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NCT Number: NCT00002515

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

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.

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Key information

Conditions

Childhood Germ Cell Tumor Adnexal Diseases Burkitt Lymphoma Chondrosarcoma Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Desmoplastic Small Round Cell Tumor Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Epstein-Barr Virus Infections Extragonadal Germ Cell Tumor Eye Diseases Eye Diseases, Hereditary Eye Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosarcoma Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Hemic and Lymphatic Diseases Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Infections Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Syndromes, Hereditary Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Osteosarcoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Retinal Diseases Retinal Neoplasms Retinoblastoma Sarcoma Testicular Diseases Testicular Germ Cell Tumor Testicular Neoplasms Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Virus Diseases Wilms Tumor

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

carboplatin

Drug

Thiotepa

Drug

Topotecan Hydrochloride

Drug

autologous bone marrow transplantation

Procedure

bone marrow ablation with stem cell support

Procedure

in vitro-treated bone marrow transplantation

Procedure

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers

Important dates

Study start
1992
Primary completion
2005
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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