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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00066248
First received: August 6, 2003
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Leukemia, Myeloid Chronic Myeloid Leukemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Acute Lymphoblastic Leukemia Lymphosarcoma Acute Myeloid Leukemia, Childhood Lymphoma, Large-cell Myelodysplastic Syndromes Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Lymphoblastic Lymphoma Brain Stem Glioma, Childhood Glioma Hodgkin Lymphoma Acute Lymphoblastic Leukemia, Childhood Small Non-cleaved Cell Lymphoma Hodgkin Lymphoma, Childhood Chronic Myelomonocytic Leukemia Children's Interstitial Lung Disease Medulloblastoma Myelodysplastic/myeloproliferative Disease Hairy Cell Leukemia Juvenile Myelomonocytic Leukemia Oligodendroglioma Anaplastic Oligodendroglioma Ependymoma Neuroepithelioma Supratentorial Primitive Neuroectodermal Tumor Medulloblastoma, Childhood Cerebellar Astrocytoma, Childhood Cerebral Astrocytoma, Childhood Pineoblastoma, Childhood Supratentorial Primitive Neuroectodermal Tumors, Childhood Optic Pathway Glioma Central Nervous System Lymphoma, Primary Spinal Cord Neoplasm Brain Tumor, Childhood Craniopharyngioma Chronic Myeloproliferative Disorders
U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment [ Time Frame: 4-8 weeks ] [ Designated as safety issue: No ]

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 [ Time Frame: 4-8 weeks ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: June 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Megace

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.

  Eligibility

Ages Eligible for Study:   2 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066248

  Show 43 Study Locations
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Jennifer L. Mayer, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00066248     History of Changes
Other Study ID Numbers: SCUSF 0205, HLMCC-0205, U10CA081920, SCUSF 0205
Study First Received: August 6, 2003
Last Updated: January 31, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government

Keywords provided by University of South Florida:
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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Lymphoma
Leukemia
Syndrome
Neoplasms
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Cachexia
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight

ClinicalTrials.gov processed this record on September 29, 2014