale	New Haven	Connecticut	United States	06520
5	Northwestern Universtiy	Chicago	Illinois	United States	60611
6	University of Illinois at Chicago	Chicago	Illinois	United States	60612
7	Johns Hopkins	Baltimore	Maryland	United States	21827
8	University of Minnesota	Minneapolis	Minnesota	United States	55455
9	Memorial Sloan-Kettering	New York	New York	United States	10021
10	Cleveland University	Cleveland	Ohio	United States	44106
11	Kaiser Permanente - Oncology Research	Portland	Oregon	United States	97227
12	Vanderbilt University	Nashville	Tennessee	United States	37232
13	MD Anderson Cancer Center	Houston	Texas	United States	77030