Study of High-Dose Chemotherapy With Bone Marrow or Stem Cell Transplant for Rare Poor-Prognosis Cancers
Condition: Wilms Tumor; Fibrosarcoma; Carcinoma, Round Cell; Nasopharyngeal Cancer; Brain Tumor, Recurrent
MeSH terms: Brain Neoplasms; Wilms Tumor; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Fibrosarcoma
Intervention: Myeloablative Chemotherapy; Stem Cell Rescue
Intervention description: High dose chemotherapy (carboplatin and thiotepa) transplant rescue; autologous stem cell transplantation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

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

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:

               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