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Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00004129
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Center for Molecular Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Stanley E. Order, MD, ScD, FACR
Principal Investigator Affiliation Center for Molecular Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Center for Molecular Medicine, Garden City, New York

Status

Recruiting

Address

Center for Molecular Medicine

Garden City, New York, 11530

Site Contact

Stanley E. Order, MD, ScD, FACR

516-222-5190

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