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

Sponsor:	Herbert Irving Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00008008

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer

Drug Information available for: Cyclophosphamide Thiotepa Granulocyte-macrophage colony-stimulating factor Filgrastim Sargramostim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]
Disease-free interval [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Designated as safety issue: No ]
Presence of high-dose thiotepa in the cerebrospinal fluid [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 1997
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008008

Locations

United States, New Jersey
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

Herbert Irving Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles S. Hesdorffer, MD

Herbert Irving Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00008008 History of Changes
Other Study ID Numbers:	CDR0000068362, CPMC-IRB-8017, CPMC-CAMP-013, NCI-G00-1883
Study First Received:	January 6, 2001
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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)

Additional relevant MeSH terms:

Astrocytoma
Ependymoma
Glioblastoma
Glioma
Nervous System Neoplasms
Oligodendroglioma
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

Neoplasms by Site
Nervous System Diseases
Cyclophosphamide
Thiotepa
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 13, 2012