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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

0C-99-16

NCT ID:

NCT00183950

Start Date:

March 2000

Completion Date:

December 2006

Related Keywords:

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

Name

Location

USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804