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Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Neuroblastoma and Sarcomas

Primary Purpose

Neuroblastoma, Ewings Sarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vincristine
Cyclophosphamide
Adriamycin
Etoposide (VP-16)
Cisplatin
Carboplatin
Melphalan
Ifosfamide
G-CSF (granulocyte-colony stimulating factor)
Mesna
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring Stem cell transplant, High-risk pediatric tumors

Eligibility Criteria

undefined - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Previously untreated neuroblastoma Stage D > 365 days Previously untreated neuroblastoma Stage C at age > 365 days with n-myc amplification Previously untreated metastatic Ewings sarcoma/PNET Previously untreated non-rhabdomyosarcoma soft tissue sarcoma Confirmation of neuroblastoma at time of diagnosis by histologic specimen or with bone marrow specimen showing solid tumor. Confirmation of sarcoma by histologic specimen with evidence of metastatic disease be imaging study Patient 19 years of age or younger ANC > 1000 Platelet count > 75,000 SGOT < 2.5 x ULN Normal serum creatinine levels for age Exclusion Criteria: Previous malignancy requiring nonsurgical treatment or bone marrow transplant. Relapsed disease

Sites / Locations

  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

To determine the toxicity and feasibility of double dose chemo-radiotherapy with blood progenitor cell rescue in this patient population.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
October 30, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Boston Children's Hospital, Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT00165139
Brief Title
Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Neuroblastoma and Sarcomas
Official Title
Double Dose Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Stage Neuroblastoma and Sarcomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Boston Children's Hospital, Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to determine the short and long term side effects of a very intensive treatment, which includes combinations of chemotherapy drugs followed by radiation therapy and two transplants supported by peripheral blood progenitor cells (stem cells), for children with advanced stage neuroblastoma and sarcomas.
Detailed Description
The treatment is separated into three stages: 1) Initial treatment-chemotherapy and stem cell collection; 2) Treatment targeted directly to the main tumor-surgery and radiation therapy; 3) Intensified treatment: two stem cell transplants. Patients will receive intensive treatment with a combination of seven drugs which will be given every 3 weeks, or as soon as the patient's blood counts are within safe limits. A total of 5 or 6 courses of chemotherapy will be given. The third and fourth course will be followed by stem cell collections and the last course will be followed by bone marrow harvest in preparation for transplant. The first treatment involves a high-dose of Cisplatin intravenously once a day for 5 days and VP-16 intravenously on days 2,3 and 4 of the treatment. The second course of treatment involves cyclophosphamide intravenously on day 1 and day 2, adriamycin intravenously continuously over 48 hours, and vincristine intravenously on day 1. The third course of treatment involves ifosfamide daily on days 1-5 and VP-16 on days 1-3. Mesna will also be given to prevent bladder irritation. During the fourth course patients will receive, carboplatin intravenously on days 1 and 2 and VP-16 on days 1,2 and 3 of treatment. The fifth course of treatment will be identical to the second course. G-CSF (granulocyte colony-stimulating factor) stimulates bone marrow to produce more white blood cells and will be given subcutaneously until the patients' white blood cell counts are at an acceptable level. This may require 10-14 days of G-CSF treatment. After the first two treatments, and after the last course of treatment, patients will be evaluated for response. If significant tumor is still present in the bone marrow before the third treatment, stem cell collection will be delayed. If the bone marrow still shows disease after the next treatment, this plan of treatment will be stopped. Patients may undergo surgery after the last treatment to remove the tumor and to evaluate the remaining disease. After recovery, radiation therapy may be performed to the main tumor area. Patients will receive transplantations of stem cells twice during this study. After each preparative treatment, half of the patient's stored stem cells will be given intravenously. Until the stem cells restore safe levels of blood cells, the patient will be hospitalized (3-4 weeks or longer). The first treatment will begin with high doses of carboplatin and VP-16 daily for 3 consecutive days followed by cyclophosphamide on the fourth and fifth days. Between 4-6 weeks after the start of the first course of high dose chemotherapy a second course consisting of melphalan and total body irradiation (TBI) will be given. Melphalan will be given daily for 3 consecutive days followed by TBI twice a day for 3 days. After each of the two high dose treatments outlined above, the stem cells that were previously harvested from the patient will be given back to them through a central line. Stem cells will be collected on 3 separate occasions following each of two cycles of chemotherapy. They will then be processed using a technique that attempts to separate stem cells from other cells, including any cancer cells that may be present. Bone marrow will also be harvested prior to the first transplant and will be used if blood counts do not recover after the stem cells are given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma, Ewings Sarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma
Keywords
Stem cell transplant, High-risk pediatric tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Described under detailed description
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Described under detailed description
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Description
Described under detailed description
Intervention Type
Drug
Intervention Name(s)
Etoposide (VP-16)
Intervention Description
Described under detailed description
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Described under detailed description
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Described under detailed description
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
Described under detailed description
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Description
Described under detailed description
Intervention Type
Drug
Intervention Name(s)
G-CSF (granulocyte-colony stimulating factor)
Intervention Description
Described under detailed description
Intervention Type
Drug
Intervention Name(s)
Mesna
Intervention Description
Described under detailed description
Primary Outcome Measure Information:
Title
To determine the toxicity and feasibility of double dose chemo-radiotherapy with blood progenitor cell rescue in this patient population.
Time Frame
5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previously untreated neuroblastoma Stage D > 365 days Previously untreated neuroblastoma Stage C at age > 365 days with n-myc amplification Previously untreated metastatic Ewings sarcoma/PNET Previously untreated non-rhabdomyosarcoma soft tissue sarcoma Confirmation of neuroblastoma at time of diagnosis by histologic specimen or with bone marrow specimen showing solid tumor. Confirmation of sarcoma by histologic specimen with evidence of metastatic disease be imaging study Patient 19 years of age or younger ANC > 1000 Platelet count > 75,000 SGOT < 2.5 x ULN Normal serum creatinine levels for age Exclusion Criteria: Previous malignancy requiring nonsurgical treatment or bone marrow transplant. Relapsed disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Diller, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Intensive Chemo-Radiotherapy With Peripheral Blood Progenitor Cell Rescue for Children With Advanced Neuroblastoma and Sarcomas

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