Skip to content

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002515
Enrollment
Unknown
Registered
2003-01-27
Start date
1992-10-31
Completion date
2005-04-30
Last updated
2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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, 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

Brief summary

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.

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.

Interventions

BIOLOGICALfilgrastim
DRUGcarboplatin
DRUGthiotepa
DRUGtopotecan hydrochloride
PROCEDUREautologous bone marrow transplantation
PROCEDUREbone marrow ablation with stem cell support

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026