Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00072280
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 7
• Locations: 74
• Arms: 2
• Duration (Months): 40
• Patients Per Site: 0.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving combination chemotherapy after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well surgery and/or combination chemotherapy work in treating children with fibrosarcoma.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Biological: dactinomycin; Drug: cyclophosphamide; Drug: etoposide; Drug: ifosfamide; Drug: vincristine sulfate; Procedure: Conventional Surgery; Biological: MESNA (mercaptoethane sulfonate); Biological: Filgrastim	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the event-free and relapse-free survival of children with initially unresectable congenital, infantile, or childhood fibrosarcoma treated with neoadjuvant chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC) before definitive local control.

Secondary

• Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by observation after local control with positive microscopic margins.

• Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by additional chemotherapy comprising etoposide and ifosfamide after local control with gross positive margins.

• Determine the event-free and relapse-free survival of patients treated with surgery alone.

OUTLINE: This is a pilot, multicenter study. Patients begin treatment according to lesion resectability.

Patients with resectable lesions proceed to surgery.

• Surgery: Patients undergo resection of disease lesions. Patients with clear or microscopically positive margins undergo observation only. Patients with grossly positive margins undergo re-resection if feasible. Patients with grossly positive margins after re-resection or for whom re-resection is not feasible receive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC).

Patients with unresectable lesions receive VAC chemotherapy.

• VAC chemotherapy: Patients receive vincristine intravenously (IV) on days 1, 8, and 15 and dactinomycin IV and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with disease progression after 2-4 courses of VAC chemotherapy proceed to chemotherapy comprising etoposide and ifosfamide (IE).

Patients with stable disease after 4 courses of VAC chemotherapy proceed to IE chemotherapy.

Patients with a partial response (PR) and unresectable lesions after 4 courses of VAC chemotherapy receive 2 additional courses of VAC and are then re-evaluated. Patients proceed to surgery if they continue to have a PR or achieve a complete response (CR) and lesions are now resectable.

Patients with a CR or PR and resectable lesions after 4 courses of VAC chemotherapy proceed to surgery.

Patients with stable disease, progressive disease, or a PR and unresectable lesions after 6 courses of VAC proceed to IE chemotherapy.

• IE chemotherapy: Patients receive etoposide IV over 1 hour and ifosfamide IV over 1 hour on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients with a CR or PR and resectable lesions after 2-4 courses of IE chemotherapy proceed to surgery.

All patients are followed every 3 months for 6 months, every 6 months for 1 year, and then as clinically indicated.

PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study within 8 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Phase II Study for Children With Infantile Fibrosarcoma
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemotherapy plus possible surgery Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.)	Biological: dactinomycin; Given Slow intravenous (IV) push over 1-5 minutes, dose < 1yr 0.025 mg/kg > or = 1 yr 0.045 mg/kg (max dose 2.5 mg) on days 1,22,43 and 64; Other Names: DACT Actinomycin-D Cosmegen NSC #3053 ; Drug: cyclophosphamide; Given IV over 60 minutes, dose 25 mg/kg on days 1,22,43 and 64.; Other Names: Cytoxan NSC #26271 ; Drug: etoposide; Given IV over 1 hour, dose 3.3 mg/kg in normal saline (NS) 10 cc/kg (or to equal 0.4 mg/mL concentration) on days 1-5 of IE cycle.; Other Names: ETOP VePesid Etopophos VP-16 NSC #141540 ; Drug: ifosfamide; Given IV over 1 hour, dose 60mg/kg in D5 1/4 NS 10 cc/kg IV on days 1-5 of IE Cycle; Other Names: Isophosphamide Iphosphamide Z4942 Ifex NSC #109724 ; Drug: vincristine sulfate; Given IV Push over 1 minute, dose 0.05 mg/kg (max dose 2 mg) on days 1,8,15,22,29,36,43,50,57 and 64; Other Names: Oncovin VCR LCR NSC #67574 ; Procedure: Conventional Surgery; Applied only when lesion is resectable. Surgery is the primary means of local control in this study and reasonable attempts at achieving clear margins with an "envelope" of normal tissue should be undertaken at the initial and/or subsequent resections.; Biological: MESNA (mercaptoethane sulfonate); Given orally. Oral daily MESNA dose is equal to at least 60% of the daily cyclophosphamide dose.; Other Names: Sodium 2-mercaptoethane sulfonate UCB 3983 Mesnex NSC #113891 ; Biological: Filgrastim; Given IV - Only use filgrastim if chemotherapy has been delayed or modified for hematologic toxicity, or if patient experiences a significant life-threatening toxicity due to bone marrow suppression; Other Names: Granulocyte Colony-Stimulating Factor r-metHuG-CSF G-CSF Neupogen NSC #614629
Experimental: Surgery only Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.	Procedure: Conventional Surgery; Applied only when lesion is resectable. Surgery is the primary means of local control in this study and reasonable attempts at achieving clear margins with an "envelope" of normal tissue should be undertaken at the initial and/or subsequent resections.

Outcome Measures

Primary Outcome Measures

1. Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm [Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)]

   Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed infantile, congenital, or pediatric fibrosarcoma

• Initial biopsy or surgery performed within the past 35 days

• No evidence of distant metastases

• Available tissue for central review

PATIENT CHARACTERISTICS:

Age

• Under 2 at diagnosis

Performance status

• Zubrod Score (ECOG)

Life expectancy

• At least 8 weeks

Hematopoietic

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3*

• Hemoglobin at least 10.0 g/dL* NOTE: *Transfusions allowed

Hepatic

• Total bilirubin no greater than 1.5 times upper limit of normal (ULN) (patients over 4 weeks of age)

• Patients under 4 weeks of age with an indirect hyperbilirubinemia are eligible, provided the following criteria are met:

• At least 2 bilirubin values at separate timepoints show a decrease in measurement

• Direct bilirubin is no greater than 20% of the total bilirubin

• Direct bilirubin no greater than 1.5 times ULN

• Alanine Aminotransferase (ALT) less than 2.5 times ULN

Renal

• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

PRIOR/CONCURRENT THERAPY:

Biologic therapy

• No concurrent sargramostim (GM-CSF)

Chemotherapy

• No prior chemotherapy

• No other concurrent anticancer chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior or concurrent radiotherapy except emergent radiotherapy for impending tracheal compression

Surgery

• See Disease Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Children's Hospital	Phoenix	Arizona	United States	85016-7710
2	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
3	Southern California Permanente Medical Group	Downey	California	United States	90242-2814
4	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California	United States	92354
5	Jonathan Jaques Children's Cancer Center at Miller Children's Hospital	Long Beach	California	United States	90801
6	Kaiser Permanente Medical Center - Oakland	Sacramento	California	United States	95825
7	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94115
8	Stanford Comprehensive Cancer Center - Stanford	Stanford	California	United States	94305
9	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center	Farmington	Connecticut	United States	06360-2875
10	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
11	Lee Cancer Care of Lee Memorial Health System	Fort Myers	Florida	United States	33901
12	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136
13	Sacred Heart Cancer Center at Sacred Heart Hospital	Pensacola	Florida	United States	32504
14	All Children's Hospital	St. Petersburg	Florida	United States	33701
15	St. Joseph's Cancer Institute at St. Joseph's Hospital	Tampa	Florida	United States	33607
16	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
17	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912-3730
18	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
19	St. Vincent Indianapolis Hospital	Indianapolis	Indiana	United States	46260
20	Kosair Children's Hospital	Louisville	Kentucky	United States	40232
21	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
22	CancerCare of Maine at Eastern Maine Medial Center	Bangor	Maine	United States	04401
23	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
24	Hurley Medical Center	Flint	Michigan	United States	48503
25	Spectrum Health Hospital - Butterworth Campus	Grand Rapids	Michigan	United States	49503-2560
26	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
27	Children's Hospitals and Clinics of Minneapolis	Minneapolis	Minnesota	United States	55404
28	University of Minnesota Medical Center & Children's Hospital - Fairview	Minneapolis	Minnesota	United States	55455
29	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
30	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
31	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey	United States	07601
32	Overlook Hospital	Morristown	New Jersey	United States	07962
33	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York	United States	10032
34	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
35	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
36	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
37	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
38	Children's Hospital Medical Center of Akron	Akron	Ohio	United States	44308-1062
39	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
40	Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106-5000
41	Columbus Children's Hospital	Columbus	Ohio	United States	43205-2696
42	Children's Medical Center - Dayton	Dayton	Ohio	United States	45404-1815
43	Tod Children's Hospital - Forum Health	Youngstown	Ohio	United States	44501
44	OU Cancer Institute	Oklahoma City	Oklahoma	United States	73104
45	Geisinger Medical Center	Danville	Pennsylvania	United States	17822-0001
46	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
47	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-9786
48	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island	United States	02903
49	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425
50	Greenville Hospital System Cancer Center	Greenville	South Carolina	United States	29605
51	East Tennessee Children's Hospital	Knoxville	Tennessee	United States	37916
52	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105
53	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6310
54	Medical City Dallas Hospital	Dallas	Texas	United States	75230
55	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390
56	Baylor University Medical Center - Houston	Houston	Texas	United States	77030-2399
57	Covenant Children's Hospital	Lubbock	Texas	United States	79410
58	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78207
59	Methodist Children's Hospital of South Texas	San Antonio	Texas	United States	78229-3993
60	Primary Children's Medical Center	Salt Lake City	Utah	United States	84113-1100
61	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington	United States	99220-2555
62	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
63	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
64	Midwest Children's Cancer Center	Milwaukee	Wisconsin	United States	53226
65	Westmead Institute for Cancer Research at Westmead Hospital	Westmead	New South Wales	Australia	2145
66	Women's and Children's Hospital	North Adelaide	South Australia	Australia	5006
67	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 1Z2
68	Children's & Women's Hospital of British Columbia	Vancouver	British Columbia	Canada	V6H 3V4
69	IWK Health Centre	Halifax	Nova Scotia	Canada	B3K 6R8
70	Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8
71	Montreal Children's Hospital at McGill University Health Center	Montreal	Quebec	Canada	H3H 1P3
72	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
73	Saskatoon Cancer Centre at the University of Saskatchewan	Saskatoon	Saskatchewan	Canada	S7N 4H4
74	Starship Children's Health	Auckland		New Zealand	1

