Esther! What a ride! But such a good landing ;o)
You may want to save this info, for a 'just in case' future reference, as I have done:
Trial Information
Summary: hCRF’s potential for steroid-sparing in symptomatic brain tumor patients with peritumoral edema.
If you have a malignant brain tumor and require chronic high doses of dexamethasone (also known as Decadron) to control your neurological symptoms, you may be eligible to participate in a study of
XERECEPT™ for patients with brain tumors and tumor-associated swelling.
The purpose of this study is to compare the safety and efficacy of XERECEPT™ to dexamethasone, a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms who may suffer from the steroid’s side effects.
Patients will be assigned by chance (like flipping a coin) to 1 of 2 treatment groups: XERECEPT™ or placebo.
A placebo is an inactive substance that looks like the study drug but has no medication treatment effect. The placebo is used in this study to help determine if the effects experienced by study patients are specific to XERECEPT™ or just the result of participating in a treatment setting.
If you participate in this study, you will:
Continue your dexamethasone, but gradually reduce your dose by 50% or more
Make 8 visits over 16 weeks to your study physician for physical and neurological evaluations
Administer hCRF (or its matching placebo) 2 times daily for 12 weeks by injection under the skin--the injections may alternatively be administered by somebody other than you whom you have chosen. The research nurse will teach you or the person you have chosen how to give the injections at home.
Take by mouth 1 tablet of niacin or its matching placebo twice daily
Call a toll-free phone number daily to record your dosing of study drugs
Inclusion Criteria:
Primary or metastatic malignant brain tumor
Steroid-associated side effect(s)
Taking dexamethasone for at least 30 days to control symptoms of edema.
Stable dexamethasone dose of 8-24 mg/day for at least 14 days prior to starting study
Karnofsky score of >= 50
Capable of self-administration of subcutaneous injections twice daily for 12 weeks, or availability of assistance from family/friend.
Life expectancy of at least 4 months
Ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed consent
For women of childbearing potential: a negative serum pregnancy test
18 years of age or older.
Exclusion Criteria:
Need for surgery, radiosurgery or radiation therapy or new chemotherapeutic regime during the first 5 weeks of study. Treatment with pre-study chemotherapy may continue.
Concurrent enrollment in any other investigational drug or device study, or plan to enroll in such a study during the first 5 weeks of treatment.
Systemic steroid use for any indication other than peritumoral brain edema.
Use of dexamethasone to prevent vomiting. (Alternatives such as Compazine, Anzemet, Zofran and Kytril may be considered.)
Non-cooperation with dexamethasone or anticonvulsant therapy.
Cerebral herniation.
Serious cardiovascular, pulmonary, renal, gastrointestinal or endocrine metabolic disease which would put the patient at unusual risk for study participation (Patients may receive gastrointestinal prophylactic treatment.)
Previous or current neurological disorders that would interfere with adequate clinical evaluation
Clinically significant head injury or chronic seizure disorder, if the condition results in functional impairment or is likely to interfere with evaluations (Maintenance anticonvulsant therapy is allowed.)
Central nervous system infection
Pregnancy, breastfeeding and/or refusal to practice birth control while in study, for women of childbearing potential
Any conditions that are considered contraindications for niacin, e.g. liver disease, active peptic ulcer, arterial hemorrhage, asthma and known hypersensitivity to niacin
For more information about this trial, go to:
http://www.ntii.com/products/clinicaltrials.shtml.
Memorial Sloan-Kettering Cancer Center
A Phase III Study of Human Corticotropin-Releasing Factor (hCRF) for Controlling Symptoms of Brain Edema in Patients with Brain Cancer who Need Dexamethasone
[Protocol 04-102]
Full Title :
PH III RANDOMIZED, DOUBLE-BLIND, DEXAMETHASONE-SPARING STDY COMPARING HUMAN CORTICOTROPIN-RELEASING FACTOR(HCRF)TO PLACEBO FOR CONTROL SYMPTOMS ASSOC W/ PERITUMORAL BRAIN EDEMA PTS W/ MALIG BRAIN TUM WHO REQUIRE CHRONIC ADMIN HIGH-DOSE DEXAMETHASONE
Purpose :
Patients with primary brain cancer or metastases in the brain (cancer that has spread there from elsewhere in the body) may experience swelling (edema) in the brain that can cause disabling neurological symptoms. High doses of a steroid drug called dexamethasone (Decadron®) are often used to relieve edema, but dexamethasone can cause side effects, such as muscle wasting, excessive weight gain, osteoporosis, and mood changes.
In this phase III trial, investigators at Memorial Sloan-Kettering Cancer Center want to determine if human CRF (hCRF), an investigational drug, may reduce brain edema in patients with malignant brain tumors who need dexamethasone, thereby decreasing symptoms. Human CRF is a hormone made in the human brain. The hCRF used in this study is a manmade product that is the same as the hCRF that occurs naturally in the body.
Researchers want to see if using hCRF can reduce a patient's need for dexamethasone, thereby reducing the side effects associated with this steroid. Patients will be randomly assigned to receive hCRF or a placebo.
Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
Patients must have primary brain cancer or brain metastases causing edema that must be treated with high doses of dexamethasone. Patients must be experiencing at least one side effect associated with dexamethasone.
Patients who need surgery, radiosurgery, radiation therapy, or a new chemotherapy regimen during the first 5 weeks of the study may not participate. Chemotherapy that began before entry into the study may continue.
Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Adilia Hormigo at 212-639-7330 or Dr. Lauren Abrey at 212-639-5122.
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