Phosphorus 32 in Treating Patients With Glioblastoma Multiforme - Full Text View

Sponsored by:	Center for Molecular Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004129

Purpose

RATIONALE: Radioactive drugs such as phosphorus 32 may be able to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of phosphorus 32 in treating patients with glioblastoma multiforme.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Radiation: brachytherapy Radiation: phosphorus P32	Phase I

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Chromic phosphate P 32 Phosphorus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I/II Study of Interstitial Colloidal 32P for the Treatment of Recurrent Malignant Central Nervous System Tumors and Primary Central Nervous System Tumors With Poor Prognostic Factors

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

Estimated Enrollment:	12
Study Start Date:	September 1999

Detailed Description:

OBJECTIVES:

Determine the dosimetry toxicity of interstitial colloidal phosphorus P32 (C P32) in patients with recurrent or poor prognosis grade 4 astrocytoma.
Determine the maximum tolerated dose of C P32 administered directly into the tumor of these patients.
Determine the maximum tolerated fractionated dose of interstitial C P32 in these patients.
Determine the therapeutic response rate to the acceptable single and fractionated doses of C P32 in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive interstitial colloidal phosphorus P32 (C P32) on day 0. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3 patients receive escalating doses of C P32 until the maximum tolerated dose (MTD) is determined. The MTD is defined the dose at which 2 of 3 patients experience dose-limiting toxicity.

Patients are followed at 1, 2, 4, 6, 9, 15, and 24 weeks.

PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven grade 4 astrocytoma (glioblastoma)
- Failed external beam radiotherapy and/or surgery OR
- Poor prognosis disease
No clinical evidence of metastatic disease within the CNS other than the primary tumor site
Stereotactic biopsy or gross total excision with residual tumor
Lesion 3 to 5 cm in size
No spinal cord tumor(s)

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 70-100%

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm3
Neutrophil count at least 1,900/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic:

Not specified

Renal:

Creatinine no greater than 1.5 mg/dL
BUN less than 25 mg/dL

Other:

Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004129

Locations

United States, New York
Center for Molecular Medicine	Recruiting
Garden City, New York, United States, 11530
Contact: Stanley E. Order, MD, ScD, FACR 516-222-5190

Sponsors and Collaborators

Center for Molecular Medicine

Investigators

Study Chair:

Stanley E. Order, MD, ScD, FACR

Center for Molecular Medicine

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

Study ID Numbers:	CDR0000067357, CMM-2, NCI-V99-1575
Study First Received:	December 10, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004129 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent adult brain tumor
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Central Nervous System Neoplasms
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Glioma
Glioblastoma Multiforme
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Astrocytoma
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009