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Sponsored by: |
University of Michigan Cancer Center |
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Information provided by: | University of Michigan Cancer Center |
ClinicalTrials.gov Identifier: | NCT00141765 |
The purpose of this study is to determine whether very high dosages of chemotherapy will improve the chance of surviving cancer.
Condition | Intervention | Phase |
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Wilms Tumor Fibrosarcoma Carcinoma, Round Cell Nasopharyngeal Cancer Brain Tumor, Recurrent |
Procedure: Myeloablative Chemotherapy Procedure: Stem Cell Rescue |
Phase II |
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 |
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) |
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.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Disease status: Within 3 weeks of initiation of this protocol, patients must:
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:
Patients must meet at least one of the following stem cell requirements (Peripheral blood collection is to be preferred when available as an option):
Contact: John E. Levine, MS MD | 734-936-8785 |
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 |
Principal Investigator: | John E. Levine, MS MD | The Univeristy of Michigan |
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 |
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 |
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 |