Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
Condition: Brain Tumor; Central Nervous System Tumors; Cachexia; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Neoplasms; Leukemia; Preleukemia; Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Wasting Syndrome; Syndrome; Cachexia
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): cyproheptadine hydrochloride; megestrol acetate
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Periactin; Megace
Intervention MeSH terms: Cyproheptadine; Megestrol; Megestrol Acetate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: 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