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Trial record 4 of 4 for:    7800006 [PUBMED-IDS]

A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas

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ClinicalTrials.gov Identifier: NCT00001566
Recruitment Status : Completed
First Posted : November 4, 1999
Results First Posted : June 12, 2012
Last Update Posted : June 15, 2012
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ewing's Sarcoma
Rhabdomyosarcoma
Interventions Biological: therapeutic autologous dendritic cells
Drug: indinavir sulfate
Procedure: peripheral blood stem cell transplantation
Enrollment 42
Recruitment Details 42 patients were enrolled in this study.
Pre-assignment Details  
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Period Title: Overall Study
Started 42
Completed Immunotherapy 23
Completed 23
Not Completed 19
Reason Not Completed
patients' choice to discontinue protocol             3
stopped after C3 due to symptomatic PD             1
Death             13
Lost to Follow-up             1
unable to complete initial apheresis             1
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
<=18 years
26
  61.9%
Between 18 and 65 years
16
  38.1%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants
18.67  (8.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
17
  40.5%
Male
25
  59.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Hispanic or Latino
2
   4.8%
Not Hispanic or Latino
40
  95.2%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
1.Primary Outcome
Title Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution
Hide Description Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0. Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. Non-tumor specific peptide:HPV16E7 MLDLQPETT-MET-9-THR. See protocol link module for additional information re: peptides.
Time Frame 20 weeks post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description:
Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Participants
Immune response to tumor specific peptides 9
Immune response to non-tumor specific peptides 23
2.Primary Outcome
Title The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy
Hide Description CD4 counts were measured from peripheral blood using standard flow cytometric techniques at the following timepoints: 2 months post-chemotherapy, 4 months post-chemotherapy and 6 months post-chemotherapy. To be eligible for evaluation for this endpoint, patient much have been <10 years of age and sustained a CD4 count of <300 cells/mcl upon completion of standard therapy. Recovery was defined as a CD4 count > 500 cells/mcl at any timepoint within 6 months of completing chemotherapy.
Time Frame 2 to 6 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description:
Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Percentage of participants
12.5
3.Primary Outcome
Title Number of Participants With an Immune Response to the Translocation Breakpoint Peptide
Hide Description Immune responses were measured following 3 sequential influenza vaccines during the same period as the peptide-pulsed dendritic cell vaccines.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description:
Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Participants
9
4.Primary Outcome
Title Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7
Hide Description Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
12 patients were human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+) and therefore evaluable for response to E7 peptides.
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description:
Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Participants
3
5.Primary Outcome
Title Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation
Hide Description Immune response was defined as a percent specific lysis of >10% following challenge with tumor peptide pulsed targets, or interferon gamma production following challenge with tumor peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0 to tumor peptide targets.Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. See protocol link module for additional information re: peptides.
Time Frame Once per enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description:
Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Participants
5
6.Secondary Outcome
Title Percentage of Participants Overall Survival
Hide Description Overall survival is defined as the time between the first day of treatment to the day of death.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description:
Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: Percentage of participants
43
7.Secondary Outcome
Title Percent of Participants: Event Free Survival
Hide Description Event free survival is calculated from the date of diagnosis for patients enrolled with newly diagnosed metastatic disease and from the date of the last recurrence detection before enrollment on this study for patients with recurrent disease.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description:
Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: Percentage of participants
31
8.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description:
Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: Participants
27
9.Secondary Outcome
Title Median Overall Survival
Hide Description Overall survival is defined as the time between the first day of treatment to the day of death.
