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Phase II Study of Cyproheptadine and Megestrol in Preventing Further Weight Loss In Children with Cancer or Cancer Treatment-Related Cachexia
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
Basic Trial Information
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Phase II

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Supportive care

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Completed

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2 to 20

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MCC-0205 NCT00066248

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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.
Entry Criteria Disease Characteristics:
- Newly diagnosed or relapsed cancer of any type, including brain tumors
- Cachexia with weight loss presumed secondary to cancer or cancer-related treatment defined as 1 or more of the following:
- Documented weight loss of at least 5%
- Drop in growth rate 2 or more percentile ranks on standard growth charts
- Weight for height less than the tenth percentile
- No hormone-sensitive tumors (i.e., meningiomas, breast cancer, ovarian cancer, or endometrial cancer)
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - No more than 8 weeks since prior chemotherapy
Endocrine therapy - No concurrent corticosteroids except intermittent steroid use (≤ 7 days in a 4 week period)
Radiotherapy - No more than 8 weeks since prior radiotherapy
Surgery - No more than 8 weeks since prior surgery
- Concurrent tumor-debulking surgery, limb-sparing surgery, or amputation allowed
Other - More than 3 weeks since prior cyproheptadine or megestrol
- More than 3 weeks since prior dronabinol or other appetite-stimulating medications
- More than 1 week since prior parenteral nutrition or tube feedings
- No more than 8 weeks since prior other anticancer therapy
- No other concurrent appetite-stimulating medications
- No concurrent parenteral nutrition or tube feedings
- No concurrent monoamine oxidase inhibitors (e.g., moclobemide, phenelzine, or tranylcypromine)
- Concurrent active or palliative therapy allowed
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal Cardiovascular - No thromboembolic disease
- No congestive heart failure
- No recurrent or persistent hypertension (i.e., blood pressure values greater than 20% above normal)
Other - Not pregnant or nursing
- Fertile patients must use effective contraception
- No type I or II neurofibromatosis
- No glaucoma
- No chronic persistent asthma
- No gastrointestinal or genitourinary obstruction
- No peripheral edema
Expected Enrollment 70A total of 70 patients will be accrued for this study. Outcomes Primary Outcome(s)Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment
Secondary Outcome(s)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
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 cyprohepatadine or megestrol may continue treatment at the discretion of the treating physician. Patients are followed at 4 weeks.
Trial Contact Information
Trial Lead Organizations H. Lee Moffitt Cancer Center CCOP Research Base  |  |  | | Jennifer Mayer, MD, Protocol chair |  | |  |
| Registry Information |  | | Official Title | | The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children with Cancer/Treatment Related Cachexia |  | | Trial Start Date | | 2003-06-30 |  | | Trial Completion Date | | 2007-12-10 |  | | Registered in ClinicalTrials.gov | | NCT00066248 |  | | Date Submitted to PDQ | | 2003-05-22 |  | | Information Last Verified | | 2007-05-06 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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