NCT00045617|TerminatedPhase 2DMC

Study Stopped

Closed due to lack of drug availability.

S0122: Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Limited-Stage Small Cell Lung Cancer

A Phase II Trial of Patients With Limited Stage Small Cell Lung Cancer Treated With Thoracic Radiation Therapy and Chemotherapy With Cisplatin/Etoposide Followed by Cisplatin/Etoposide and Anti-Idiotype Monoclonal Antibody Vaccines

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000256922S0122U10CA032102

Study Type

interventional

Target

Locations

2 countries

Sites

100

Timeline

RegisteredJan 2003

StartedJan 2003

CompletionMay 2003

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. Vaccines may make the body build an immune response to kill tumor cells. Combining chemotherapy and radiation therapy with vaccine therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with vaccine therapy in treating patients who have limited-stage small cell lung cancer.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline

Completed

Started Jan 2003

Shorter than P25 for phase_2 lung-cancer

Geographic Reach

2 countries

100 active sites

Status

terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

4 months study duration

First Submitted

Initial submission to the registry

September 6, 2002

Completed

4 months until next milestone

Study Start

First participant enrolled

January 1, 2003

Completed

26 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed

Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

4 months

First QC Date

September 6, 2002

Last Update Submit

June 11, 2012

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

overall survival
time from date of registration to date of death
up to 5 years

Secondary Outcomes (3)

immune response
at Week 10
toxicity assessment
22 weeks
response
25 weeks

Study Arms (1)

cisplatin and etoposide followed by vaccine

EXPERIMENTAL

standard chemotherapy with cisplatin and etoposide followed by cisplans and etoposide with an anti-idiotype monoclonal antibody vaccine

Biological: monoclonal antibody 11D10 anti-idiotype vaccineBiological: monoclonal antibody GD2 anti-idiotype vaccineDrug: cisplatinDrug: etoposideRadiation: radiation therapy