Time Frame 5.4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description:
Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
Overall Number of Participants Analyzed 42
Median (Full Range)
Unit of Measure: Years
4.1
(3.4 to 5.4)
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Hide Arm/Group Description Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
All-Cause Mortality
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Affected / at Risk (%) # Events
Total   15/42 (35.71%)    
Blood and lymphatic system disorders   
Hemorrhage   1/42 (2.38%)  1
Thrombocytopenia   2/42 (4.76%)  2
Gastrointestinal disorders   
Abdominal pain or cramping   1/42 (2.38%)  1
Anorexia   1/42 (2.38%)  1
Diarrhea   2/42 (4.76%)  2
Investigations   
CPK (Creatine phosphokinase)   1/42 (2.38%)  1
Elevated total bilirubin   1/42 (2.38%)  1
Leukocytes   1/42 (2.38%)  2
Neutropenia   3/42 (7.14%)  4
Neutrophils   1/42 (2.38%)  2
Nervous system disorders   
Headache   1/42 (2.38%)  1
Skin and subcutaneous tissue disorders   
Rash   1/42 (2.38%)  2
Rash with macules/papules   1/42 (2.38%)  1
Skin rash   1/42 (2.38%)  1
Vascular disorders   
DVT (deep vein thrombosis)   1/42 (2.38%)  1
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%
Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy
Affected / at Risk (%) # Events
Total   27/42 (64.29%)    
Blood and lymphatic system disorders   
Anemia   6/42 (14.29%)  9
Hemoglobin   1/42 (2.38%)  1
Petechiae   1/42 (2.38%)  1
Thrombocytopenia   7/42 (16.67%)  9
Cardiac disorders   
Tachycardia   1/42 (2.38%)  1
Ear and labyrinth disorders   
Ear pain/infection   1/42 (2.38%)  1
Ears ringing   1/42 (2.38%)  4
Ears ringing and clogged   1/42 (2.38%)  1
Left ear ringing   1/42 (2.38%)  1
Loss of balance   1/42 (2.38%)  1
Otitis media   1/42 (2.38%)  1
Endocrine disorders   
Hyperthyroid   1/42 (2.38%)  1
Hypothyroid   2/42 (4.76%)  2
Eye disorders   
Double vision   1/42 (2.38%)  1
Eye pain   1/42 (2.38%)  1
Eye swollen   1/42 (2.38%)  1
Eyes watery   1/42 (2.38%)  1
Hemorrhage sclera   1/42 (2.38%)  1
Injection sclera   1/42 (2.38%)  1
Ptosis   1/42 (2.38%)  1
Stye (L) lower corner eye   2/42 (4.76%)  2
Gastrointestinal disorders   
Abdominal discomfort   1/42 (2.38%)  1
Abdominal pain   2/42 (4.76%)  5
Acid reflux   1/42 (2.38%)  6
Bad taste in mouth   1/42 (2.38%)  1
Bitter taste in mouth   1/42 (2.38%)  4
Chelitis   1/42 (2.38%)  1
Constipation   2/42 (4.76%)  3
Decreased appetite   3/42 (7.14%)  4
Diarrhea   8/42 (19.05%)  10
Dry heaves   1/42 (2.38%)  1
Dry lips   2/42 (4.76%)  2
Emesis   2/42 (4.76%)  7
Flatulence   1/42 (2.38%)  1
Gas build-up   1/42 (2.38%)  1
Gas pains   1/42 (2.38%)  1
Gum line bump (L. upper)   1/42 (2.38%)  1
Heartburn   2/42 (4.76%)  7
Indigestion   1/42 (2.38%)  1
Loose stool   2/42 (4.76%)  8
Loose stools   1/42 (2.38%)  1
Minor sore throat   1/42 (2.38%)  1
Nausea   12/42 (28.57%)  24
Nausea/vomiting   2/42 (4.76%)  2
Sore mouth   1/42 (2.38%)  2
Stomach ache   3/42 (7.14%)  4
Stomach burning   1/42 (2.38%)  3
Stomach pain   3/42 (7.14%)  3
Upset stomach   3/42 (7.14%)  3
Vomiting   10/42 (23.81%)  15
General disorders   
Achy   1/42 (2.38%)  1
Chest tightness   1/42 (2.38%)  1
Chills   7/42 (16.67%)  14
Cold   2/42 (4.76%)  2
Cranky   1/42 (2.38%)  1
Decreased flexibility swelling left leg   1/42 (2.38%)  1
Edema   1/42 (2.38%)  1
Edema media R mid-thigh   1/42 (2.38%)  1
