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Trial record 24 of 65 for:    HTLV

Zidovudine, Interferon Alfa-2b, PEG-Interferon Alfa-2b in Patients With HTLV-I Associated Adult T-Cell Leukemia/Lymphoma

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ClinicalTrials.gov Identifier: NCT00854581
Recruitment Status : Terminated (Investigator Decision)
First Posted : March 3, 2009
Results First Posted : January 6, 2015
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Juan C. Ramos, University of Miami

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma
Precancerous/Nonmalignant Condition
Interventions Biological: PEG-interferon alfa-2b
Biological: Interferon alfa-2b
Drug: Valproic Acid
Drug: Zidovudine
Enrollment 13

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Induction + Maintenance
Hide Arm/Group Description All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
Period Title: Induction (Up to Day 21)
Started 13
Completed 7
Not Completed 6
Reason Not Completed
Lack of Efficacy             4
Death             1
Physician Decision             1
Period Title: Part 1 Maintenance (Up to Day 60)
Started 7
Completed 5
Not Completed 2
Period Title: Part 2 Maintenance (Up to 12 Months)
Started 5
Completed 2
Not Completed 3
Reason Not Completed
Lack of Efficacy             3
Arm/Group Title Induction + Maintenance
Hide Arm/Group Description All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  92.3%
>=65 years
1
   7.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
10
  76.9%
Male
3
  23.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  84.6%
White
0
   0.0%
More than one race
2
  15.4%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Brazil
1
   7.7%
Dominican Republic
1
   7.7%
Haiti
3
  23.1%
Jamaica
5
  38.5%
St. Croix
1
   7.7%
Trinidad
2
  15.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
1.Primary Outcome
Title Number of Patients Achieving Clinical Response to Protocol Therapy Who Lack IRF-4 and/or c-Rel Expression.
Hide Description

Number of patients achieving clinical response (complete response (CR) + partial response (PR)) who lack interferon regulatory factor 4 (IRF-4) or c-Rel biomarker expression. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009.

For imaging, Cheson criteria was used to assess response:

  • Complete response (CR): Disappearance of all clinical, microscopic, and radiographic evidence of disease. All lymph nodes regressed to normal size (≤ 1.5 cm), and previously involved nodes that were 1.1 to 1.5 cm decreased to ≤ 1.0 cm. In addition, abnormally elevated peripheral blood absolute lymphocyte count (ALC) < 4 x 10^9 /L.
  • Partial response (PR): ≥ 50% reduction in measurable disease and abnormal lymphocyte count in peripheral blood.
  • CR or PR had to persist for a period of at least 4 weeks.
Time Frame Up to 12 months post-initiation of protocol therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had a treatment response (PR or CR)
Arm/Group Title Induction + Maintenance
Hide Arm/Group Description:
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Participants with tumors lacking IRF-4 Number Analyzed 6 participants
5
Participants with tumors lacking c-Rel Number Analyzed 4 participants
2
2.Primary Outcome
Title Presence of Minimal Residual Disease at 3 and 6 Months of Maintained Remission and at 1 Year Post Initiation of Therapy
Hide Description

Number of participants achieving complete response (CR) with minimal residual disease at 3, 6 and 12 months post-initiation of protocol therapy. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009.

For imaging, Cheson criteria was used to assess response:

  • Complete response (CR): Disappearance of all clinical, microscopic, and radiographic evidence of disease. All lymph nodes regressed to normal size (≤ 1.5 cm), and previously involved nodes that were 1.1 to 1.5 cm decreased to ≤ 1.0 cm. In addition, abnormally elevated peripheral blood absolute lymphocyte count (ALC) < 4 x 10^9 /L.
  • Partial response (PR): ≥ 50% reduction in measurable disease and abnormal lymphocyte count in peripheral blood.
  • CR or PR had to persist for a period of at least 4 weeks.
Time Frame 3, 6 and 12 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved CR with minimal residual disease in Part 1 Maintenance therapy at Month 3 and moved on the Part 2B maintenance for up to 12 months.
Arm/Group Title Part 2B Maintenance (Up to 12 Months)
Hide Arm/Group Description:

Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:

  • Zidovudine: 600 mg or 300 mg orally twice daily, per protocol
  • PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol
  • Valproic acid, 250 mg orally twice daily, per protocol

Valproic Acid: Administered orally.

