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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00086840 |
RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory chronic lymphocytic leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: temsirolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia |
Study Start Date: | July 2004 |
OBJECTIVES:
OUTLINE: Patients are stratified according to disease (relapsed or refractory chronic lymphocytic leukemia [CLL] vs transformed CLL).
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.
PROJECTED ACCRUAL: A total of 25-60 patients (12-36 patients with relapsed or refractory chronic lymphocytic leukemia [CLL] and 13-24 patients with transformed CLL) will be accrued for this study within 40 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia (CLL)
Relapsed, refractory, or transformed disease
Transformed CLL (Richters transformation), must meet both of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4095 |
Study Chair: | Francis J. Giles, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000371619, MDA-2003-0886, NCI-6177 |
Study First Received: | July 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00086840 |
Health Authority: | United States: Federal Government |
refractory chronic lymphocytic leukemia recurrent adult diffuse large cell lymphoma recurrent adult Hodgkin lymphoma |
Chronic lymphocytic leukemia Leukemia, Lymphoid Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hodgkin's disease Hodgkin lymphoma, adult Leukemia, B-cell, chronic Recurrence |
Lymphoma, large-cell Leukemia Lymphatic Diseases Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma Hodgkin Disease |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |