NCT00054002

Brief Summary

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Combining photodynamic therapy with surgery may be an effective treatment for malignant mesothelioma. PURPOSE: Phase II trial to study the effectiveness of combining photodynamic therapy with surgery in treating patients who have malignant mesothelioma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 1, 2011

Status Verified

February 1, 2011

Enrollment Period

7.3 years

First QC Date

February 5, 2003

Last Update Submit

February 25, 2011

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesotheliomarecurrent malignant mesotheliomaepithelial mesotheliomasarcomatous mesothelioma

Outcome Measures

Primary Outcomes (3)

  • Feasibility

    1 month, every 4 months for 2 years, and then every 6 months for 3 years

  • Comparison of results from this regimen to historical controls

    At completion of study

  • Toxic effects

    1 month, every 4 months for 2 years, and then every 6 months for 3 years

Interventions

adjuvant therapyPROCEDURE

Lung surgery

conventional surgeryPROCEDURE

Lung surgery

porfimer sodiumDRUG

iv

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant mesothelioma, including the following cell types: * Mixed mesothelial * Sarcomatous * Stage I or II disease using the Butchart system as determined by CT scan or MRI * Disease confined to 1 hemithorax * No tumor involvement of esophagus or heart as evidenced by CT scan * Pericardial or diaphragmatic involvement allowed if disease is limited to the ipsilateral chest * N2 disease allowed if no contralateral pleural involvement * No adenocarcinoma or nonmesothelioma sarcoma of the chest wall PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC greater than 4,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.5 g/dL (transfusion allowed) Hepatic * Bilirubin less than 3.0 mg/dL * Alkaline phosphatase less than 2 times upper limit of normal (ULN) * SGOT less than 2 times ULN Renal * Creatinine less than 3.0 mg/dL Cardiovascular * No myocardial infarction within the past 6 months Pulmonary * Arterial partial pressure of carbon dioxide (pCO\_2) less than 50 torr at rest * Predicted postoperative FEV\_1 at least 800 mL with maximum oxygen consumption/kg at least 15 mL/min * Predicted postoperative total lung capacity at least 40% of hemoglobin and alveolar ventilation Other * Not pregnant * No other concurrent malignancy except nonmelanoma skin cancer * No contraindication to general anesthetic * No history of porphyria * No indicated sensitivity to porfimer sodium PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 30 days since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the chest * No prior radiotherapy for mesothelioma Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Mesothelioma, MalignantSolitary Fibrous Tumor, Pleural

Interventions

Chemotherapy, AdjuvantDihematoporphyrin Ether

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract DiseasesSolitary Fibrous TumorsNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyHematoporphyrin DerivativeHematoporphyrinsPorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPigments, BiologicalBiological Factors

Study Officials

  • Todd L. Demmy, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

March 1, 1999

Primary Completion

June 1, 2006

Study Completion

December 1, 2010

Last Updated

March 1, 2011

Record last verified: 2011-02

Locations

US(1)