ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

17-N-Allylamino-17-Demethoxygeldanamycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors

This study is currently recruiting patients.

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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 recurrent or refractory leukemia or selected solid tumors.

Condition Treatment or Intervention Phase
Ewing's family of tumors
childhood rhabdomyosarcoma
childhood soft tissue sarcoma
hematopoietic and lymphoid cancer
Neuroblastoma
Osteosarcoma
 Drug: 17-N-allylamino-17-demethoxygeldanamycin
 Procedure: chemotherapy
Phase I

MedlinePlus related topics:  Blood and Blood Disorders;   Bone Cancer;   Cancer;   Cancer Alternative Therapy;   Neuroblastoma;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Pediatric Patients With Recurrent or Refractory Leukemia or Selected Solid Tumors

Further Study Details: 

OBJECTIVES: Primary

Secondary

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to diagnosis (leukemia vs solid tumor).

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11 (for patients with solid tumors) OR days 1, 4, 8, 11, 14, and 18 (for patients with leukemia). Courses for all patients repeat every 21 days 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 3 or 2 of 6 patients experience dose-limiting toxicity. At least 15 patients are treated at the MTD.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 70 patients (35 per stratum) will be accrued for this study within 23.3-35 months.

Eligibility

Ages Eligible for Study:  up to  21 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

Performance status

Life expectancy

Hematopoietic

Hepatic

Renal

Cardiovascular

Pulmonary

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

Chemotherapy

Endocrine therapy

Radiotherapy

Surgery

Other


Location and Contact Information


Arizona
      Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson,  Arizona,  85724,  United States; Recruiting
Rochelle Bagatell, MD  520-626-4851 

      Phoenix Children's Hospital, Phoenix,  Arizona,  85016,  United States; Recruiting
Jessica Boklan, MD  602-546-0920 

Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80218,  United States; Recruiting
Lia Gore, MD, FAAP  303-315-8251    lia.gore@uchsc.edu 

Florida
      Shands Cancer Center at the University of Florida Health Science Center, Gainesville,  Florida,  32610-0296,  United States; Recruiting
Stephen P. Hunger, MD  352-392-5633    hungersp@peds.ufl.edu 

Georgia
      AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus, Atlanta,  Georgia,  30322,  United States; Recruiting
Howard M. Katzenstein, MD  404-727-4451 

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-7223,  United States; Recruiting
Robert J. Arceci, MD, PhD  410-502-7519    arcecro@jhmi.edu 

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Tanya Trippett, MD  212-639-8267 

Tennessee
      Vanderbilt Children's Hospital, Nashville,  Tennessee,  37232-6310,  United States; Recruiting
James A. Whitlock, MD  615-936-1762 

Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States; Recruiting
Cynthia Herzog, MD  713-745-0157    cherzog@mdanderson.org 

Study chairs or principal investigators

Tanya Trippett, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000391010; MSKCC-04069; NCI-6323; POETIC-MSKCC-04069
Record last reviewed:  September 2004
Record first received:  October 6, 2004
ClinicalTrials.gov Identifier:  NCT00093821
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act