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3 months, CR w/minimal residual disease 3
6 months, CR w/minimal residual disease 1
12 months, CR w/minimal residual disease 0
3.Primary Outcome
Title Expressions of c-Rel, IRF-4 and Other Molecular Events in Participants
Hide Description Expressions of c-Rel, IRF-4 or other molecular events (p53, p16 mutations) including expansion of novel clones obtained at time of relapse will be compared to baseline data using paired t-test.
Time Frame At time of relapse or disease progression, assessed up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study participants were tested for these markers at baseline, but only IRF4 was re-tested at relapse
Arm/Group Title Induction + Maintenance
Hide Arm/Group Description:
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants
Baseline IRF-4 Expression, Positive Number Analyzed 12 participants
3
Baseline IRF-4 Expression, Negative Number Analyzed 12 participants
9
IRF-4 Expression at Relapse, Newly Positive Number Analyzed 4 participants
2
Baseline c-Rel Expression, Faintly Positive Number Analyzed 8 participants
3
Baseline c-Rel Expression, Positive Number Analyzed 8 participants
2
Baseline c-Rel Expression, Negative Number Analyzed 8 participants
3
Baseline p53 Expression, Positive Number Analyzed 6 participants
1
Baseline p53 Expression, Negative Number Analyzed 6 participants
5
Baseline p15/16 alterations, homozygous deletion Number Analyzed 5 participants
1
Baseline p15/16 alterations, heterozygous deletion Number Analyzed 5 participants
2
Baseline p15/16 alterations, no deletions Number Analyzed 5 participants
2
4.Primary Outcome
Title Number of Participants Exhibiting NF-kB Inhibition Upon Treatment With AZT in Vivo
Hide Description Number of patients exhibiting NF-kb inhibition upon treatment with AZT in vivo. Investigation of whether AZT functions as an inhibitor of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) in vivo by analyzing serially collected leukemic samples during the first 48 hours of treatment with AZT only. The investigators will report the number of participants exhibiting NF-kB inhibition upon treatment with AZT in vivo and correlate with response using two-sample t-test.
Time Frame During 48 hours of first AZT therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants receiving Zidovudine (AZT) therapy who achieved complete response (CR) or partial response (PR).
Arm/Group Title Induction (Up to Day 21)
Hide Arm/Group Description:

For one cycle, up to Day 21. All participants are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR). Participants who achieve a clinical CR at Day 14 response assessment will go on to Part 1 maintenance therapy. Patients who achieve a PR will receive 7 more days of induction therapy and then go on to Part 1 Maintenance Therapy.:

  • Zidovudine:

    • Days 1-2: 1.5 grams intravenously (IV) twice daily
    • Days 3-21: 1.5 grams IV twice daily
  • Interferon alfa-2b (IFN):

    • 5 10 million units (mu) intravenously twice daily

Interferon alfa-2b: Administered intravenously.

Zidovudine: Administered intravenously during Induction Therapy; orally during Maintenance Therapy in all Phases (1, 2A and 2B).

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
CR with Decrease in NF-kB Complex (p50 complexes) 1
CR with no clear effect NF-kB 1
PR with Decrease in p50, and Increase in p65 1
5.Primary Outcome
Title The Effect of Valproic Acid Therapy on Persistence of Clonal Disease in Patients Who Achieve Clinical Remission
Hide Description Number of participants achieving a molecular remission after starting valproic acid as evidenced by disappearance of T-cell clonality as measured by gene rearrangement studies using multiplex PCR
Time Frame 3, 6 and 12 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants achieving CR or PR in Part 1 Maintenance and moving on to Part 2B Maintenance therapy
Arm/Group Title Part 2B Maintenance (Up to 12 Months)
Hide Arm/Group Description:

Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:

  • Zidovudine: 600 mg or 300 mg orally twice daily, per protocol
  • PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol
  • Valproic acid, 250 mg orally twice daily, per protocol

Valproic Acid: Administered orally.

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3 months, CR or PR, with molecular remission 0
6 months, CR with molecular remission 1
9 months, CR with molecular remission 1
12 months, CR with molecular remission 1
6.Secondary Outcome
Title Failure-free Survival (FFS)
Hide Description Failure-free survival is the elapsed time from the date of initiation of study treatment until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time was censored at the last documented date of failure-free status.
Time Frame From date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause, assessed up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Induction + Maintenance
Hide Arm/Group Description:
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
Overall Number of Participants Analyzed 13
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.0 to 6.9)
7.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is the elapsed time from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up was censored at date of last contact.
Time Frame From date of treatment initiation until date of death, assessed up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Induction + Maintenance
Hide Arm/Group Description:
All participants are enrolled to induction therapy first, then move to the maintenance therapy Parts 1 and 2A or 2B if they achieve complete response (PR) or partial response (PR).
Overall Number of Participants Analyzed 13
Median (95% Confidence Interval)
Unit of Measure: months
7.8
(2.5 to 46.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Induction Therapy Part 1 Maintenance Part 2A Maintenance Part 2B Maintenance
Hide Arm/Group Description

For one cycle, up to Day 21. All participants are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR). Participants who achieve a clinical CR at Day 14 response assessment will go on to Part 1 maintenance therapy. Patients who achieve a PR will receive 7 more days of induction therapy and then go on to Part 1 Maintenance Therapy.:

  • Zidovudine:

    • Days 1-2: 1.5 grams intravenously (IV) twice daily
    • Days 3-21: 1.5 grams IV twice daily
  • Interferon alfa-2b (IFN):

    • 5 10 million units (mu) intravenously twice daily

From Treatment Day 14 or 21 to start of Month 3 (Day 60). Study participants move on to Part 1 Maintenance Therapy only if they achieve complete response (CR) or partial response (PR) after induction therapy. Restaging and molecular evaluation of disease at start of Month 3:

  • Zidovudine: 600 mg orally twice daily in all phases of Maintenance Therapy
  • PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly
  • Participants then proceed to Part 2 maintenance.

Participants achieving a CR with undetectable clonal disease. Participants will receive therapy for as long as response is maintained:

  • Zidovudine: 600 mg orally twice daily
  • PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly

Participants achieving a CR with minimal residual disease (by multiplex PCR) or PR in Part 1:

