B-cell Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I Dose-Escalation Study of Flavopiridol (NSC 649890) Administered as a 30 Minute Loading Dose Followed by a 4-Hour Infusion in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Following Cytoreduction With Chemotherapy
Verified date | July 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as alvocidib, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Status | Terminated |
Enrollment | 24 |
Est. completion date | |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of 1 of the following: - B-cell chronic lymphocytic leukemia (CLL) - Small lymphocytic lymphoma (SLL) - Must have received 1-3 prior therapies for CLL - Completed therapy 2-12 months ago - Prior therapy must have led to a partial response or greater - No evidence of progressive disease - ECOG performance status 0-2 - Absolute neutrophil count = 1,000/mm³ - WBC = 5,000/mm³ - Platelet count = 50,000/mm³ - Cytopenia allowed - Creatinine < 2.0 mg/dL - Bilirubin = 1.5 times normal (unless due to Gilbert's disease or hemolysis) - AST = 2 times normal (unless due to hemolysis) - No secondary malignancy or other disease that would limit survival to < 2 years - No history of inflammatory bowel disease unless inactive for > 2 years - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - See Disease Characteristics - No other concurrent chemotherapy - No concurrent radiotherapy - No concurrent dexamethasone or other corticosteroid-based antiemetics - No concurrent chronic corticosteroid therapy - No other concurrent hormonal therapy except for the following: - Steroids for new adrenal failure - Hormones for nondisease-related conditions (e.g., insulin for diabetes) |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity profile of alvocidib administered as a 30 minute loading dose followed by a 4-hour infusion once weekly for 3 consecutive weeks every 5 weeks as consolidation therapy following cytoreduction chemotherapy | Assessed utilizing the NCI Common Terminology Criteria for Adverse Events version 3.0. | Day 1, every 2 courses, at 2 months and then every 3 months for 5 years after completion of study treatment | Yes |
Primary | Dose-limiting toxicity of alvocidib as consolidation chemotherapy after cytoreduction chemotherapy in patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma | The National Cancer Institute Common Toxicity Criteria version 3.0 will be used to characterize toxicity. If no patients experience dose-limiting toxicity, dose escalation will occur. If 1 patient has a dose limiting toxicity, 3 additional patients will be enrolled at that dose. If fewer than 2 of 6 patients experiences dose limiting toxicity, then the next highest dose level will be used for the subsequent cohort of 3 patients. If at any dose level two or more of the six patients experience a dose limiting toxicity, 3 additional patients will be treated at the previous dose level. | Course 1 | Yes |
Secondary | Pharmacokinetics and cellular pharmacodynamics of alvocidib administered in this schedule | Cytokine studies will be examined by standard ELISA assays to determine if increase IL-6 correlates with hypotension, hypoxemia, and tachycardia observed following treatment and to identify the source of production of this cytokine. We will examine interphase cytogenetics, p53 mutational status, p53/ATM functional assay, VH mutational status, and ZAP-70 over-expression. | Baseline and day 1 | No |
Secondary | Complete response (CR) and overall response rate (CR and partial response) of alvocidib in patients with previously-treated CLL | Criteria for response will utilize the Revised National Cancer Institute-sponsored Working Group Guidelines. | Baseline, every 2 courses, at 2 months and then every 3 months for 5 years after completion of study treatment | No |
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