|
|
|
|
|
Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025038 |
RATIONALE: Giving chemotherapy drugs, such as R115777, isotretinoin, cytarabine, and fludarabine, before a donor bone marrow transplant or an umbilical cord transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with donor bone marrow or umbilical cord blood transplant works in treating children with newly diagnosed juvenile myelomonocytic leukemia.
Condition | Intervention | Phase |
Leukemia |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cytarabine Drug: fludarabine phosphate Drug: isotretinoin Drug: tipifarnib Procedure: allogeneic bone marrow transplantation Procedure: radiation therapy Procedure: umbilical cord blood transplantation |
Phase II |
MedlinePlus related topics: | Bone Marrow Transplantation Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
ChemIDplus related topics: | Cyclophosphamide Cytarabine Cytarabine hydrochloride Fludarabine Fludarabine monophosphate Isotretinoin Tretinoin Tipifarnib |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Window Evaluation of the Farnesyl Transferase Inhibitor (R115777) Followed by 13-CIS Retinoic Acid, Cytosine Arabinoside and Fludarabine Plus Hematopoietic Stem Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia |
Estimated Enrollment: | 100 |
Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients may choose to receive upfront window induction therapy with oral R115777 twice daily on days 1-21. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with progressive disease or stable disease with unacceptable hematopoietic recovery after 1 course proceed to induction chemotherapy. (R11577 portion of the study closed to accrual as of 08/2005)
All patients receive induction chemotherapy comprising oral isotretinoin once daily beginning on day 1 and fludarabine IV over 30 minutes and cytarabine IV over 4 hours on days 1-5. Treatment with fludarabine and cytarabine repeats every 28 days for 2 courses. Treatment with isotretinoin continues until allogeneic bone marrow or umbilical cord blood transplantation. Patients with progressive disease after 1 course proceed to transplantation.
After completion of isotretinoin, patients receive a preparative regimen comprising total body irradiation twice daily on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, and anti-thymocyte globulin IV over 4-6 hours every 12 hours on days -3 to -1.
Patients undergo allogeneic bone marrow or umbilical cord blood transplantation on day 0. Patients receive oral isotretinoin daily beginning on approximately day 60 and continuing for 1 year.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 100 patients (18-46 receiving R115777 with induction chemotherapy [R11577 portion of the study closed to accrual as of 08/2005] and 27-54 receiving induction chemotherapy only) will be accrued for this study within 3.2 years.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Presenting with all of the following:
Presenting with at least 2 of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Show 105 Study Locations |
Children's Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Robert P. Castleberry, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Castleberry RP, Loh ML, Jayaprakash N, et al.: Phase II window study of the farnesyltransferase inhibitor R115777 (Zarnestra®) in untreated juvenile myelomonocytic leukemia (JMML): a Children's Oncology Group Study. [Abstract] Blood 106 (11): A-2587, 2005.
  |
Study ID Numbers: | CDR0000068788, COG-AAML0122 |
First Received: | October 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00025038 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|