NCT00003263

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy, radiation therapy, and interferon alfa may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of cisplatin plus interferon alfa followed by surgery and interferon alfa plus radiation therapy in treating patients with malignant pleural mesothelioma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 1996

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

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

August 1, 1996

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1999

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2000

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

September 13, 2004

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

3.3 years

First QC Date

November 1, 1999

Last Update Submit

April 16, 2013

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesothelioma

Interventions

recombinant interferon alfaBIOLOGICAL

vaccine

cisplatinDRUG
surgical procedurePROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven ipsilateral malignant pleural mesothelioma * No contralateral thoracic or intra-abdominal involvement * No distant metastases PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0 or 1 * Life expectancy: Not specified * Hematopoietic: * Absolute neutrophil count greater than 2,000/mm3 * Platelet count greater than 100,000/mm3 * No symptomatic anemia requiring transfusion * Hepatic: * Bilirubin less than 2.0 mg/dL * No autoimmune hepatitis * No history of decompensated liver disease; e.g. esophageal varices * Ascites * Albumin at least 2.5 mg/dL * Increasing prothrombin time of at least 2.0 * Renal: Creatinine no greater than 1.5 mg/dL * Cardiovascular: * No symptomatic or debilitating cardiovascular disease, * No concurrent thrombophlebitic or embolic disorders * Pulmonary: * No symptomatic or debilitating pulmonary disease, * Pretreatment diffusion capacity greater than 30% of predicted normal * Projected post-treatment FEV1 at least 1.0 L * Other: * No prior malignancy within 3 years, except nonmelanomatous skin cancer * Carcinoma in situ of the cervix * Ductal carcinoma in situ of the breast * Not pregnant * Fertile patients must use effective contraception * No history of hypersensitivity to interferon or any component of the injection * No uncontrolled diabetes (blood sugars consistently at least 300 mg/dL) * No insulin dependent diabetes mellitus with history of ketoacidosis within 1 year * No psychosis * No uncontrolled thyroid abnormalities * No active infection requiring intravenous antibiotics PRIOR CONCURRENT THERAPY: * Biologic therapy: No prior biologic therapy * Chemotherapy: No prior chemotherapy * Endocrine therapy: Not specified * Radiotherapy: No prior radiotherapy * Surgery: * No prior debulking surgery * No prior chest tube drainage with sclerosis if tumor resectable * Prior thoracentesis allowed

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

Sponsors & Collaborators

Study Sites (3)

Office of S. Terry Kraus

Marrero, Louisiana, 70072, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Interferon-alphaCisplatinSurgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • Corey J. Langer, MD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 13, 2004

Study Start

August 1, 1996

Primary Completion

December 1, 1999

Study Completion

November 1, 2000

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

US(3)