Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002515
First received: November 1, 1999
Last updated: December 3, 2011
Last verified: May 2005
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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 |
|---|---|---|
|
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 |
Biological: filgrastim Drug: carboplatin 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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers |
Resource links provided by NLM:
MedlinePlus related topics:
Bone Marrow Transplantation
Cancer
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lymphoma
Neuroblastoma
Ovarian Cancer
Soft Tissue Sarcoma
Wilms' Tumor
Drug Information available for:
Thiotepa
Carboplatin
Topotecan hydrochloride
Filgrastim
Topotecan
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | October 1992 |
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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002515 History of Changes |
| Other Study ID Numbers: | CDR0000078115, MSKCC-92148, NCI-V93-0214 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 3, 2011 |
| 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 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 |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Head and Neck Neoplasms Liver Neoplasms Lymphoma Neuroblastoma Ovarian Neoplasms Retinoblastoma Neoplasms, Germ Cell and Embryonal Sarcoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Digestive System Neoplasms Digestive System Diseases Liver Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial |
ClinicalTrials.gov processed this record on May 23, 2013