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Study of Noscapine for Patients With Low Grade Non Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Refractory to Chemotherapy

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ClinicalTrials.gov Identifier: NCT00183950
Recruitment Status : Terminated (No funding)
First Posted : September 16, 2005
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is for patients with non-hodgkin's lymphoma or chronic lymphocytic leukemia, which has failed to shrink or has returned after previous treatment with chemotherapy. The purpose of this study is to find out whether patients with these types of cancer will have their tumor shrunk after treatment with a drug called Noscapine. The second purpose is to see what are the side effects of this drug. This drug is being used as an over-the-counter cough suppressor in Europe and Japan, but has also shown to be effective against cancer.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Drug: Noscapine Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Noscapine for Patients With Low Grade Non Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Refractory to Chemotherapy
Study Start Date : March 2000
Primary Completion Date : December 2006
Study Completion Date : December 2006


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with low grade NHL (follicular lymphoma, small cell lymphocytic lymphoma, marginal cell lymphoma, monocytoid B-cell lymphoma, MALT lymphoma, plasmacytoid lymphocytic lymphoma) or chronic lymphocytic leukemia who have demonstrated chemotherapy resistance (have not achieved CR,CRu, PR)or who have relapsed at any time following a response (CR, CRu, PR) after at least one therapy regimen, including chemotherapy, Rituximab, or high dose chemotherapy with stem cell rescue.
  • Karnofsky performance status 60 % or greater.
  • Creatinine less or equal to 2.0 mg/dl, bilirubin less or equal to 2.0 mg/dl, SGPT/SGOT less or equal to 4 x upper normal range

Exclusion Criteria:

  • Patients with unconfirmed complete response(CRu)after last treatment and who currently remain in CRu.
  • Pregnant or lactating women.
  • Disease-specific treatment less than 1 month prior to starting this study.
  • CNS disease.
  • HIV-positive patients.
  • Other cancer, except basal cell or squamous cell cancer of the skin or carcinoma in-situ of cervix.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183950


Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
More Information

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00183950     History of Changes
Other Study ID Numbers: 0C-99-16
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Noscapine
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antitussive Agents
Respiratory System Agents