Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT00066248

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arms

Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer.

PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor Central Nervous System Tumors Cachexia Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Unspecified Childhood Solid Tumor, Protocol Specific	Drug: cyproheptadine hydrochloride Drug: megestrol acetate	Phase 2

Detailed Description

OBJECTIVES:

Determine the efficacy of cyproheptadine in preventing further weight loss in children with cancer or cancer treatment-related cachexia.
Determine the efficacy of megestrol in preventing further weight loss in patients who don't respond to cyproheptadine.
Determine how these drugs affect body protein and fat levels in these patients.

OUTLINE: Patients receive oral cyproheptadine twice daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients that present with weight loss after 4 weeks receive oral megestrol daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients responding to either cyproheptadine or megestrol may continue treatment at the discretion of the treating physician.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Subjects that respond to Periactin Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.	Drug: cyproheptadine hydrochloride Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks. Other Names: Periactin
Experimental: Non-responders to Periactin- Megace Arm Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.	Drug: cyproheptadine hydrochloride Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks. Other Names: Periactin Drug: megestrol acetate Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks. Other Names: Megace

Arm

Intervention/Treatment

Experimental: Subjects that respond to Periactin

Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.

Drug: cyproheptadine hydrochloride

Other Names:

Periactin

Experimental: Non-responders to Periactin- Megace Arm

Drug: cyproheptadine hydrochloride

Other Names:

Periactin

Drug: megestrol acetate

Other Names:

Megace

Outcome Measures

Primary Outcome Measures

Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment [4-8 weeks]

Secondary Outcome Measures

Effect of study agents on protein and fat levels as measured by pre-albumin and lipid profile at baseline, and 4 weeks after the beginning of study treatment [4-8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:

Any cachectic patient with weight loss presumed secondary to cancer or cancer related therapy is eligible. Cachexia is defined as having one or more of the following:
documented history of weight loss > 5%
drop in growth rate two or more percentile ranks on standard growth charts,
weight for height less than the tenth percentile.
Patients with newly diagnosed or relapsed cancer of any type, including brain tumors.
Patients who are receiving active or palliative therapy are eligible.
If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy) within 8 weeks of study registration, they are also eligible.
Patients must be ≥ 2 years and < 21 years of age at the time of admission to this study.
Patients must have a predicted life expectancy of at least eight weeks.

EXCLUSION CRITERIA:

Patients who are currently taking or who have taken Periactin and/or Megace during the past three weeks are not eligible.
Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy. (Intermittent steroid use is permitted IF you anticipate it will not be administered for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid use in 4-week intervals through the 8-week period during which study agent may be administered (4 weeks for Periactin and potentially 4 weeks for Megace.
Patients who have received parenteral nutrition or tube feedings within 1 week of starting this protocol or patients who are expected to require parenteral nutrition or tube feedings during the 4-week course of this study.
Patients taking dronabinol (Marinol) or other appetite-stimulating medications during the past three weeks or patients expected to be prescribed appetite-stimulating medications during the 4-week course of this study.
Patients with hormone sensitive tumors specifically meningiomas, breast cancer, ovarian cancer, and endometrial carcinoma.31, 32
Children with neurofibromatosis, type I or II, are at risk for the development of meningiomas and are thus excluded from this study.32
Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) or genitourinary (GU) obstruction.
Patients with recurrent and/or persistent hypertension, defined as blood pressure values >20% above normal.
Patients with thromboembolic disease, congestive heart failure, or peripheral edema.
Patients who are pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609-3305
2	Children's Hospital & Research Center Oakland	Oakland	California	United States	94609
3	Children's National Medical Center	Washington	District of Columbia	United States	20010-2970
4	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610-0296
5	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
6	Sacred Heart Cancer Center at Sacred Heart Hospital	Pensacola	Florida	United States	32504
7	All Children's Hospital	St. Petersburg	Florida	United States	33701
8	St. Joseph's Children's Hospital of Tampa	Tampa	Florida	United States	33677-4227
9	CCOP - Florida Pediatric	Tampa	Florida	United States	33682-7757
10	Kaplan Cancer Center at St. Mary's Medical Center	West Palm Beach	Florida	United States	33407
11	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912-4000
12	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
13	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
14	Children's Hospital of New Orleans	New Orleans	Louisiana	United States	70118
15	Floating Hospital for Children at Tufts - New England Medical Center	Boston	Massachusetts	United States	02111
16	Van Elslander Cancer Center at St. John Hospital and Medical Center	Detroit	Michigan	United States	48236
17	DeVos Children's Hospital	Grand Rapids	Michigan	United States	49503
18	CCOP - Beaumont	Royal Oak	Michigan	United States	48073-6769
19	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
20	Children's Hospitals and Clinics of Minnesota - Minneapolis	Saint Paul	Minnesota	United States	55106-2049
21	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
22	Tomorrows Children's Institute at Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
23	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
24	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
25	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
26	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
27	Children's Hospital Medical Center of Akron	Akron	Ohio	United States	44308-1062
28	Columbus Children's Hospital	Columbus	Ohio	United States	43205-2696
29	Children's Medical Center - Dayton	Dayton	Ohio	United States	45404-1815
30	Tod Children's Hospital	Youngstown	Ohio	United States	44501
31	Legacy Emanuel Hospital and Health Center & Children's Hospital	Portland	Oregon	United States	97227
32	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
33	CHRISTUS Santa Rosa Children's Hospital	San Antonio	Texas	United States	78207
34	MBCCOP - South Texas Pediatrics	San Antonio	Texas	United States	78229-3900
35	Methodist Cancer Center at Methodist Specialty and Transplant Hospital	San Antonio	Texas	United States	78229-3902
36	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
37	Vermont Cancer Center at University of Vermont	Burlington	Vermont	United States	05405-0110
38	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia	United States	23298-0121
39	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington	United States	98105-3916
40	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-9070
41	Montreal Children's Hospital at McGill University Health Center	Montreal	Quebec	Canada	H3G 1A4
42	Hopital Sainte Justine	Montreal	Quebec	Canada	H3T 1C5
43	San Jorge Children's Hospital	Santurce		Puerto Rico	00912