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Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers

Primary Purpose

Wilms Tumor, Fibrosarcoma, Carcinoma, Round Cell

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Myeloablative Chemotherapy
Stem Cell Rescue
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wilms Tumor

Eligibility Criteria

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

Inclusion Criteria: Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor, which: is metastatic and has < 25% cure rate with conventional treatment; or progressed after prior chemotherapy and has < 25% salvage rate with non-myeloablative therapies. Disease status: Within 3 weeks of initiation of this protocol, patients must: be in a complete or good partial remission (section 7.4); or have a "chemosensitive" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy, without evidence of progressive disease by any other parameter. Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy. Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue. The cancer must be proven to be sensitive to alkylating agents. This means that, in addition to, or as part of, the appropriate chemotherapy protocol for the specific cancer in question, all patients must have received and responded to a minimum of: 2 courses of high-dose cyclophosphamide, totaling > 4200 mg/m2; or courses of high-dose ifosfamide totaling > 12 gm/m2. 1 course of "a)" above, plus 1 course of 'b)" above. Equivalent high dose alkylating agents as described in 3.3 a, b, and c. Patients must have adequate renal hepatic, and cardiac function (sections 4.4-4.6). Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option): Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or, Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg. Informed consent must be signed indicating patient and/or parental awareness of the investigational nature of this program

Sites / Locations

  • The University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Myeloablative Chemotherapy with Stem Cell Rescue

Arm Description

Myeloablative Chemotherapy, followed by stem cell rescue

Outcomes

Primary Outcome Measures

Percent of Participants With Progression Free Survival at 1 Year
The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2005
Last Updated
May 19, 2014
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00141765
Brief Title
Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers
Official Title
Myeloablative Chemotherapy With Stem Cell Rescue for Rare Poor-Prognosis Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether very high dosages of chemotherapy will improve the chance of surviving cancer.
Detailed Description
This is a phase II trial designed to provide a transplant option for patients with rare poor-prognosis cancers. The protocol is only open to patients with metastatic or relapsed cancers for whom the probability of remaining free of progressive disease for one year after being brought into remission is < 25%. Patients eligible for this study have been diagnosed with a form of cancer that leads to death more than 75% of the time when treated with standard therapy doses of chemotherapy and/ or radiation therapy. Under this treatment intensification protocol the expectation is that the one year progression-free survival for this group of patients will rise to 40%. Patients eligible for this protocol will be followed for one year post-transplant. Patients alive and free of progressive disease at the end of this period will be considered successes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wilms Tumor, Fibrosarcoma, Carcinoma, Round Cell, Nasopharyngeal Cancer, Brain Tumor, Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myeloablative Chemotherapy with Stem Cell Rescue
Arm Type
Experimental
Arm Description
Myeloablative Chemotherapy, followed by stem cell rescue
Intervention Type
Procedure
Intervention Name(s)
Myeloablative Chemotherapy
Intervention Description
High dose chemotherapy (carboplatin and thiotepa) transplant rescue
Intervention Type
Procedure
Intervention Name(s)
Stem Cell Rescue
Intervention Description
autologous stem cell transplantation
Primary Outcome Measure Information:
Title
Percent of Participants With Progression Free Survival at 1 Year
Description
The primary outcome measure for this study was to improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse.
Time Frame
1 year post transplant

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be ineligible for other IRB-approved myeloablative regimens, be 21 years old or younger, and must have a histologically-confirmed Wilms' tumor, liver cancer, recurrent brain tumor of childhood, nasopharyngeal carcinoma, fibrosarcoma, desmoplastic small round cell tumor, germ cell tumor or other small round cell tumor, which: is metastatic and has < 25% cure rate with conventional treatment; or progressed after prior chemotherapy and has < 25% salvage rate with non-myeloablative therapies. Disease status: Within 3 weeks of initiation of this protocol, patients must: be in a complete or good partial remission (section 7.4); or have a "chemosensitive" tumor, which is defined as a > 50% decrease in at least one measurable tumor parameter attributable to prior chemotherapy, without evidence of progressive disease by any other parameter. Prior chemotherapy: Before entry to this protocol, patients must have derived maximal benefit from conventional, i.e., nonmyeloablative, doses of combination chemotherapy. Conventional therapy should be continued until either a complete remission is achieved, no further benefit from non-myeloablative dosing can be appreciated, or toxicity from conventional therapy is perceived as limiting in the absence of stem cell rescue. The cancer must be proven to be sensitive to alkylating agents. This means that, in addition to, or as part of, the appropriate chemotherapy protocol for the specific cancer in question, all patients must have received and responded to a minimum of: 2 courses of high-dose cyclophosphamide, totaling > 4200 mg/m2; or courses of high-dose ifosfamide totaling > 12 gm/m2. 1 course of "a)" above, plus 1 course of 'b)" above. Equivalent high dose alkylating agents as described in 3.3 a, b, and c. Patients must have adequate renal hepatic, and cardiac function (sections 4.4-4.6). Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option): Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or, Peripheral blood collection should include at least 2 x 106 CD34+ cells/kg. Informed consent must be signed indicating patient and/or parental awareness of the investigational nature of this program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E. Levine, MS MD
Organizational Affiliation
The Univeristy of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers

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