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17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia Clinical research trials and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia clinical trial. Participants typically obtain the most effective healthcare available for their 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "1" Clinical Trials Conditions > 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia  17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
For Condition: acute undifferentiated leukemia,recurrent childhood acute myeloid leukemia,unspecified childhood solid tumor, protocol specific,recurrent childhood acute lymphoblastic leukemia,secondary acute myeloid leukemia
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of 17-N-allylamino-17-demethoxygeldanamycin in treating young patients who have relapsed or refractorysolid tumors or leukemia.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose and recommended phase II dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in pediatric patients with relapsed or refractory solid tumors or leukemia. - Determine the toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. Secondary - Determine, preliminarily, the antitumor activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients with solid tumors receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 60 minutes on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 6 additional patients with leukemia receive 17-AAG at the MTD as above. If these 6 patients tolerate this regimen, another 6 leukemia patients receive 17-AAG IV over 60 minutes on days 1, 4, 8, 11, 15, and 18. Treatment repeats every 28 days for 17 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days. PROJECTED ACCRUAL: A maximum of 36 (3-24 with solid tumors and 12 with leukemia) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of solid tumor or leukemia with documented M3 marrow - Histologic confirmation of intrinsic brain stem tumors not required - Relapsed or refractory disease - No known curative therapy - In patients with CNS tumors, neurologic deficits must be stable for at least the past week PATIENT CHARACTERISTICS: Age - 1 to 21 Performance status - Karnofsky 50-100% (>10 years of age) - Lansky 50-100% ( 10 years of age) Life expectancy - Not specified Hematopoietic - For patients with solid tumors: - Absolute neutrophil count 1,000/mm^3 - Platelet count 100,000/mm^3 (transfusion independent) - Hemoglobin 8.0 g/dL (may receive RBC transfusions) - For patients with leukemia: - Platelet count 20,000/mm^3 (may receive platelet transfusions) - Hemoglobin 8.0 g/dL (may receive RBC transfusions) Hepatic - Bilirubin 1.5 times upper limit of normal (ULN) - ALT 2.5 times ULN - Albumin 2 g/dL Renal - Creatinine clearance OR radioisotope glomerular filtration rate 70 mL/min OR - Creatinine based on age as follows: - 0.8 mg/dL if 5 years of age - 1.0 mg/dL if > 5 years and 10 years of age - 1.2 mg/dL if > 10 years and 15 years of age - 1.5 mg/dL if > 15 years and 21 years of age Other - No uncontrolled infection - No prior severe allergy to eggs - No situation that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 7 days (or window for adverse effects has passed) since prior biologic therapy and recovered - At least 7 days since prior hematopoietic growth factors - At least 2 months since prior stem cell transplantation and no evidence of graft-vs-host disease - No concurrent hematopoietic growth factors - No concurrent biologic therapy - No concurrent immunotherapy Chemotherapy - At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered - No other concurrent chemotherapy Endocrine therapy - No concurrent steroid therapy Radiotherapy - At least 2 weeks since prior local palliative radiotherapy (small port) - At least 3 months since prior total body irradiation or craniospinal radiotherapy - At least 3 months since prior radiotherapy to 50% of the pelvis - At least 6 weeks since prior substantial bone marrow radiotherapy - Recovered from prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - No other concurrent investigational drugs - No other concurrent anticancer agents - No concurrent administration of medications known to be metabolized by the CYP4503A isoenzyme
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrendaWeigel, Study Chair, University of Minnesota Cancer Center
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
State University of New York Health Science Center at Brooklyn College of Medicine *Recruiting*
Brooklyn, New York, 11203
United States
Recruiting Sreedhar Rao 718-270-1693
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Nita Seibel 202-884-2144
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Arthur Ritchey 412-692-5949
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Beverly Lange 215-590-2249
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Douglas Hawkins 206-987-3096
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Albert Moghrabi 514-345-4969
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Neyssa Marina 650-723-5535
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-2511
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Susan Blaney 832-822-1482
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Robert Fallon 317-274-8784
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Linda Granowetter 212-305-8652
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Contact Person 888-NCI-1937
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
Doernbecher Children's Hospital at Oregon Health & Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting H. Nicholson 503-494-1543
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Joseph Neglia 612-626-2778
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting John Perentesis 513-636-6090
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Victor Blanchette 416-598-5852
Additional Information:
Study ID Numbers: CDR0000355714; COG-ADVL0316
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079404
Other Secondary Acute Myeloid Leukemia Studies:
1. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
2. Filgrastim-Treated Donor Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia
3. Bone Marrow Transplantation in Treating Patients With Acute Leukemia in First or Second Remission
4. Combination Chemotherapy Plus Steroid Therapy in Treating Children With Acute Lymphoblastic Leukemia or Lymphoblastic Non-Hodgkin's Lymphoma
5. Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
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17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
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