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Tocilizumab for KSHV-Associated Multicentric Castleman Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01441063
Recruitment Status : Active, not recruiting
First Posted : September 27, 2011
Results First Posted : June 23, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Yarchoan, National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Castleman Disease
Multicentric Castleman Disease
Giant Lymph Node Hyperplasia
Interventions Drug: Zidovudine
Drug: Tocilizumab
Drug: Valganciclovir (VGC)
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tocilizumab
Hide Arm/Group Description

Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.

Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)

Tocilizumab: Tocilizumab 8mg/kg every 2 weeks

Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.

KSHV-MCD = Kaposi sarcoma herpes virus-associated multicentric Castleman Disease

Period Title: Tocilizumab Alone
Started 8
Completed 5
Not Completed 3
Reason Not Completed
Required AZT/VGC addition             3
Period Title: Tocilizumab + Zidovudine /Valganciclovir
Started 3
Completed 2
Not Completed 1
Reason Not Completed
Worsening KSHV-MCD symptoms             1
Arm/Group Title Tocilizumab
Hide Arm/Group Description

Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.

Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)

Tocilizumab: Tocilizumab 8mg/kg every 2 weeks

Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
47.61  (13.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
7
  87.5%
Unknown or Not Reported
1
  12.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  12.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  50.0%
White
3
  37.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Percentage of Participants With an Overall Clinical Benefit Response
Hide Description Overall clinical benefit response is defined as Complete Response (CR): Full resolution of all clinical symptoms and laboratory abnormalities (whether or not these are indicator abnormalities) probably or definitely attributable to MCD, lasting at least 3 weeks; and Partial Response (PR): At least 50% of the abnormalities probably or definitely attributed to KSHV-MCD must improve by the minimum amounts specified to attain PR. Only abnormalities present in a specific patient at baseline may count toward the achievement of a PR (e.g. if six of indicator abnormalities are present at baseline, at least three must meet the specified criteria to be considered a PR) assessed using a modified Kaposi sarcoma herpes virus-associated multicentric Castleman disease (KSHV- MCD) Clinical Benefit Response Criteria and the National Cancer Institute (NCI) KSHV-MCD criteria.
Time Frame every 2 weeks for up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Cumulative Response
63
(25 to 92)
100
(31 to 100)
Partial Response
50
(16 to 84)
67
(13 to 98)
Complete Response
13
(0 to 53)
33
(2 to 87)
2.Secondary Outcome
Title Percentage of Participants With a Clinical Response
Hide Description Clinical response is defined as a Complete Response (CR): Full resolution of all signs and symptoms attributable to MCD, lasting 1 cycle (3-4 weeks depending on regimen; Symptom Free Disease (SFD:) Full resolution of all signs and symptoms attributable to MCD, not yet lasting 1 cycle (3-4 weeks depending on regimen); and Partial Response (PR): Improvement in at least 50% of signs and symptoms by at least 1 grade (NCI-Common Terminology Criteria for Adverse Events (CTCAE v4), with no increased MCD related increases, lasting 1 cycle (3-4 weeks depending on regimen) assessed by the National Cancer Institute Kaposi sarcoma herpes virus-associated multicentric Castleman disease (NCI KSHV-MCD) Response Criteria.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Cumulative Response
75
(35 to 97)
100
(31 to 100)
Complete Response
25
(3 to 65)
33
(2 to 87)
Symptom Free Disease
0
(0 to 0)
0
(0 to 0)
Partial Response
50
(16 to 84)
67
(13 to 98)
3.Secondary Outcome
Title Percentage of Participants With a Biochemical Response
Hide Description A biochemical response is defined as a Complete Response (CR): Normalization of abnormalities attributed to MCD in the following labs: Complete blood count (CBC), Chem 20, C-Reactive protein (CRP), lasting 1 cycle (3-4 weeks depending on regimen); Partial Response (PR): 50% improvement in all labs abnormalities attributable to MCD, lasting 1 cycle (3-4 weeks depending on regimen), and was assessed by the National Cancer Institute (NCI) Kaposi sarcoma herpes virus-associated multicentric Castleman Disease (KSHV-MCD) Response Criteria.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Cumulative Response
50
(16 to 84)
100
(31 to 100)
Complete Response
13
(0 to 53)
67
(13 to 98)
Partial Response
38
(9 to 76)
33
(2 to 87)
4.Secondary Outcome
Title Percentage of Participants With a Radiographic Response
Hide Description A radiographic response is defined as a Complete Response (CR): Normalization of all lymph nodes to <1.5 cm in greatest transverse dimension, decrease to < 1 cm of lymph nodes 1.1-1.5 cm at baseline (or 75% decrease in the sum of products of diameters (SPD)), Spleen < 12 cm greatest dimension, no pleural effusions; Complete Response unconfirmed (CRu): Residual lymph node mass >1.5 cm or splenomegaly > 12 cm that has decrease by >75% and does not change over one year; and Partial Response (PR): For lymph nodes, >50% decrease in SPD of 6 dominant nodes, for spleen 50% decrease in longest transverse dimension assessed by the National Cancer Institute (NCI) Kaposi sarcoma herpes virus-associated multicentric Castleman Disease (KSHV-MCD) Response Criteria.
Time Frame up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Cumulative Response
13
(0 to 53)
0
(0 to 0)
Complete Response
0
(0 to 0)
0
(0 to 0)
Complete Response unconfirmed
0
(0 to 0)
0
(0 to 0)
Partial Response
13
(0 to 53)
0
(0 to 0)
5.Secondary Outcome
Title Percentage of Participants With Kaposi Sarcoma Responses Per the Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Response Criteria
Hide Description The ACTG Criteria is defined as a Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), and Symptom Free Disease (SFD). The terms Improved (I), Stable (S), Mixed (M) Response, and Worse (W) are also used to further describe participants who have SD or PR.
Time Frame Baseline, week 7, and at off study visit, approximately 2 weeks following last study treatment for those with KS, up to 14 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Complete Response
0
(0 to 0)
0
(0 to 0)
Partial Response
0
(0 to 0)
0
(0 to 0)
Progressive Disease
100
(16 to 100)
0
(0 to 0)
6.Secondary Outcome
Title Changes in Plasma Exposure of Ritonavir in Response to Tocilizumab and Zidovudine (AZT) Metabolized by Cytochrome P450 (CYP450)
Hide Description Cumulative plasma exposure of Ritonavir will be evaluated.
Time Frame Cycle 1 Day 1: pre Tocilizumab, and 15 minutes, 24 hrs and 48 hrs post drug; Cycle 2-6: pre Tocilizumab dose and 15 minutes post drug dose.
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because either patients were not on the antiretroviral therapies Atazanavir, Efavirenz, Ritonavir, and Lopinavir and that the timed administration of antiretrovirals (ART) and tocilizumab were not described in the protocol therefore not done.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.

Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)

Tocilizumab: Tocilizumab 8mg/kg every 2 weeks

Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Changes in Plasma Exposure of Lopinavir in Response to Tocilizumab and AZT Metabolized by Cytochrome P450 (CYP450)
Hide Description Cumulative plasma exposure of Lopinavir will be evaluated.
Time Frame Cycle 1 Day 1: pre Tocilizumab, and 15 minutes, 24 hrs and 48 hrs post drug; Cycle 2-6: pre Tocilizumab dose and 15 minutes post drug dose.
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because either patients were not on the antiretroviral therapies Atazanavir, Efavirenz, Ritonavir, and Lopinavir and that the timed administration of ART and tocilizumab were not described in the protocol therefore not done.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.

Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)

Tocilizumab: Tocilizumab 8mg/kg every 2 weeks

Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Changes in Plasma Exposure of Atazanavir in Response to Tocilizumab and Zidovudine (AZT) Metabolized by Cytochrome P450 (CYP450)
Hide Description Cumulative plasma exposure of Atazanavir will be evaluated.
Time Frame Cycle 1 Day 1: pre Tocilizumab, and 15 minutes, 24 hrs and 48 hrs post drug; Cycle 2-6: pre Tocilizumab dose and 15 minutes post drug dose.
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because either patients were not on the antiretroviral therapies Atazanavir, Efavirenz, Ritonavir, and Lopinavir and that the timed administration of ART and tocilizumab were not described in the protocol therefore not done.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.

Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)

Tocilizumab: Tocilizumab 8mg/kg every 2 weeks

Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Changes in Plasma Exposure of Efavirenz in Response to Tocilizumab and Zidovudine (AZT) Metabolized by Cytochrome P450 (CYP450)
Hide Description Cumulative plasma exposure of Efavirenz will be evaluated.
Time Frame Cycle 1 Day 1: pre Tocilizumab, and 15 minutes, 24 hrs and 48 hrs post drug; Cycle 2-6: pre Tocilizumab dose and 15 minutes post drug dose.
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because either patients were not on the antiretroviral therapies Atazanavir, Efavirenz, Ritonavir, and Lopinavir and that the timed administration of ART and tocilizumab were not described in the protocol therefore not done.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.

Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)

Tocilizumab: Tocilizumab 8mg/kg every 2 weeks

Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Percentage of Participants With Grade 3 or Greater Serious Adverse Events
Hide Description Here is the percentage of participants with Grade 3 or greater serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe or medically significant, Grade 4 is life threatening, and Grade 5 is death.
Time Frame each cycle, up to 6 years, 8 months and 24 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25
(3 to 65)
67
(12 to 98)
11.Secondary Outcome
Title Percentage of Participants With <Grade 3 Non- Serious Adverse Events
Hide Description Here is the percentage of participants with <Grade 3 non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. Grade 1 is mild and Grade 2 is moderate.
Time Frame each cycle, up to 6 years, 8 months and 24 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Cumulative <Grade 3 Adverse Events
100
(63 to 100)
100
(31 to 100)
Grade 2
100
(63 to 100)
100
(31 to 100)
Grade 1
63
(24 to 91)
100
(31 to 100)
12.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 6 years, 8 months and 24 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
3
 100.0%
13.Secondary Outcome
Title Effect of Tocilizumab on the Pharmacokinetics (PK) of Antiretroviral Agents
Hide Description Evaluate the effect of tocilizumab on the pharmacokinetics of antiretroviral agents that are cytochrome P3A4 (CYP3A4) substrates in patients with symptomatic Kaposi sarcoma herpes virus-associated multicentric Castleman Disease (KSHV-MCD).
Time Frame Cycle 1, Day 1 and Cycle 2-6 Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because either patients were not on the antiretroviral therapies Atazanavir, Efavirenz, Ritonavir, and Lopinavir and that the timed administration of ART and tocilizumab were not described in the protocol therefore not done.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg on Day 1 of a 14 day cycle a maximum of 6 cycles. If indicated, zidovudine (AZT) and valganciclovir (VGC) will be administered concurrently with tocilizumab, with day 1 of the cycle being the day tocilizumab is administered.

Zidovudine: Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)

Tocilizumab: Tocilizumab 8mg/kg every 2 weeks

Valganciclovir (VGC): Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Percentage of Participants Progression-free Survival at 4 Months
Hide Description Progression-free survival is defined as participants who progress or die by 4 months after the start of treatment with tocilizumab and tocilizumab /AZT/VGC.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25
(4 to 56)
33
(0 to 77)
15.Secondary Outcome
Title Percentage of Participants With Overall Survival 4 Months After Treatment With Tocilizumab and Tocilizumab /Zidovudine (AZT)/Valganciclovir (VGC)
Hide Description Overall survival is defined as the percentage of participants alive at 4 months after the start of treatment with tocilizumab and tocilizumab /AZT/VGC.
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description:

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
Overall Number of Participants Analyzed 8 3
Measure Type: Number
Unit of Measure: Percentage of participants
100 100
Time Frame Date treatment consent signed to date off study, approximately 6 years, 8 months and 24 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tocilizumab Monotherapy Tocilizumab Combination Therapy
Hide Arm/Group Description

All participants (e.g. 8/8) who received Tocilizumab.

Participants who fail monotherapy, may receive Tocilizumab Combination Therapy (Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).

