Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

brachytherapy

phosphorus P32

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Molecular MedicineRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004129

First Posted

December 10, 1999

Last Updated

September 16, 2013

Sponsor

Center for Molecular Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00004129

Brief Title

Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Unknown status

Study Start Date

September 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Center for Molecular Medicine

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Radiation

Intervention Name(s)

brachytherapy

Intervention Type

Radiation

Intervention Name(s)

phosphorus P32

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stanley E. Order, MD, ScD, FACR

Organizational Affiliation

Center for Molecular Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

Center for Molecular Medicine

City

Garden City

State/Province

New York

ZIP/Postal Code

11530

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stanley E. Order, MD, ScD, FACR

Phone

516-222-5190

Brain and Central Nervous System Tumors

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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