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Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
sargramostim
cyclophosphamide
thiotepa
autologous bone marrow transplantation
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
Sponsored by
Herbert Irving Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent adult brain tumor, adult medulloblastoma, adult glioblastoma, adult oligodendroglioma, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult mixed glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood ependymoma, adult giant cell glioblastoma, adult gliosarcoma, adult supratentorial primitive neuroectodermal tumor (PNET)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma Primary or recurrent glioblastoma multiforme (including gliosarcoma) following surgery and radiotherapy or prior conventional chemotherapy (e.g., carmustine or procarbazine, vincristine, and lomustine) Recurrent or refractory anaplastic astrocytoma following any prior therapy (must be chemoresistant) Recurrent or refractory ependymoma or primitive neuroectodermal tumor (PNET) following any prior therapy Recurrent or refractory oligodendroglioma or oligoastrocytoma following any prior therapy (must be chemoresistant) Evaluable disease on gadolinium-enhanced MRI Ineligible for other high priority national or institutional study (e.g., protocol CAMP-004) PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 times normal Cardiovascular: LVEF at least 45% by MUGA Pulmonary: DLCO at least 60% of predicted OR Approval by pulmonologist Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy No concurrent steroids as antiemetics Radiotherapy: See Disease Characteristics See Surgery Surgery: See Disease Characteristics For patients with glioblastoma multiforme, concurrent surgery and/or stereotactic radiosurgery to reduce tumor bulk allowed Other: No concurrent acetaminophen during chemotherapy

Sites / Locations

  • St. Joseph's Hospital and Medical Center
  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Outcomes

Primary Outcome Measures

Response rate
Disease-free interval
Overall survival
Toxicity

Secondary Outcome Measures

Pharmacokinetics
Presence of high-dose thiotepa in the cerebrospinal fluid

Full Information

First Posted
January 6, 2001
Last Updated
February 1, 2013
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00008008
Brief Title
Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma
Official Title
CAMP 013:- Tandem Thiotepa Regimen For Selected Malignant Gliomas:1) Primary Or Recurrent Glioblastoma Multiforme (GBM); and 2) Recurrent Anaplastic Astrocytomas (AA), Oligodendrogliomas (O), Oligoastrocytomas (OA), Ependymomas And Primitive Neuroectodermal Tumors (PNET) That Have Either Progressed After Primary Therapy Or Are Refractory To Standard Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well thiotepa followed by peripheral stem cell or bone marrow transplant works in treating patients with malignant glioma.
Detailed Description
OBJECTIVES: Determine the response rate, disease-free interval, and overall survival of patients with malignant glioma treated with high-dose thiotepa followed by autologous peripheral blood stem cell transplantation. Determine the toxicity of this regimen in these patients. Determine the pharmacokinetics of this regimen in these patients. Determine whether this drug enters the cerebrospinal fluid of these patients. OUTLINE: Following a course of induction chemotherapy with cyclophosphamide IV over 4 hours, patients receive filgrastim (G-CSF) daily until the completion of peripheral blood stem cell (PBSC) harvesting. PBSCs are collected over 3-5 days. Patients who do not mobilize sufficient cells undergo bone marrow harvest. Patients receive high-dose thiotepa IV over 5 hours on day -2. PBSCs or bone marrow are reinfused on day 0. Patients receive sargramostim (GM-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover. Treatment repeats every 2-3 weeks for a total of 1-4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at every course, then monthly for 6 months, and then every 2 months thereafter. Patients are followed monthly for 6 months and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 5-40 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent adult brain tumor, adult medulloblastoma, adult glioblastoma, adult oligodendroglioma, childhood high-grade cerebral astrocytoma, childhood oligodendroglioma, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult mixed glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood ependymoma, adult giant cell glioblastoma, adult gliosarcoma, adult supratentorial primitive neuroectodermal tumor (PNET)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Primary Outcome Measure Information:
Title
Response rate
Title
Disease-free interval
Title
Overall survival
Title
Toxicity
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Title
Presence of high-dose thiotepa in the cerebrospinal fluid

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma Primary or recurrent glioblastoma multiforme (including gliosarcoma) following surgery and radiotherapy or prior conventional chemotherapy (e.g., carmustine or procarbazine, vincristine, and lomustine) Recurrent or refractory anaplastic astrocytoma following any prior therapy (must be chemoresistant) Recurrent or refractory ependymoma or primitive neuroectodermal tumor (PNET) following any prior therapy Recurrent or refractory oligodendroglioma or oligoastrocytoma following any prior therapy (must be chemoresistant) Evaluable disease on gadolinium-enhanced MRI Ineligible for other high priority national or institutional study (e.g., protocol CAMP-004) PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 times normal Cardiovascular: LVEF at least 45% by MUGA Pulmonary: DLCO at least 60% of predicted OR Approval by pulmonologist Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy No concurrent steroids as antiemetics Radiotherapy: See Disease Characteristics See Surgery Surgery: See Disease Characteristics For patients with glioblastoma multiforme, concurrent surgery and/or stereotactic radiosurgery to reduce tumor bulk allowed Other: No concurrent acetaminophen during chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles S. Hesdorffer, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma

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