Status:
COMPLETED
Ranibizumab for Neurofibromas Associated With Neurofibromatosis 1
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Neurofibromatosis Type 1
Cutaneous Neurofibromas
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this research study is to determine if ranibizumab can prevent the growth of neurofibromas. We will also be collecting extra blood and serum samples to help us learn more about NF1. Ran...
Detailed Description
* Participants will receive one injection of ranibizumab into 3 tumors on their skin (one dose per tumor) on day 1 of treatment. One other tumor will be injected with normal saline solution. The salin...
Eligibility Criteria
Inclusion
- Patients must have diagnosis of NF1 based on NIH criteria with two or more of the following characteristics: a) Six or more cafe-au-lait macules b) Skin fold freckling in the axilla or groin c) Optic pathway glioma d) Two or more Lisch nodules of the iris e) Distinctive bony lesions such as dysplasia of the sphenoid wing or of a long bone such as the tibia f) Two or more neurofibromas of any type or 1 or more plexiform neurofibroma g) First degree relative with NF1
- At least four cutaneous neurofibromas on skin exam with the following qualities: a) the lesion must be discrete by clinical exam and must be at least 5mm away from another skin tumor b) the lesion must be amenable to measurement with calipers with minimum dimension of 5mm and maximum dimension of 20mm c)the lesions cannot be located on the face, scalp, or groin and must be located in an area that can be photographed d) histologic confirmation of tumor type is not required in the setting of compatible clinical setting
- Must be willing to have treated CNF surgically removed during the study
- 18 years of age or older
- Normal organ and marrow function as described in the protocol
Exclusion
- Pregnant or breast-feeding women
- Chemotherapy or radiotherapy within 6 weeks prior to entering the study
- Receiving any other investigational agent
- History of allergic reactions attributed to compounds of similar chemical or biologic composition as ranibizumab
- Hypertension that cannot be controlled by medications
- Known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhages in the past
- NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Uncontrolled intercurrent illness
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00657202
Start Date
March 1 2008
End Date
December 1 2013
Last Update
July 7 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114