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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00183950
• Other study ID #: 0C-99-16
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: May 20, 2014
• Start date: March 2000
• Est. completion date: December 2006

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Noscapine

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States,