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


Phase 2
2 Years
20 Years
Not Enrolling
Both
Brain Tumor, Central Nervous System Tumors, Cachexia, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

4-8 weeks

Safety Issue:

No

Principal Investigator

Jennifer L. Mayer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Data and Safety Monitoring Board

Study ID:

SCUSF 0205

NCT ID:

NCT00066248

Start Date:

June 2003

Completion Date:

April 2008

Related Keywords:

  • Brain Tumor
  • Central Nervous System Tumors
  • Cachexia
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • cachexia
  • unspecified childhood solid tumor
  • childhood spinal cord neoplasm
  • recurrent childhood medulloblastoma
  • untreated childhood medulloblastoma
  • childhood high-grade cerebral astrocytoma
  • childhood low-grade cerebral astrocytoma
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • untreated childhood cerebellar astrocytoma
  • childhood oligodendroglioma
  • recurrent childhood brain stem glioma
  • recurrent childhood visual pathway glioma
  • hypothalamic glioma
  • untreated childhood brain stem glioma
  • untreated childhood visual pathway
  • childhood supratentorial primitive neuroectodermal tumor
  • childhood craniopharyngioma
  • childhood infratentorial ependymoma
  • childhood supratentorial ependymoma
  • newly diagnosed childhood ependymoma
  • recurrent childhood ependymoma
  • childhood choroid plexus tumor
  • childhood central nervous system germ cell tumor
  • childhood acute lymphoblastic leukemia in remission
  • recurrent childhood acute lymphoblastic leukemia
  • untreated childhood acute lymphoblastic leukemia
  • childhood acute myeloid leukemia in remission
  • recurrent childhood acute myeloid leukemia
  • untreated childhood acute myeloid leukemia
  • other myeloid malignancies
  • refractory chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • juvenile myelomonocytic leukemia
  • recurrent/refractory childhood Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • stage II childhood Hodgkin lymphoma
  • stage III childhood Hodgkin lymphoma
  • stage IV childhood Hodgkin lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • progressive hairy cell leukemia, initial treatment
  • refractory hairy cell leukemia
  • untreated hairy cell leukemia
  • recurrent childhood lymphoblastic lymphoma
  • stage I childhood lymphoblastic lymphoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • stage I childhood small noncleaved cell lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • stage I childhood large cell lymphoma
  • stage II childhood large cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent childhood brain tumor
  • atypical chronic myeloid leukemia
  • myelodysplastic/myeloproliferative disease
  • childhood chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • chronic myelomonocytic leukemia
  • Brain Neoplasms
  • Cachexia
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Nervous System Neoplasms
  • Lymphoma, Non-Hodgkin
  • Central Nervous System Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
CCOP - Florida PediatricTampa, Florida  33682-7757
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Nemours Children's ClinicJacksonville, Florida  32207
All Children's HospitalSt. Petersburg, Florida  33701
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
Tod Children's HospitalYoungstown, Ohio  44501
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Methodist Cancer Center at Methodist Specialty and Transplant HospitalSan Antonio, Texas  78229-3902
MBCCOP - South Texas PediatricsSan Antonio, Texas  78229-3900
St. Joseph's Children's Hospital of TampaTampa, Florida  33677-4227
DeVos Children's HospitalGrand Rapids, Michigan  49503
Columbus Children's HospitalColumbus, Ohio  43205-2696
Children's Hospital & Research Center OaklandOakland, California  94609
Tomorrows Children's Institute at Hackensack University Medical CenterHackensack, New Jersey  07601
CHRISTUS Santa Rosa Children's HospitalSan Antonio, Texas  78207