  • Zidovudine: 600 mg or 300 mg orally twice daily, per protocol
  • PEG-Interferon alfa-2b: 1.5 ug/kg subcutaneously (SQ) once weekly, per protocol
  • Valproic acid, 250 mg orally twice daily, per protocol
All-Cause Mortality
Induction Therapy Part 1 Maintenance Part 2A Maintenance Part 2B Maintenance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/13 (38.46%)      2/7 (28.57%)      0/2 (0.00%)      1/3 (33.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Induction Therapy Part 1 Maintenance Part 2A Maintenance Part 2B Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      1/7 (14.29%)      1/2 (50.00%)      1/3 (33.33%)    
Blood and lymphatic system disorders         
Hemoglobin  1  0/13 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Leukocytes  1  0/13 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Neutrophils  1  0/13 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Gastrointestinal disorders         
Abdominal pain  1  0/13 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Nausea  1  0/13 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Vomiting  1  0/13 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Infections and infestations         
Infection - Other  1  2/13 (15.38%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Infection, Catheter-related  1  1/13 (7.69%)  1 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Sepsis  1  1/13 (7.69%)  1 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Urinary tract infection  1  0/13 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Metabolism and nutrition disorders         
Hypercalcemia  1  0/13 (0.00%)  0 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders         
Renal failure  1  0/13 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea  1  0/13 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Induction Therapy Part 1 Maintenance Part 2A Maintenance Part 2B Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/13 (92.31%)      2/7 (28.57%)      1/2 (50.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders         
Edema limbs  1  3/13 (23.08%)  3 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Edema: Head and Neck  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Febrile Neutropenia  1  1/13 (7.69%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hemoglobin  1  3/13 (23.08%)  7 1/7 (14.29%)  1 1/2 (50.00%)  1 1/3 (33.33%)  1
Leukocytes  1  2/13 (15.38%)  4 0/7 (0.00%)  0 1/2 (50.00%)  1 1/3 (33.33%)  1
Lymphatics - Other  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Neutrophils  1  4/13 (30.77%)  6 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Cardiac disorders         
Sinus tachycardia  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Endocrine disorders         
Scleral necrosis  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders         
Abdominal Distension  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Abdominal Pain  1  0/13 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Anorexia  1  2/13 (15.38%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Dyspepsia  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Heartburn  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Mucositis oral  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Nausea  1  1/13 (7.69%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Vomiting  1  1/13 (7.69%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
General disorders         
Chills  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Fatigue  1  0/13 (0.00%)  0 2/7 (28.57%)  2 0/2 (0.00%)  0 2/3 (66.67%)  3
Fever  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Rigors/chills  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations         
Abdominal Infection  1  0/13 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Infection - Other  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Infection, Bladder (urinary)  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Infection, normal ANC, Catheter-related  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Infection, Urinary tract NOS  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Sepsis  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Sinusitis  1  0/13 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Urinary tract infection  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Investigations         
Neutrophil count decreased  1  5/13 (38.46%)  7 0/7 (0.00%)  0 1/2 (50.00%)  2 2/3 (66.67%)  2
Platelet count decreased  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders         
Alanine aminotransferase increased  1  0/13 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
Alkaline phosphatase increased  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Aspartate aminotransferase increased  1  2/13 (15.38%)  4 1/7 (14.29%)  1 1/2 (50.00%)  1 0/3 (0.00%)  0
Hypercalcemia  1  2/13 (15.38%)  3 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hypokalemia  1  3/13 (23.08%)  4 2/7 (28.57%)  2 0/2 (0.00%)  0 0/3 (0.00%)  0
Hypomagnesemia  1  6/13 (46.15%)  8 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hyponatremia  1  2/13 (15.38%)  3 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Hypophosphatemia  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders         
Peripheral sensory neuropathy  1  2/13 (15.38%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Psychiatric disorders         
Depression  1  1/13 (7.69%)  1 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnea  1  1/13 (7.69%)  2 1/7 (14.29%)  1 0/2 (0.00%)  0 0/3 (0.00%)  0
Nasal congestion  1  0/13 (0.00%)  0 0/7 (0.00%)  0 0/2 (0.00%)  0 1/3 (33.33%)  1
Pulmonary - Other  1  1/13 (7.69%)  2 0/7 (0.00%)  0 0/2 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus  1  0/13 (0.00%)  0 0/7 (0.00%)  0 1/2 (50.00%)  1 0/3 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Juan Carlos Ramos MD
Organization: University of Miami
Phone: 305-243-4909
Responsible Party: Juan C. Ramos, University of Miami
ClinicalTrials.gov Identifier: NCT00854581     History of Changes
Other Study ID Numbers: 20070805
SCCC-2007055 ( Other Identifier: UM/Sylvester Comprehensive Cancer Center )
5P01CA128115-02 ( U.S. NIH Grant/Contract )
First Submitted: February 28, 2009
First Posted: March 3, 2009
Results First Submitted: December 22, 2014
Results First Posted: January 6, 2015
Last Update Posted: April 17, 2018