Status:
COMPLETED
Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Wilms Tumor
Fibrosarcoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00141765
Start Date
January 1 1997
End Date
February 1 2010
Last Update
June 20 2014
Active Locations (1)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109