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SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00365274
Recruitment Status : Terminated
First Posted : August 17, 2006
Results First Posted : November 18, 2013
Last Update Posted : June 2, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anaplastic Large Cell Lymphoma
Interventions Drug: Cyclophosphamide
Drug: Doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Drug: SGN-30
Enrollment 6
Recruitment Details Recruitment Period: August 9, 2006 to February 26, 2009. All recruitment was done in medical clinics.
Pre-assignment Details The six participants were registered at UT MD Anderson Cancer Center prior to early study termination although recruitment was open to multi-centers.
Arm/Group Title SGN-30 + Combination Chemotherapy
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Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.

SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title SGN-30 + Combination Chemotherapy
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Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.

SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
36
(20 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description Objective response rate (ORR) defined as the proportion of participants experiencing a Complete Response (CR) or Partial Response to a regimen of SGN-3- + CHOP using International Workshop Response Criteria (IWG) for Non-Hodgkin's Lymphomas (NHL). The IWG criteria (Cheson et al 2007) for a CR is a complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A PR is at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase should be observed in the size of other nodes, liver or spleen, and no new sites of disease should be observed.
Time Frame Up to 5 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title SGN-30 + Combination Chemotherapy
Hide Arm/Group Description:

Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.

SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.

Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response 83
Partial Response 17
Time Frame 2 years and 11 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SGN-30 + Combination Chemotherapy
Hide Arm/Group Description

Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.

SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses.

All-Cause Mortality
SGN-30 + Combination Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SGN-30 + Combination Chemotherapy
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SGN-30 + Combination Chemotherapy
Affected / at Risk (%)
Total   5/6 (83.33%) 
Blood and lymphatic system disorders   
Elevated ALT, SGPT  1 [1]  1/6 (16.67%) 
Elevated Bilirubin  1  1/6 (16.67%) 
Elevated Hemoglobin  1  1/6 (16.67%) 
Hyperglycemia  1  2/6 (33.33%) 
Hypoglycemia  1  1/6 (16.67%) 
Elevated Leukocytes  1  3/6 (50.00%) 
Elevated Neutrophils (ANC/AGC)  1 [2]  2/6 (33.33%) 
Elevated Platelets  1  1/6 (16.67%) 
Eye disorders   
Blurred Vision  1  2/6 (33.33%) 
Ocular/visual (other)  1  1/6 (16.67%) 
Watery Eye  1  2/6 (33.33%) 
Gastrointestinal disorders   
Constipation  1  2/6 (33.33%) 
Diarrhea  1  3/6 (50.00%) 
Dry Mouth  1  1/6 (16.67%) 
Nausea  1  2/6 (33.33%) 
Vomiting  1  2/6 (33.33%) 
General disorders   
Fatigue  1  3/6 (50.00%) 
Infections and infestations   
Fever without neutropenia  1  2/6 (33.33%) 
Investigations   
Edema: head and neck  1  1/6 (16.67%) 
Rigors/chills  1  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Pain  1 [3]  4/6 (66.67%) 
Nervous system disorders   
Dizziness  1  2/6 (33.33%) 
Neuropathy: motor  1  1/6 (16.67%) 
Neuropathy: sensory  1  2/6 (33.33%) 
Psychiatric disorders   
Insomnia  1  1/6 (16.67%) 
Memory impairment  1  2/6 (33.33%) 
Mood alteration (depression)  1  1/6 (16.67%) 
Reproductive system and breast disorders   
Hot flashes  1  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Allergic Rhinitis  1  1/6 (16.67%) 
Cough  1  1/6 (16.67%) 
Dysphagia  1  1/6 (16.67%) 
Dyspnea  1  2/6 (33.33%) 
Mucositis, oral cavity  1  4/6 (66.67%) 
Skin and subcutaneous tissue disorders   
Dry Skin  1  1/6 (16.67%) 
Pruritus  1  1/6 (16.67%) 
Rash/desquamation  1  1/6 (16.67%) 
Sweating  1  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
alanine aminotransferase (ALT) or serum glutamic-pyruvic transaminase (SGPT)
[2]
Absolute neutrophil count (ANC)/Absolute Granulocyte Count (AGC)
[3]
Back, Bone, Face, Head, Muscle, and Other
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michelle Fanale, MD / Associate Professor
Organization: The University of Texas (UT) MD Anderson Cancer Center
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00365274     History of Changes
Other Study ID Numbers: NCI-2009-00162
2005-0627 ( Other Identifier: UT MD Anderson Cancer Center )
N01CM62202 ( U.S. NIH Grant/Contract )
N01CM17003 ( U.S. NIH Grant/Contract )
First Submitted: August 16, 2006
First Posted: August 17, 2006
Results First Submitted: September 13, 2013
Results First Posted: November 18, 2013
Last Update Posted: June 2, 2014