Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004129
First received: December 10, 1999
Last updated: September 16, 2013
Last verified: April 2008
  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 1

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00004129     History of Changes
Other Study ID Numbers: CDR0000067357, CMM-2, NCI-V99-1575
Study First Received: December 10, 1999
Last Updated: September 16, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Glioblastoma
Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on October 22, 2014