Clofarabine for Langerhans in Pedi

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different diseases. It also means that the FDA has not yet approved clofarabine for your disease.

Clofarabine is a chemotherapy drug that has been used in the treatment of leukemia in children and adults. Information from other research studies suggests that this drug may also be effective in patients with LCH.

The purpose of this study is to estimate the response rates of participants with recurrent LCH to clofarabine within each of two strata: a) low-risk participants with disease reactivation, and b) high-risk participants with risk-organ involvement.

Other purposes are to estimate the progression-free survival after clofarabine treatment, estimate survival of participants with refractory multi-system LCH with risk organ involvement treated with clofarabine and to describe toxicities of clofarabine in participants with LCH.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Treatments: Clofarabine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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