Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers
This study is currently recruiting participants.
Verified by University of Michigan Cancer Center, July 2008
Sponsored by: University of Michigan Cancer Center
Information provided by: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00141765
  Purpose

The purpose of this study is to determine whether very high dosages of chemotherapy will improve the chance of surviving cancer.


Condition Intervention Phase
Wilms Tumor
Fibrosarcoma
Carcinoma, Round Cell
Nasopharyngeal Cancer
Brain Tumor, Recurrent
Procedure: Myeloablative Chemotherapy
Procedure: Stem Cell Rescue
Phase II

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors Wilms' Tumor
Drug Information available for: Carboplatin Thiotepa
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Myeloablative Chemotherapy With Stem Cell Rescue for Rare Poor-Prognosis Cancers

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • To improve the long-term disease-free survival of patients with rare cancers at high risk for lethal relapse. [ Time Frame: subject's lifetime ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 1997
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Myeloablative Chemotherapy
    High dose chemotherapy (carboplatin and thiotepa)transplant rescue
    Procedure: Stem Cell Rescue
    autologous stem cell transplantation
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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    1. is metastatic and has < 25% cure rate with conventional treatment; or
    2. 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:

    1. be in a complete or good partial remission (section 7.4); or
    2. 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:

    1. 2 courses of high-dose cyclophosphamide, totaling > 4200 mg/m2; or
    2. courses of high-dose ifosfamide totaling > 12 gm/m2.
    3. 1 course of "a)" above, plus 1 course of 'b)" above.
    4. 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):

    1. Harvested bone marrow must contain 1 x 108 nucleated cells per kg of body weight, or,
    2. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141765

Contacts
Contact: John E. Levine, MS MD 734-936-8785

Locations
United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer AnswerLine     800-865-1125        
Contact: Cancer AnswerLine     1-800-865-1125        
Principal Investigator: John E. Levine, MS MD            
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: John E. Levine, MS MD The Univeristy of Michigan
  More Information

Responsible Party: University of Michigan Health System ( John Levine, M.D. )
Study ID Numbers: UMCC 9626, IRB 1996-195
Study First Received: August 31, 2005
Last Updated: July 25, 2008
ClinicalTrials.gov Identifier: NCT00141765  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Thoracic Neoplasms
Fibrosarcoma
Otorhinolaryngologic Neoplasms
Carcinoma, Neuroendocrine
Malignant mesenchymal tumor
Pharyngeal Neoplasms
Urogenital Neoplasms
Central Nervous System Neoplasms
Kidney cancer
Brain Diseases
Urologic Neoplasms
Soft tissue sarcomas
Nasopharyngeal Neoplasms
Neoplasms, Connective and Soft Tissue
Respiratory Tract Diseases
Urologic Diseases
Lung Neoplasms
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Wilms Tumor
Kidney Diseases
Nervous System Neoplasms
Otorhinolaryngologic Diseases
Wilms' tumor
Central Nervous System Diseases
Carboplatin
Renal cancer
Pharyngeal Diseases
Recurrence

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nasopharyngeal Diseases
Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue
Neoplasms, Complex and Mixed

ClinicalTrials.gov processed this record on January 13, 2009