3/8 participants who failed on Tocilizumab and received Tocilizumab + Zidovudine (AZT) and Valganciclovir (VGC).
All-Cause Mortality
Tocilizumab Monotherapy Tocilizumab Combination Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
Tocilizumab Monotherapy Tocilizumab Combination Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      0/3 (0.00%)    
General disorders     
Fever  1  1/8 (12.50%)  1 0/3 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tocilizumab Monotherapy Tocilizumab Combination Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  8/8 (100.00%)  20 1/3 (33.33%)  2
Leukocytosis  1  0/8 (0.00%)  0 2/3 (66.67%)  2
Cardiac disorders     
Sinus tachycardia  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Bloatness  1  3/8 (37.50%)  3 0/3 (0.00%)  0
Constipation  1  1/8 (12.50%)  1 2/3 (66.67%)  2
Diarrhea  1  2/8 (25.00%)  2 0/3 (0.00%)  0
Dyspepsia  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Nausea  1  2/8 (25.00%)  2 3/3 (100.00%)  4
General disorders     
Chills  1  2/8 (25.00%)  2 1/3 (33.33%)  1
Edema limbs  1  2/8 (25.00%)  2 0/3 (0.00%)  0
Fatigue  1  6/8 (75.00%)  11 0/3 (0.00%)  0
Fever  1  2/8 (25.00%)  2 1/3 (33.33%)  2
Pain  1  3/8 (37.50%)  4 1/3 (33.33%)  1
Infections and infestations     
Infections and infestations - Other, respiratory  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Infections and infestations - Other, C. Diff.  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Infections and infestations - Other, left psoas abcess  1  1/8 (12.50%)  2 0/3 (0.00%)  0
Infections and infestations - Other, specify  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Sinusitis  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  3/8 (37.50%)  4 0/3 (0.00%)  0
Alkaline phosphatase increased  1  2/8 (25.00%)  2 2/3 (66.67%)  4
Aspartate aminotransferase increased  1  2/8 (25.00%)  2 0/3 (0.00%)  0
Blood bilirubin increased  1  1/8 (12.50%)  2 1/3 (33.33%)  3
CD4 lymphocytes decreased  1  4/8 (50.00%)  5 1/3 (33.33%)  1
Cholesterol high  1  3/8 (37.50%)  3 0/3 (0.00%)  0
Creatinine increased  1  3/8 (37.50%)  4 1/3 (33.33%)  2
Haptoglobin decreased  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Lipase increased  1  4/8 (50.00%)  5 2/3 (66.67%)  2
Lymphocyte count decreased  1  5/8 (62.50%)  9 3/3 (100.00%)  7
Neutrophil count decreased  1  4/8 (50.00%)  7 3/3 (100.00%)  7
Platelet count decreased  1  3/8 (37.50%)  7 2/3 (66.67%)  5
Serum amylase increased  1  2/8 (25.00%)  4 1/3 (33.33%)  1
TSH elevated  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Weight loss  1  1/8 (12.50%)  1 0/3 (0.00%)  0
White blood cell decreased  1  3/8 (37.50%)  5 3/3 (100.00%)  5
Metabolism and nutrition disorders     
Anorexia  1  3/8 (37.50%)  5 2/3 (66.67%)  2
Hypercalcemia  1  0/8 (0.00%)  0 1/3 (33.33%)  1
Hyperglycemia  1  4/8 (50.00%)  4 2/3 (66.67%)  4
Hypertriglyceridemia  1  4/8 (50.00%)  5 0/3 (0.00%)  0
Hyperuricemia  1  1/8 (12.50%)  2 0/3 (0.00%)  0
Hypoalbuminemia  1  5/8 (62.50%)  7 2/3 (66.67%)  4
Hypomagnesemia  1  1/8 (12.50%)  1 1/3 (33.33%)  1
Hyponatremia  1  3/8 (37.50%)  3 2/3 (66.67%)  2
Hypophosphatemia  1  1/8 (12.50%)  1 1/3 (33.33%)  1
Triglyceride  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Chest wall pain  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Myalgia  1  0/8 (0.00%)  0 1/3 (33.33%)  2
Pain in extremity  1  1/8 (12.50%)  1 1/3 (33.33%)  2
Nervous system disorders     
Dizziness  1  2/8 (25.00%)  2 0/3 (0.00%)  0
Dysgeusia  1  0/8 (0.00%)  0 1/3 (33.33%)  1
Headache  1  1/8 (12.50%)  1 1/3 (33.33%)  1
Psychiatric disorders     
Insomnia  1  3/8 (37.50%)  3 0/3 (0.00%)  0
Renal and urinary disorders     
Proteinuria  1  2/8 (25.00%)  2 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/8 (12.50%)  1 1/3 (33.33%)  1
Cough  1  5/8 (62.50%)  5 0/3 (0.00%)  0
Nasal congestion  1  2/8 (25.00%)  3 1/3 (33.33%)  1
Postnasal drip  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Night Sweats  1  0/8 (0.00%)  0 1/3 (33.33%)  1
Pruritus  1  2/8 (25.00%)  3 0/3 (0.00%)  0
Rash acneiform  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1  1/8 (12.50%)  1 0/3 (0.00%)  0
Vascular disorders     
Hot flashes  1  1/8 (12.50%)  1 0/3 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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. Robert Yarchoan
Organization: National Cancer Institute
Phone: 240-760-6075
EMail: robert.yarchoan@nih.gov
Layout table for additonal information
Responsible Party: Robert Yarchoan, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01441063    
Other Study ID Numbers: 110233
11-C-0233
First Submitted: September 24, 2011
First Posted: September 27, 2011
Results First Submitted: April 14, 2020
Results First Posted: June 23, 2020
Last Update Posted: June 23, 2020