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Phase II Prospective Study of Sequential Myeloablative Chemotherapy With Stem Cell Rescue for the Treatment of Selected High Risk CNS Tumors and Recurrent CNS Tumors

Phase 2/Phase 3
18 Months
25 Years
Open (Enrolling)
Glioblastoma, Astrocytoma, Pineoblastoma, Rhabdoid Tumor, Supratentorial Neoplasms

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Trial Information

Phase II Prospective Study of Sequential Myeloablative Chemotherapy With Stem Cell Rescue for the Treatment of Selected High Risk CNS Tumors and Recurrent CNS Tumors

Inclusion Criteria:

- Patient's age must be greater than (>) 18 months and less than or equal to (≤) 25
years at the time of diagnosis or recurrence.

- Neuroradiographic evidence of a recurrent posterior fossa medulloblastoma or
recurrent CNS germ cell tumor.

- The presence of a histologically confirmed high grade astrocytoma, GBM, rhabdoid
tumor, supratentorial PNET, or pineoblastoma either at the time of diagnosis or

- Patients must be brought to state of minimum residual disease by surgical reduction
and/or chemotherapy and/or radiation therapy or a combination of above prior to
myeloablative chemotherapy and tandem stem cell rescue.

- Documentation of chemotherapy sensitivity is required for enrollment.
Chemotherapy-sensitive tumors are defined as those tumors which have had a reduction
of 50% after 2-4 cycles of chemotherapy (CTX or platinum). For patients with no
evidence of disease post resection, continued complete remission after 2-4 cycles of
chemotherapy defines chemosensitivity.

- Adequate physiologic function, defined as follows:

- creatinine clearance > 70 ml/minutes/1.73 m2.

- SGPT < 10 x normal and bilirubin < 10 mg/dl.

- Adequate complete blood count (CBC): hemoglobin > 10 gm/dl, absolute neutrophil
count (ANC) > 1500/ul, and platelets > 100,000/ul.

- Informed consent. The patient and/or the patient's legally authorized guardian must
acknowledge in writing that consent to become a study subject has been obtained, in
accordance with institutional policies provided by the United States (U.S.)
Department of Health and Human Services.

- Protocol approval. Approval for the use of this institution's Human Rights Committee
must be obtained in accordance with the institutional assurance policies of the U. S.
Department of Health and Human Services.

- Patients with high-risk medulloblastoma after initial surgery.

- To allow non-English speaking patients to participate in this study, bilingual health
care services will be provided in the appropriate language.

Exclusion Criteria:

- Patients with brain stem glioma are ineligible.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if the use of sequential myeloablative chemotherapy with peripheral blood stem cell rescue will increase the overall survival rate in patients with newly diagnosed high risk CNS tumors

Outcome Time Frame:

To end of study

Safety Issue:


Principal Investigator

Stewart Goldman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago


United States: Institutional Review Board

Study ID:

BMT 0398



Start Date:

March 1998

Completion Date:

Related Keywords:

  • Glioblastoma
  • Astrocytoma
  • Pineoblastoma
  • Rhabdoid Tumor
  • Supratentorial Neoplasms
  • brain tumor
  • medulloblastoma
  • germ cell tumor
  • CNS tumor
  • glioblastoma
  • astrocytoma
  • pineoblastoma
  • rhabdoid tumor
  • supratentorial PNET
  • high grade astrocytoma
  • Astrocytoma
  • Neoplasms
  • Glioblastoma
  • Supratentorial Neoplasms
  • Pinealoma
  • Rhabdoid Tumor



Children's Memorial Hospital Chicago, Illinois  60614