Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00025415
• Date of registration: 11/10/2001
• Prospective Registration: No
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver Dysfunction
• Scientific title: A Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Levels of Liver Dysfunction
• Date of first enrolment: August 2001
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00025415
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Ramesh Ramanathan
• Affiliation: University of Pittsburgh

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically or cytologically confirmed surgically incurable solid tumor
orhematologic malignancy for which no standard or palliative therapy exists oris no
longer effective

- All tumor types are eligible, including:

- Chronic myelogenous leukemia or other Philadelphia chromosome-positive
leukemia OR

- Gastrointestinal stromal tumors

- Patients with gliomas that require corticosteroids or anticonvulsants must beon a
stable dose and seizure-free for 1 month

- No unstable or untreated (non-irradiated) brain metastases

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- More than 3 months

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- No active hemolysis

- See Surgery

- No evidence of biliary sepsis

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Able to swallow pills

- No other uncontrolled concurrent illness that would preclude study participation

- No ongoing or active infection

- No uncontrolled diarrhea

- No psychiatric illness or social situation that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 6 months
after study completion

- At least 24 hours since prior colony-stimulating factors

- No concurrent colony-stimulating factors

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered

- See Disease Characteristics

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy and recovered

- See Disease Characteristics

- At least 10 days since prior placement of shunt for treatment of biliary obstruction

- At least 14 days since prior major surgery

- No prior solid organ transplantation

- No other concurrent investigational agents

- No concurrent therapeutic doses of warfarin for anticoagulation

- No other concurrent investigational or commercial agents or therapies for treatment
of this disease

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent acetaminophen of more than 4,000 mg/day



Age minimum: 15 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Undifferentiated Leukemia

Anaplastic Large Cell Lymphoma

Childhood Myelodysplastic Syndromes

Chronic Eosinophilic Leukemia

Chronic Myelogenous Leukemia, BCR-ABL1 Positive

de Novo Myelodysplastic Syndromes

Extramedullary Plasmacytoma

Meningeal Chronic Myelogenous Leukemia

Prolymphocytic Leukemia

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Recurrent Adult Burkitt Lymphoma

Recurrent Adult Hodgkin Lymphoma

Recurrent Adult Acute Myeloid Leukemia

Recurrent Marginal Zone Lymphoma

Recurrent Mantle Cell Lymphoma

Refractory Multiple Myeloma

Recurrent Mycosis Fungoides/Sezary Syndrome

Refractory Hairy Cell Leukemia

Accelerated Phase Chronic Myelogenous Leukemia

Nodal Marginal Zone B-cell Lymphoma

Recurrent Adult T-cell Leukemia/Lymphoma

Splenic Marginal Zone Lymphoma

Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma

Essential Thrombocythemia

Intraocular Lymphoma

AIDS-related Peripheral/Systemic Lymphoma

AIDS-related Primary CNS Lymphoma

Monoclonal Gammopathy of Undetermined Significance

Angioimmunoblastic T-cell Lymphoma

Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative

Chronic Neutrophilic Leukemia

Chronic Phase Chronic Myelogenous Leukemia

Secondary Acute Myeloid Leukemia

Secondary Myelodysplastic Syndromes

T-cell Large Granular Lymphocyte Leukemia

Waldenström Macroglobulinemia

Isolated Plasmacytoma of Bone

Polycythemia Vera

Blastic Phase Chronic Myelogenous Leukemia

Chronic Myelomonocytic Leukemia

Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable

Gastrointestinal Stromal Tumor

Previously Treated Myelodysplastic Syndromes

Relapsing Chronic Myelogenous Leukemia

Stage IV Adult Diffuse Large Cell Lymphoma

Progressive Hairy Cell Leukemia, Initial Treatment

Stage IV Adult Diffuse Mixed Cell Lymphoma

Stage IV Grade 1 Follicular Lymphoma

Stage IV Adult Lymphoblastic Lymphoma

Stage IV Adult T-cell Leukemia/Lymphoma

Primary Systemic Amyloidosis

Recurrent Adult Diffuse Mixed Cell Lymphoma

Primary Central Nervous System Non-Hodgkin Lymphoma

Stage IV Mantle Cell Lymphoma

Unspecified Adult Solid Tumor, Protocol Specific

Recurrent Adult Lymphoblastic Lymphoma

Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma

Stage IV Mycosis Fungoides/Sezary Syndrome

Recurrent Grade 1 Follicular Lymphoma

Small Intestine Lymphoma

Recurrent Adult Acute Lymphoblastic Leukemia

Recurrent Adult Diffuse Large Cell Lymphoma

Recurrent Grade 2 Follicular Lymphoma

Recurrent Grade 3 Follicular Lymphoma

Recurrent Adult Immunoblastic Large Cell Lymphoma

Stage IV Grade 3 Follicular Lymphoma

Stage IV Small Lymphocytic Lymphoma

Stage IV Adult Burkitt Lymphoma

Stage IV Adult Diffuse Small Cleaved Cell Lymphoma

Untreated Adult Acute Lymphoblastic Leukemia

Untreated Hairy Cell Leukemia

Recurrent Small Lymphocytic Lymphoma

Stage IV Chronic Lymphocytic Leukemia

Stage IV Grade 2 Follicular Lymphoma

Stage IV Marginal Zone Lymphoma

Primary Myelofibrosis

Recurrent Adult Diffuse Small Cleaved Cell Lymphoma

Stage IV Adult Hodgkin Lymphoma

Stage IV Adult Immunoblastic Large Cell Lymphoma

Refractory Chronic Lymphocytic Leukemia

Untreated Adult Acute Myeloid Leukemia

Intervention(s)

Drug: imatinib mesylate

Other: pharmacological study

Primary Outcome(s)

MTD defined based on the toxicities observed during the first cycle of treatment [Time Frame: 4 weeks]

Toxicity evaluation graded according to the NCI common toxicity criteria and relationship to the study drug [Time Frame: Up to 4 years]

Secondary Outcome(s)

Child-Pugh Classification [Time Frame: Baseline]

Responses [Time Frame: Up to 4 years]

Pharmacokinetic data [Time Frame: Day 1, 2, 3, 4, 15, 16]

Secondary ID(s)

CDR0000068959

NCI-2012-02418

01-028

U01CA062505

U01CA062502

U01CA099168

U01CA062487

U01CA062491

Source(s) of Monetary Support

Please refer to primary and secondary sponsors