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Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This research study is evaluating a drug called clofarabine as a possible treatment for Langerhans Cell Histiocytosis( LCH )

Details

This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational intervention, to learn whether the drug works in treating a specific disease, in this case, clofarabine to treat LCH.

"Investigational" means that the intervention is still being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved clofarabine for your disease.

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

Keywords

Langerhans Cell Histiocytosis Clofarabine

Eligibility

You can join if…

  • Prior diagnosis of Langerhans Cell Histiocytosis established by standard diagnostic criteria and confirmed histologically
  • Evidence of disease reactivation or progression after standard treatment against LCH(histological confirmation is not required)
  • Performance Score> 70% (use Lansky score for age < 16 and Karnofsky score for age =

    16).

  • Patients of all ages will be eligible.
  • Provide signed written informed consent.
  • Patients have failed first line treatment with prednisone and vinblastine. There is no limitation of amount or the type of prior therapy or drugs.
  • Patients with 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.
  • Female patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment. Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
  • Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
  • Participants must have adequate marrow functions as defined below, except those with involvement of hematopoietic system for whom these criteria can be waived:
  • Absolute neutrophil count ≥ 750/µL
  • Platelets ≥75,000/µL
  • Participants must have adequate organ functions as defined below:
  • Total bilirubin ≤ 2.5x institutional upper limit of normal
  • AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal unless it is related to involvement by LCH
  • Adequate renal function defined as:
  • A serum creatinine ≤ institutional upper limit of normal or
  • Creatinine clearance or radioisotope GFR ≥60 mL/min/1.73 m2
  • Alkaline phosphatase ≤ 2.5 x institutional upper limit of normal

You CAN'T join if...

  • Participants who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
  • Participants may not be receiving any other investigational agents targeting LCH.
  • Use of alternative medications (e.g., herbal or botanical that could interfere with clofarabine) is not permitted during the entire study period.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because clofarabine has potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants, breastfeeding should be discontinued if the mother is treated with clofarabine.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years:cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  • Patients with a history of prior hematopoietic stem cell transplantation(HSCT),elevated conjugated serum bilirubin at study entry, uncontrolled systemic fungal,bacterial, or other infection, a history of hepatitis B or C infection or a history of cirrhosis.
  • Individuals who are known to be HIV-positive on combination antiretroviral therapy.

Locations

  • Texas Children's Hospital accepting new patients
    Houston, Texas, 77030, United States
  • St. Jude Children's Research Hospital accepting new patients
    Memphis, Tennessee, 38105, United States
  • Cincinnati Children's Hospital Medical Center accepting new patients
    Cincinnati, Ohio, 45229, United States
  • Mount Sinai Medical Center accepting new patients
    New York, New York, 10029, United States
  • Boston Children's Hospital accepting new patients
    Boston, Massachusetts, 02115, United States
  • Dana-Farber Cancer Institute accepting new patients
    Boston, Massachusetts, 02115, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dana-Farber Cancer Institute
ID
NCT02425904
Phase
Phase 2
Lead Scientist
Michelle Hermiston
Study Type
Interventional
Last Updated
April 1, 2017
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