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Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer

This study has been completed.

Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002515
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with thiotepa, carboplatin, and topotecan followed by bone marrow transplantation in treating patients who have metastatic or progressive rare cancer.


Condition Intervention Phase
Bone Marrow Ablation
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lymphoma
Neuroblastoma
Ovarian Cancer
Retinoblastoma
Sarcoma
Testicular Germ Cell Tumor
Drug: carboplatin
Drug: filgrastim
Drug: thiotepa
Drug: topotecan hydrochloride
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: in vitro-treated bone marrow transplantation
Phase II

Genetics Home Reference related topics:   retinoblastoma   

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Head and Neck Cancer    Kidney Cancer    Liver Cancer    Lymphoma    Neuroblastoma    Ovarian Cancer    Soft Tissue Sarcoma   

ChemIDplus related topics:   Carboplatin    Filgrastim    Thiotepa    Topotecan hydrochloride    Topotecan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 1992

Detailed Description:

OBJECTIVES:

  • Improve the long term disease-free survival of patients with rare cancers at high risk for lethal relapse by using myeloablative chemotherapy with thiotepa, carboplatin, and topotecan followed by autologous bone marrow or peripheral blood stem cell rescue.

OUTLINE: Autologous bone marrow or peripheral blood stem cells (PBSC) are harvested. Patients receive high-dose thiotepa IV over 3 hours on days -8 to -6, carboplatin IV over 4 hours on days -5 to -3, and topotecan IV over 30 minutes on days -8 to -4. Autologous bone marrow or PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) IV twice daily beginning on day 1.

Patients are followed for 1 year.

PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study within 5 years.

  Eligibility
Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy of one of the following types:

    • Wilms' tumor
    • Liver cancer
    • Desmoplastic or other small round cell tumor
    • Nasopharyngeal carcinoma
    • Fibrosarcoma
  • Disease that has metastasized and has a cure rate of no greater than 25% with conventional treatment or disease that has progressed after prior chemotherapy, was not then surgically resectable, and has a salvage rate with nonmyeloablative therapies of no greater than 25% required
  • Maximal benefit from conventional (nonmyeloablative) doses of combination chemotherapy required prior to entry, and it is recommended that patients have received a minimum of one of the following:

    • 2 courses of high-dose cyclophosphamide (as per protocol MSKCC-90062)
    • 2 courses of high-dose ifosfamide/etoposide (as in the poor-risk sarcoma protocol MSKCC-90071A)
    • 1 course of high-dose cyclophosphamide plus 1 course of high-dose ifosfamide/etoposide
  • Within 3 weeks of initiation of protocol therapy, patients must be:

    • In CR or good PR OR
    • Tumor considered "chemosensitive", i.e., a 50% or greater decrease in at least 1 measurable tumor parameter attributable to prior chemotherapy without evidence of progressive disease by any other parameter
  • Ineligible for other IRB-approved myeloablative regimens
  • No evidence of current bone marrow involvement on bone marrow aspiration (x4) and biopsy (x2)

PATIENT CHARACTERISTICS:

Age:

  • 21 and under

Performance status:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 1.5 times ULN
  • 5'-Nucleotidase no greater than 1.5 times ULN

Renal:

  • Creatinine normal
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • CPK normal
  • Echocardiogram (or RNCA) normal
  • EKG normal

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002515

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center    
      New York, New York, United States, 10021

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center

Investigators
Study Chair:     Brian H. Kushner, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000078115, MSKCC-92148, NCI-V93-0214
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002515
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chondrosarcoma  
recurrent childhood rhabdomyosarcoma  
stage IV childhood liver cancer  
recurrent neuroblastoma  
recurrent childhood liver cancer  
recurrent Wilms tumor and other childhood kidney tumors  
stage IV Wilms tumor  
recurrent retinoblastoma  
stage IV childhood lymphoblastic lymphoma  
recurrent childhood lymphoblastic lymphoma  
recurrent osteosarcoma  
stage IV ovarian germ cell tumor  
recurrent malignant testicular germ cell tumor  
childhood germ cell tumor  
alveolar childhood rhabdomyosarcoma  
recurrent childhood soft tissue sarcoma
recurrent ovarian germ cell tumor
childhood fibrosarcoma
extragonadal germ cell tumor
bone marrow ablation
childhood desmoplastic small round cell tumor
recurrent childhood small noncleaved cell lymphoma
stage IV childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
stage IV childhood large cell lymphoma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx

Study placed in the following topic categories:
Retinal Neoplasms
Fibrosarcoma
Liver Diseases
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Urogenital Neoplasms
Retinoblastoma
Urologic Neoplasms
Small non-cleaved cell lymphoma
Osteogenic sarcoma
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Neuroepithelioma
Kidney Diseases
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Lymphoma, Large B-Cell, Diffuse
Digestive System Neoplasms
Immunoproliferative Disorders
Eye Neoplasms
Genital Neoplasms, Female
Endocrine System Diseases
Carboplatin
Renal cancer
Testicular Neoplasms
Thiotepa
Carcinoma
Neuroectodermal Tumors
Sarcoma
Gastrointestinal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Neoplasms, Neuroepithelial
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on September 19, 2008




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