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 )

First Received: September 9, 2005 Last Updated: January 10, 2008 History of Changes

Sponsor:	USC/Norris Comprehensive Cancer Center
Information provided by:	USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00183950

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Noscapine Noscapine hydrochloride

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

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

Additional relevant MeSH terms:

Noscapine
Respiratory System Agents
Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Pharmacologic Actions
Leukemia
Lymphatic Diseases

Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Therapeutic Uses
Antitussive Agents
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Central Nervous System Agents
Lymphoma

ClinicalTrials.gov processed this record on February 08, 2010