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

Sponsor

University of Southern California (Other)

Overall Status

Terminated

CT.gov ID

NCT00183950

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

12 participants

Allocation:

N/A

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 :

Mar 1, 2000

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.