Status:
WITHDRAWN
Clofarabine for Langerhans in Pedi
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Langerhans Cell Histiocytosis
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigat...
Detailed Description
If you are willing to participate in this research study you will be asked to undergo some screening test or procedure to find out if you are eligible. Many of these tests and procedures are likely to...
Eligibility Criteria
Inclusion
- Have failed first line treatment with prednisone and vinblastine
- Clinical evidence of involvement of hematopoietic system, liver or spleen
- Have failed salvage treatment with cladribine/cytarabine or are not considered to be eligible for such treatment
- Willing to use effective contraception during study and for six months after study treatment
- Adequate marrow and organ function
Exclusion
- Pregnant or breastfeeding
- Have received chemotherapy or radiotherapy within 2 weeks of study entry
- Have not recovered from adverse events due to previously administered agents
- Receiving other study agents
- Taking drugs with known renal toxicity
- Use of alternative medicine during study treatment
- Uncontrolled intercurrent illness
- History of a different malignancy except if disease-free for at least five years or within five years for cervical cancer in situ and basal and squamous cell carcinoma of the skin
- Known to be HIV positive on antiretroviral therapy
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01796405
Last Update
August 25 2015
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