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Trial record 18 of 36 for:    "Viral Infectious Disease" | "Everolimus"

CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00290472
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : February 11, 2014
Last Update Posted : May 23, 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
Conditions B-cell Chronic Lymphocytic Leukemia
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Malignant Neoplasm
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Intervention Drug: temsirolimus
Enrollment 89
Recruitment Details  
Pre-assignment Details One patient never received protocol treatment and was excluded from analysis.
Arm/Group Title Aggressive B-cell Lymphoma Follicular Lymphoma Chronic Lymphocytic Leukemia
Hide Arm/Group Description Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma. Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma. Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
Period Title: Overall Study
Started 32 39 18
Completed 32 39 18
Not Completed 0 0 0
Arm/Group Title Aggressive B-cell Lymphoma Follicular Lymphoma Chronic Lymphocytic Leukemia Total
Hide Arm/Group Description Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma. Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma. Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas. Total of all reporting groups
Overall Number of Baseline Participants 32 39 18 89
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants 39 participants 18 participants 89 participants
67
(30 to 87)
59
(28 to 75)
57
(38 to 82)
61
(28 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 39 participants 18 participants 89 participants
Female
15
  46.9%
15
  38.5%
7
  38.9%
37
  41.6%
Male
17
  53.1%
24
  61.5%
11
  61.1%
52
  58.4%
1.Primary Outcome
Title Objective Overall Response Rate
Hide Description The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aggressive B-cell Lymphoma Follicular Lymphoma Chronic Lymphocytic Leukemia
Hide Arm/Group Description:
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
Overall Number of Participants Analyzed 32 39 18
Measure Type: Number
Unit of Measure: percentage of participants
28.1 53.8 11.1
2.Primary Outcome
Title Duration of Response
Hide Description Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aggressive B-cell Lymphoma Follicular Lymphoma Chronic Lymphocytic Leukemia
Hide Arm/Group Description:
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
Overall Number of Participants Analyzed 9 21 2
Median (95% Confidence Interval)
Unit of Measure: Month
2.4
(2.1 to 28.4)
13.3
(6.2 to 16.5)
NA [1] 
(NA to NA)
[1]
Chronic Lymphocytic Leukemia group had no progression events.
3.Primary Outcome
Title Overall Survival
Hide Description The overall survival was evaluated using the Kaplan-Meier estimator.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aggressive B-cell Lymphoma Follicular Lymphoma Chronic Lymphocytic Leukemia
Hide Arm/Group Description:
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
Overall Number of Participants Analyzed 32 39 18
Median (95% Confidence Interval)
Unit of Measure: Month
7.3
(4.3 to 18.1)
NA [1] 
(NA to NA)
31.5 [2] 
(9.5 to NA)
[1]
The median Overall Survival and the associated 95% CI was not reached.
[2]
The upper limit of the 95% CI interval was undetermined due to the heavy censoring.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Temsirolimus
Hide Arm/Group Description All patients
All-Cause Mortality
Temsirolimus
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Temsirolimus
Affected / at Risk (%)
Total   21/89 (23.60%) 
Cardiac disorders   
Atrial fibrillation  1  1/89 (1.12%) 
Cardiac disorder  1  1/89 (1.12%) 
Gastrointestinal disorders   
Dysphagia, esophagitis, odynophagia  1  1/89 (1.12%) 
Esophagitis  1  1/89 (1.12%) 
Hemorrhage  1  1/89 (1.12%) 
Stomatitis/pharyngitis  1  1/89 (1.12%) 
Oseophagitis NOS  2  1/89 (1.12%) 
General disorders   
Chest pain  1  1/89 (1.12%) 
Death  1  1/89 (1.12%) 
Fatigue  1  1/89 (1.12%) 
Fever  1  2/89 (2.25%) 
Pyrexia  1  1/89 (1.12%) 
Infections and infestations   
Anorectal infection  1  1/89 (1.12%) 
Pneumonia  1  2/89 (2.25%) 
Respiratory tract infection NOS  1  1/89 (1.12%) 
Skin infection  1  2/89 (2.25%) 
Tooth infection  1  1/89 (1.12%) 
Vulvitis  1  1/89 (1.12%) 
