High Light and Low Light Dose PDT in Glioma | NCT00118222

Studies
High Light and Low Light Dose PDT in Glioma

NCT00118222

Sponsor

Case Comprehensive Cancer Center

Status

Completed

Last Update Posted

Jun 11, 2010Estimated

Enrollment

1Actual

Phase

Phase 3

Conditions

Brain and Central Nervous System Tumors

Interventions

porfimer sodium
adjuvant therapy
conventional surgery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P30CA043703	U.S. NIH Grant/Contract		View source
CASE-4303	Other Identifier	Case Comprehensive Cancer Center
CWRU-00003937
CWRU-4303	Other Identifier	Case Comprehensive Cancer Center

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Jul 8, 2005

First Submission Date that Met QC Criteria

Jul 8, 2005

First Posted Date

Jul 11, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2010

Last Update Posted Date

Jun 11, 2010Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells.

PURPOSE: This randomized clinical trial is studying two different light doses of photodynamic therapy using porfimer sodium to compare how well they work in treating patients who are undergoing surgery for recurrent malignant astrocytoma.

Detailed Description

OBJECTIVES:

Compare survival of patients undergoing surgical resection for recurrent high-grade malignant supratentorial astrocytoma treated with intraoperative high vs low light dose photodynamic therapy using porfimer sodium.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and tumor resection.

Arm I: During surgery, patients receive low light dose photodynamic therapy.
Arm II: During surgery, patients receive high light dose photodynamic therapy. After completion of study treatment, patients are followed at 1 day, 6 weeks, and 3 months and then every 3 months for up to 2 years.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 4-5 years.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low light dose during surgery	Active Comparator	Arm I: During surgery, patients receive low light dose photodynamic therapy.	Drug: porfimer sodium Procedure: adjuvant therapy Procedure: conventional surgery
High light dose during surgery	Active Comparator	Arm II: During surgery, patients receive high light dose photodynamic therapy.	Drug: porfimer sodium Procedure: adjuvant therapy Procedure: conventional surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
porfimer sodium	Drug	All patients receive porfimer sodium IV.	High light dose during surgery Low light dose during surgery

Measure	Description	Time Frame
Time to progression and survival measured		at 4-6 weeks post-operatively and then every 3-4 months thereafter

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed malignant supratentorial astrocytoma, glioblastoma, or mixed oligo-astrocytoma
- Grade 3 or 4 tumor, defined as presence of ≥ 2 of the following features:
  - Nuclear atypia
  - Mitosis
  - Endothelial proliferation
  - Necrosis
Recurrent disease
- Failed prior surgery and radiotherapy
Tumor suitable for radical resection by imaging studies

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

At least 3 months

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use effective contraception
Willing to avoid direct sun-light exposure for 6 weeks after photodynamic therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D016543	Central Nervous System Neoplasms
D005910	Glioma
D001254	Astrocytoma
D001932	Brain Neoplasms
D005909	Glioblastoma
D018316	Gliosarcoma

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009422	Nervous System Diseases

ID	Term
D017323	Dihematoporphyrin Ether
D017024	Chemotherapy, Adjuvant

ID	Term
D017324	Hematoporphyrin Derivative
D006415	Hematoporphyrins
D011166	Porphyrins
D045725	Tetrapyrroles