Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.
2. Determine the toxicity of this regimen in these patients.
3. Determine the pharmacokinetics of this regimen in these patients.
4. Determine whether this drug enters the cerebrospinal fluid of these patients.

Entry 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)

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

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

Expected Enrollment

A total of 5-40 patients will be accrued for this study within 3 years.

Outcomes

Response rate
Disease-free interval
Overall survival
Toxicity

Pharmacokinetics
Presence of high-dose thiotepa in the cerebrospinal fluid

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Charles Hesdorffer, MD, Protocol chair		Ph: 212-305-4907 Email: csh1@columbia.edu

Registry Information
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
Trial Start Date		1997-09-10
Trial Completion Date		2005-06-01
Registered in ClinicalTrials.gov		NCT00008008
Date Submitted to PDQ		2000-11-08
Information Last Verified		2007-07-11
NCI Grant/Contract Number		CA13696

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