Edema on foot   1/42 (2.38%)  2
Edema, facial   2/42 (4.76%)  2
Fatigue   16/42 (38.10%)  24
Fever   12/42 (28.57%)  25
Fever (by touch)   1/42 (2.38%)  1
Fever (by touch-low grade)   1/42 (2.38%)  1
Fever blister   1/42 (2.38%)  3
Fever-low grade (by touch)   1/42 (2.38%)  1
flu symptoms   3/42 (7.14%)  8
Flu-like symptoms   4/42 (9.52%)  4
Flush cheeks   1/42 (2.38%)  1
Flush, facial   2/42 (4.76%)  2
Flushed   1/42 (2.38%)  1
Flushed skin   1/42 (2.38%)  1
Flushing   2/42 (4.76%)  3
Foot drop   1/42 (2.38%)  1
Generalized pain   1/42 (2.38%)  1
Glands swoll   1/42 (2.38%)  1
Increase fatigue   1/42 (2.38%)  1
Injection reaction   7/42 (16.67%)  38
Intermittent fatigue   1/42 (2.38%)  4
Irritable   1/42 (2.38%)  1
Jaw pain   1/42 (2.38%)  1
L anterior chest pain   1/42 (2.38%)  1
Left chest pressure   1/42 (2.38%)  1
Malaise   5/42 (11.90%)  6
Malleolus (pain)   1/42 (2.38%)  1
Pain   1/42 (2.38%)  1
Pain injection site   1/42 (2.38%)  1
Pain R foot   1/42 (2.38%)  1
Pain R hip   1/42 (2.38%)  1
Pain tailbone   1/42 (2.38%)  2
Perior edema   1/42 (2.38%)  2
Pretib edema   1/42 (2.38%)  1
Puffy face   1/42 (2.38%)  1
Shoulder pain   1/42 (2.38%)  2
Swell ankle   1/42 (2.38%)  1
Swell tongue   1/42 (2.38%)  1
Swelling lip   1/42 (2.38%)  1
Swelling-lower extremity   1/42 (2.38%)  1
Tiredness   1/42 (2.38%)  1
Weakness   1/42 (2.38%)  1
Decreased L leg flexibility   2/42 (4.76%)  2
Pain, legs   1/42 (2.38%)  1
Hepatobiliary disorders   
Elevated D bili   4/42 (9.52%)  4
Elevated LFT's (liver function tests)   1/42 (2.38%)  1
Hyperbilirubin   1/42 (2.38%)  1
Infections and infestations   
Inf IV site   1/42 (2.38%)  1
Injury, poisoning and procedural complications   
Bruise   1/42 (2.38%)  1
Scrape on face   1/42 (2.38%)  1
Scratch under left eye   1/42 (2.38%)  1
Investigations   
Elevated creat   1/42 (2.38%)  1
Elevated creatin   1/42 (2.38%)  1
Elevated SGOT(serum glutamic oxaloacetic transaminase)   8/42 (19.05%)  8
Elevated SGPT (serum glutamic pyruvic transaminase)   10/42 (23.81%)  14
Elevated BUN   1/42 (2.38%)  1
Elevated creatinine   1/42 (2.38%)  1
Eosinophilia   13/42 (30.95%)  33
INC SGOT (serum glutamic oxaloacetic transaminase)   1/42 (2.38%)  2
INC SGPT (serum glutamic pyruvic transaminase)   1/42 (2.38%)  5
Leukocytes   1/42 (2.38%)  7
Low CO2   1/42 (2.38%)  1
Neutropenia   5/42 (11.90%)  6
Neutrophils   1/42 (2.38%)  5
Platelets   1/42 (2.38%)  2
Weight gain   6/42 (14.29%)  6
Weight loss   3/42 (7.14%)  3
Elevated total bilirubin   3/42 (7.14%)  3
Metabolism and nutrition disorders   
Alkaline phosphate elevated   7/42 (16.67%)  10
ALT (SGPT)   1/42 (2.38%)  5
AST (SGOT)   2/42 (4.76%)  3
Decreased uric acid   1/42 (2.38%)  1
Elevated glucose   2/42 (4.76%)  2
Elevated magnesium   2/42 (4.76%)  3
Glucosuria   1/42 (2.38%)  1
Hyperglycemia   3/42 (7.14%)  3
Hypoglycemia   1/42 (2.38%)  1
Hypomagnesemia   1/42 (2.38%)  1
Hyponatremia   1/42 (2.38%)  2
Low albumin   3/42 (7.14%)  3
Low potassium   1/42 (2.38%)  1
Elevated uric acid   1/42 (2.38%)  1
Elev phos   1/42 (2.38%)  1
Musculoskeletal and connective tissue disorders   
Achiness   1/42 (2.38%)  1
Back pain   3/42 (7.14%)  7
Bilateral flank pain   1/42 (2.38%)  1
Drainage on foot   1/42 (2.38%)  2
Intermittent pain in shaft of R tibia   3/42 (7.14%)  3
Intermittent cramping legs   1/42 (2.38%)  1
Joint pain   2/42 (4.76%)  2
Leg pain   2/42 (4.76%)  2
