LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma

This study has been completed.

Sponsor:

Information provided by:

Memorial Sloan-Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT00610883

First received: December 26, 2007

Last updated: January 6, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

January 6, 2009

Start Date ^ICMJE

May 1990

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Non-Hodgkin Cancer does not return 3 years after completing treatment [ Time Frame: 330 Days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00610883 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma

Official Title ^ICMJE

LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma

Brief Summary

Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6 months. To aggressively treat this cancer this study uses effective drugs in three parts:

Induction ends on day 19
Consolidation ends on day 38 or 42
Maintenance may include up to 6 cycles

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-Hodgkin's Lymphoma

Intervention ^ICMJE

Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU

LSA4 intervention includes three phases: induction, consolidation and maintenance

Study Arm (s)

Experimental: 1 - LSA4

Intervention: Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Non-Hodgkin's Lymphoma stages III, IV, IVA with
1. T cell lymphomas, any primary site irrespective of LDH level
2. large cell lymphomas, any primary site irrespective of LDH level
3. B cell lymphomas, any primary site with initial LDH of less than 500

Exclusion Criteria:

B cell lymphomas, any primary site with initial LDH of less than 500 and initial CNS or bone involvement

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00610883

Other Study ID Numbers ^ICMJE

90-042

Has Data Monitoring Committee

Not Provided

Responsible Party

Tanya Trippett, Md, Memorial Sloan-Kettering Cancer Center

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Tanya Trippett, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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