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

Primary Purpose

Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
carboplatin
thiotepa
topotecan hydrochloride
autologous bone marrow transplantation
bone marrow ablation with stem cell support
in vitro-treated bone marrow transplantation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Germ Cell Tumor focused on measuring 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

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 20, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00002515
Brief Title
Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer
Official Title
Myeloablative Chemotherapy With Bone Marrow Rescue For Rare Poor-Prognosis Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 1992 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Intervention Type
Procedure
Intervention Name(s)
in vitro-treated bone marrow transplantation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian H. Kushner, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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