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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


Phase 2
N/A
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Charles S. Hesdorffer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068362

NCT ID:

NCT00008008

Start Date:

September 1997

Completion Date:

May 2008

Related Keywords:

  • Brain and Central Nervous System Tumors
  • 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)
  • Astrocytoma
  • Ependymoma
  • Glioblastoma
  • Glioma
  • Nervous System Neoplasms
  • Oligodendroglioma
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive

Name

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