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

This study has been terminated.
(No funding)
Sponsor:
Information provided by:
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00183950
First received: September 9, 2005
Last updated: January 10, 2008
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
 Drug: Noscapine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USC/Norris Comprehensive Cancer Center:

Estimated Enrollment: 44
Study Start Date: March 2000
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00183950

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

No publications provided

ClinicalTrials.gov Identifier: NCT00183950     History of Changes
Other Study ID Numbers: 0C-99-16
Study First Received: September 9, 2005
Last Updated: January 10, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013