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Mignon Loh, MD, University of California, San Francisco
• Study Chair: Anne B. Warwick, MD, MPH, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT00072280
• Other Study ID Numbers: ARST03P1; CDR0000339565; NCI-2012-02561; COG-ARST03P1
• First Posted: Nov 6, 2003
• Last Update Posted: Sep 30, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Children's Oncology Group: childhood fibrosarcoma; nonmetastatic childhood soft tissue sarcoma
• Additional relevant MeSH terms: Sarcoma; Fibrosarcoma; Dactinomycin; Cyclophosphamide; Ifosfamide; Isophosphamide mustard; Etoposide; Vincristine; Lenograstim; Mesna

Study Results

Participant Flow

Arm/Group Title	Chemotherapy Plus Possible Surgery	Surgery Only
Arm/Group Description	Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.)	Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
Period Title: Treatment
STARTED	3	4
COMPLETED	2	2
NOT COMPLETED	1	2
Period Title: Treatment
STARTED	2	2
COMPLETED	0	0
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Chemotherapy Plus Possible Surgery	Surgery Only	Total
Arm/Group Description	Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.)	Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.	Total of all reporting groups
Overall Participants	3	4	7
Age (Count of Participants)
<=18 years	3 100%	4 100%	7 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age, Customized (participants) [Number]
Less than 6 months	2 66.7%	2 50%	4 57.1%
6 months or more	1 33.3%	2 50%	3 42.9%
Sex: Female, Male (Count of Participants)
Female	2 66.7%	2 50%	4 57.1%
Male	1 33.3%	2 50%	3 42.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 25%	1 14.3%
Not Hispanic or Latino	3 100%	3 75%	6 85.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 66.7%	0 0%	2 28.6%
White	1 33.3%	4 100%	5 71.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	1 33.3%	4 100%	5 71.4%
Canada	1 33.3%	0 0%	1 14.3%
Australia	1 33.3%	0 0%	1 14.3%

Outcome Measures

1. Primary Outcome

Title	Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm
Description	Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).
Time Frame	Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)

Outcome Measure Data

Analysis Population Description

By protocol design, only eligible patients were considered in the evaluation for the primary outcome measure. One (1) patient was found ineligible, leaving two (2) for the analysis population.

Arm/Group Title	Chemotherapy Plus Possible Surgery
Arm/Group Description	Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.)
Measure Participants	2
Failed	1 33.3%
Failure-free through 5 years of follow-up	0 0%
Failure-free at cutoff (if < 5 years follow-up)	1 33.3%
Withdrew from study	0 0%
Lost to follow-up	0 0%

Adverse Events

Adverse Event Reporting Description	All eligible patients were considered in the evaluation of adverse events (AEs). Three (3) patients were considered ineligible. All other patients (two on each study arm) are included in AE reporting.
Arm/Group Title	Chemotherapy Plus Possible Surgery		Surgery Only
Arm/Group Description	Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.)		Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
All Cause Mortality
	Chemotherapy Plus Possible Surgery		Surgery Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Chemotherapy Plus Possible Surgery		Surgery Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Chemotherapy Plus Possible Surgery		Surgery Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		0/2 (0%)
Blood and lymphatic system disorders
Anemia	1/2 (50%)		0/2 (0%)
Infections and infestations
Infections and infestations - Other, specify	1/2 (50%)		0/2 (0%)
Investigations
Neutrophil count decreased	1/2 (50%)		0/2 (0%)

Limitations/Caveats

Study closed early due to slow accrual. Analysis plans were not carried out (lack of statistical precision compromised the ability to draw appropriate conclusions). Reported Primary Outcome Measure data reflects data collection through March 2008.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Must obtain prior Sponsor approval.