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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00610883
First received: December 26, 2007
Last updated: December 21, 2015
Last verified: December 2015
  Purpose

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

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Complete Remission [ Time Frame: 330 Days ] [ Designated as safety issue: No ]
    The number of patients who achieved a complete remission as a result of treatment


Enrollment: 17
Study Start Date: May 1990
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - LSA4 Drug: LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU
LSA4 intervention includes three phases: induction, consolidation and maintenance

  Eligibility

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610883

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Tanya Trippett, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00610883     History of Changes
Other Study ID Numbers: 90-042 
Study First Received: December 26, 2007
Results First Received: December 21, 2015
Last Updated: December 21, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
Asparaginase
Daunorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016