Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT00808899
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Temsirolimus — DRUG
    Temsirolimus
  • Irinotecan — DRUG
    Irinotecan
  • Surgical Resection of Primary Tumor — PROCEDURE
    Surgical Resection of Primary Tumor
  • Cyclophosphamide — DRUG
    Cyclophosphamide
  • Doxorubicin — DRUG
    Doxorubicin
  • Etoposide — DRUG
    Etoposide
  • Cisplatin — DRUG
    Cisplatin
  • Topotecan — DRUG
    Topotecan
  • PBSC — PROCEDURE
    Peripheral Blood Stem Cell Harvest
  • Radiation Therapy — RADIATION
    Radiation Therapy
  • 13-cis-retinoic acid — DRUG
    13-cis-retinoic acid

Study Details

A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan; cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and topotecan (TPT) followed by and additional six courses of induction chemotherapy and then intensification with autologous hematopoietic stem cell transplantation. The first five courses of induction chemotherapy will also evaluate the feasibility of combining weekly temsirolimus with these standard chemotherapy combinations. This will be followed by 16 months of oral maintenance therapy with eight months of 13-cis-retinoic acid and then eight months of oral topotecan.

Key Dates

Start date
Dec 31, 2008
Status verified
May 2010
Primary completion
Jul 31, 2009
Completion
Jul 31, 2009

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Fixed doses of IV temsirolimus concomitantly with two courses of fixed dosages of irinotecan, 2 days off, repeated daily 5 times.If initial dosages are not tolerable, subsequent patients will be given a reduced dosage of temsirolimus with irinotecan.If this dosage combination is not tolerable,irinotecan dosage will be decreased.If this dosage combination is not tolerable.Further enrollment to initial six week treatment will be terminated.Second course of irinotecan will begin on day 22, response will be determined after six weeks. Resection of primary tumor will be attempted after initial therapy.Following initial treatment children will undergo alternating courses of induction chemotherapy with cyclophosphamide,doxorubicin,etoposide,topotecan, and cisplatin.First cohort of 17 patients will receive Block 2 with temsirolimus for all three courses, weekly 2 times.If this is not tolerated subsequent patients will receive Block 2 chemotherapy with reduced dosages of temsirolimus.

Primary Outcome Measure

Complete Response Plus Partial Response [ Time Frame: 10 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105-

Find similar trials in Memphis, TN

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
St. Jude Children's Research Hospital· Memphis, TN

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