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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075634 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as decitabine, doxorubicin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of decitabine when given together with doxorubicin and cyclophosphamide in treating children with relapsed or refractory solid tumors or neuroblastoma.
| Condition | Intervention | Phase |
|
Neuroblastoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: cyclophosphamide Drug: decitabine Drug: doxorubicin hydrochloride Drug: filgrastim Drug: pegfilgrastim |
Phase I |
| MedlinePlus related topics: | Cancer Neuroblastoma |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Filgrastim Pegfilgrastim 5-Aza-2'-deoxycytidine |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Study of Decitabine (NSC #127716, IND #50733) in Combination With Doxorubicin and Cyclophosphamide in the Treatment of Relapsed or Refractory Solid Tumors |
| Estimated Enrollment: | 21 |
| Study Start Date: | December 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of decitabine.
Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
NOTE: *For patients > 45 kg
Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 15-21 patients will be accrued for this study within 1-2 years.
Eligibility
| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of either of the following:
Solid tumor (part A)
Neuroblastoma (part B)
Accessible disease by bone marrow aspirate or tumor biopsy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Parts A and B without bone marrow infiltration:
Part B with bone marrow infiltration (i.e., tumor metastatic to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia):
Hepatic
Renal
Creatinine based on age as follows:
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 6 months since prior allogeneic bone marrow transplantation
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |||||
| Stanford Comprehensive Cancer Center at Stanford University Medical Center | |||||
| Stanford, California, United States, 94305 | |||||
| United States, District of Columbia | |||||
| Children's National Medical Center | |||||
| Washington, District of Columbia, United States, 20010-2970 | |||||
| United States, Indiana | |||||
| Indiana University Cancer Center | |||||
| Indianapolis, Indiana, United States, 46202-5289 | |||||
| United States, Massachusetts | |||||
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| United States, Minnesota | |||||
| Mayo Clinic Cancer Center | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| University of Minnesota Medical Center - Fairview | |||||
| Minneapolis, Minnesota, United States, 55455 | |||||
| United States, Mississippi | |||||
| University of Mississippi Medical Center | |||||
| Jackson, Mississippi, United States, 39216-4505 | |||||
| United States, New York | |||||
| Herbert Irving Comprehensive Cancer Center at Columbia University | |||||
| New York, New York, United States, 10032 | |||||
| SUNY Upstate Medical University Hospital | |||||
| Syracuse, New York, United States, 13210 | |||||
| United States, Ohio | |||||
| Cincinnati Children's Hospital Medical Center | |||||
| Cincinnati, Ohio, United States, 45229-3039 | |||||
| United States, Oregon | |||||
| Oregon Health & Science University Cancer Institute | |||||
| Portland, Oregon, United States, 97239-3098 | |||||
| United States, Pennsylvania | |||||
| Children's Hospital of Philadelphia | |||||
| Philadelphia, Pennsylvania, United States, 19104-9786 | |||||
| Children's Hospital of Pittsburgh | |||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| United States, Tennessee | |||||
| St. Jude Children's Research Hospital | |||||
| Memphis, Tennessee, United States, 38105 | |||||
| United States, Texas | |||||
| Baylor University Medical Center - Houston | |||||
| Houston, Texas, United States, 77030-2399 | |||||
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |||||
| Dallas, Texas, United States, 75390 | |||||
| United States, Washington | |||||
| Children's Hospital and Regional Medical Center - Seattle | |||||
| Seattle, Washington, United States, 98105 | |||||
| Canada, Ontario | |||||
| Hospital for Sick Children | |||||
| Toronto, Ontario, Canada, M5G 1X8 | |||||
| Canada, Quebec | |||||
| Hopital Sainte Justine | |||||
| Montreal, Quebec, Canada, H3T 1C5 | |||||
| Children's Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Rani E. George, MD, PhD | Dana-Farber Cancer Institute |
| Investigator: | Lisa Diller, MD | Dana-Farber Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
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George R, Lahti J, Ingle M, et al.: Decitabine (DAC) in combination with doxorubicin (DOX) and cyclophosphamide (CTX) in relapsed neuroblastoma (NBL): a Children's Oncology Group study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9565, 542s, 2007.
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George RE, Medeiros-Nancarrow C, Adamson PC, et al.: A phase I study of decitabine (DCT) in combination with doxorubicin (DOX) and cyclophosphamide (CTX) in the treatment of relapsed or refractory solid tumors - a Children's Oncology Group study. [Abstract] J Clin Oncol 23 (Suppl 16): A-8530, 807s, 2005.
  |
| Study ID Numbers: | CDR0000347393, COG-ADVL0215 |
| First Received: | January 9, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00075634 |
| Health Authority: | United States: Federal Government |
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