Injury, poisoning and procedural complications   
Postoperative hemorrhage  1  1/89 (1.12%) 
Metabolism and nutrition disorders   
Anorexia  2  1/89 (1.12%) 
Dehydration  1  1/89 (1.12%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  2  1/89 (1.12%) 
Renal and urinary disorders   
Renal/Genitourinary-other  1  1/89 (1.12%) 
Urinary retention  1  1/89 (1.12%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/89 (2.25%) 
Hypoxia  1  2/89 (2.25%) 
Pneumonitis  1  4/89 (4.49%) 
Vascular disorders   
Thrombosis/ embolism  1  1/89 (1.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 2.0
2
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Temsirolimus
Affected / at Risk (%)
Total   89/89 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  2  63/89 (70.79%) 
Hemorrhage nasal  2  8/89 (8.99%) 
Leukopenia  2  65/89 (73.03%) 
Lymphopenia  2  42/89 (47.19%) 
Eye disorders   
Eye disorder  2  5/89 (5.62%) 
Eye problem  2  6/89 (6.74%) 
Gastrointestinal disorders   
Abdominal pain  1  13/89 (14.61%) 
Constipation  2  14/89 (15.73%) 
Diarrhea  2  24/89 (26.97%) 
Dry mouth  2  5/89 (5.62%) 
Nausea  1  19/89 (21.35%) 
Oral pain  2  9/89 (10.11%) 
Stomatitis/ pharyngitis  2  29/89 (32.58%) 
Taste alteration  2  8/89 (8.99%) 
Vomiting  2  11/89 (12.36%) 
General disorders   
Chills  2  5/89 (5.62%) 
Death  2  22/89 (24.72%) 
Disease progression  2  8/89 (8.99%) 
Ear, nose and throat examination abnormal  2  25/89 (28.09%) 
Edema  2  29/89 (32.58%) 
Edema : limb  2  6/89 (6.74%) 
Fatigue  2  56/89 (62.92%) 
Fever  2  15/89 (16.85%) 
General symptom  2  5/89 (5.62%) 
Pain - other  2  6/89 (6.74%) 
Pyrexia  2  6/89 (6.74%) 
Sweating  2  6/89 (6.74%) 
Infections and infestations   
Infection  2  21/89 (23.60%) 
Upper respiratory infection  2  5/89 (5.62%) 
Urinary tract infection  2  6/89 (6.74%) 
Investigations   
Alanine aminotransferase increased  2  27/89 (30.34%) 
Aspartate aminotransferase increased  2  34/89 (38.20%) 
Blood alkaline phosphatase intreased  2  23/89 (25.84%) 
Blood creatinine increased  2  9/89 (10.11%) 
CD4 lymphocytes decreased  2  5/89 (5.62%) 
Neutrophil count  2  52/89 (58.43%) 
Platelet count decreased  2  73/89 (82.02%) 
Metabolism and nutrition disorders   
Anorexia  2  22/89 (24.72%) 
Hypercholesterolemia  2  44/89 (49.44%) 
Hyperglycemia  2  50/89 (56.18%) 
Hyperkalemia  2  6/89 (6.74%) 
Hypertriglyceridemia  2  59/89 (66.29%) 
Hypoalbuminemia  2  24/89 (26.97%) 
Hypocalcemia  2  20/89 (22.47%) 
Hypokalemia  2  25/89 (28.09%) 
Hypomagnesemia  2  8/89 (8.99%) 
Hyponatremia  2  12/89 (13.48%) 
Hypophsphatemia  2  19/89 (21.35%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  2  5/89 (5.62%) 
Back pain  2  7/89 (7.87%) 
Bone pain  2  11/89 (12.36%) 
Muscle weakness  2  12/89 (13.48%) 
Myalgia  2  12/89 (13.48%) 
Pain in extremity  2  14/89 (15.73%) 
Nervous system disorders   
Dizziness  2  10/89 (11.24%) 
Headache  2  19/89 (21.35%) 
Memory impairment  2  5/89 (5.62%) 
Neuropathy-sensory  2  16/89 (17.98%) 
Psychiatric disorders   
Insomnia  2  7/89 (7.87%) 
Mood alteration-depression  2  6/89 (6.74%) 
Renal and urinary disorders   
Proteinuria  2  6/89 (6.74%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  2  16/89 (17.98%) 
Cough  2  31/89 (34.83%) 
Dyspnea  2  20/89 (22.47%) 
Pharyngolaryngea  1  8/89 (8.99%) 
Skin and subcutaneous tissue disorders   
Pruritus  2  5/89 (5.62%) 
Rash desquamating  2  25/89 (28.09%) 
Rash/dermatitis  2  20/89 (22.47%) 
Vascular disorders   
Hypotension  2  6/89 (6.74%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
2
Term from vocabulary, CTCAE 2.0
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: Dr. Sonali M. Smith
Organization: University of Chicago Comprehensive Cancer Center
Phone: 7738342895
EMail: smsmith@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00290472     History of Changes
Obsolete Identifiers: NCT00084474
Other Study ID Numbers: NCI-2009-00047
NCI-2009-00047 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000365314
NCI-6199
12983A
6199 ( Other Identifier: University of Chicago )
6199 ( Other Identifier: CTEP )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
P30CA014599 ( U.S. NIH Grant/Contract )
First Submitted: February 10, 2006
First Posted: February 13, 2006
Results First Submitted: August 19, 2013
Results First Posted: February 11, 2014
Last Update Posted: May 23, 2014