Lower back soreness   2/42 (4.76%)  3
Muscle aches   1/42 (2.38%)  1
Muscle atrophy   1/42 (2.38%)  3
Myalgia   3/42 (7.14%)  3
Myalgia-bilateral thighs   1/42 (2.38%)  1
Quad muscle soreness   1/42 (2.38%)  4
Quad/muscle pain   1/42 (2.38%)  1
Soreness under ribs   1/42 (2.38%)  1
Soreness/achiness   1/42 (2.38%)  1
Stiff neck   1/42 (2.38%)  1
Weakness (L. leg)   1/42 (2.38%)  2
Nervous system disorders   
Dizziness   2/42 (4.76%)  2
Dizzy   1/42 (2.38%)  1
Headache   11/42 (26.19%)  14
Intermittent H/A (headache)   3/42 (7.14%)  6
Lethargic   1/42 (2.38%)  1
Lips numb   2/42 (4.76%)  2
Numbness in feet and hands   2/42 (4.76%)  3
Occipital (mild pain)   1/42 (2.38%)  1
Prickling sensation   1/42 (2.38%)  1
Psychiatric disorders   
Anxiety   2/42 (4.76%)  2
Anxiety symptoms   1/42 (2.38%)  1
Insomnia   3/42 (7.14%)  4
Intermittent insomnia   1/42 (2.38%)  3
Restlessness   1/42 (2.38%)  1
Renal and urinary disorders   
Decreased urine output (o/p)   1/42 (2.38%)  1
Hematuria   7/42 (16.67%)  10
Kidney stone   1/42 (2.38%)  1
Proteinuria   8/42 (19.05%)  17
Respiratory, thoracic and mediastinal disorders   
Congestion   3/42 (7.14%)  4
Cough   5/42 (11.90%)  9
Cough (dry)   1/42 (2.38%)  2
Cough (mild, intermittent)   1/42 (2.38%)  3
Cough nonproductive   1/42 (2.38%)  1
Dry cough   1/42 (2.38%)  1
Nasal congestion   11/42 (26.19%)  18
Nasal drainage   1/42 (2.38%)  1
Nose bleed   1/42 (2.38%)  1
Nose congestion   1/42 (2.38%)  1
Pressure in chest with inhalation   1/42 (2.38%)  3
Rhinitis   1/42 (2.38%)  2
Rhinorrhea   1/42 (2.38%)  1
Runny nose   1/42 (2.38%)  1
Sore throat   3/42 (7.14%)  4
Stuffy nose   2/42 (4.76%)  2
Throat pain   1/42 (2.38%)  1
URI (upper respiratory infection)   3/42 (7.14%)  4
Skin and subcutaneous tissue disorders   
Acne (rash) on chest   1/42 (2.38%)  4
Discoloration skin (L) hand   2/42 (4.76%)  2
Dry scaly peeling skin   1/42 (2.38%)  1
Dry scaly skin   1/42 (2.38%)  1
Dry skin   4/42 (9.52%)  5
Erythema   2/42 (4.76%)  3
Hives   1/42 (2.38%)  1
Impetigo   1/42 (2.38%)  1
Induration   1/42 (2.38%)  2
Induration injection site   1/42 (2.38%)  5
Itching   1/42 (2.38%)  1
Itching (chest)   1/42 (2.38%)  1
Itching/injection site   1/42 (2.38%)  3
Itchy L. leg   1/42 (2.38%)  1
Itchy scratch under left eye   1/42 (2.38%)  1
Night sweat   1/42 (2.38%)  1
Patchy dry skin/itch trunk   1/42 (2.38%)  2
Pruritis   3/42 (7.14%)  3
Rash   4/42 (9.52%)  5
Rash, chest   1/42 (2.38%)  1
Rash, arm/chs   1/42 (2.38%)  1
Rash/redness (top of arm)   1/42 (2.38%)  1
Skin peeling   1/42 (2.38%)  1
Skin sensation   1/42 (2.38%)  1
Sweating   1/42 (2.38%)  1
Ulceration (R) heel   1/42 (2.38%)  4
Ulceration L heel   1/42 (2.38%)  1
Itchy legs   1/42 (2.38%)  4
Vascular disorders   
Hot feeling   1/42 (2.38%)  1
Hypertension   1/42 (2.38%)  2
Hypotension   4/42 (9.52%)  4
Vascular   1/42 (2.38%)  1
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
Name/Title: Crystal Mackall, M.D.
Organization: National Cancer Institute (NCI), National Institutes of Health (NIH)
Phone: 301-402-5940
Responsible Party: Crystal L. Mackall, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00001566     History of Changes
Obsolete Identifiers: NCT00019266
Other Study ID Numbers: 970052
97-C-0052
First Submitted: November 3, 1999
First Posted: November 4, 1999
Results First Submitted: March 28, 2012
Results First Posted: June 12, 2012
Last Update Posted: June 15, 2012