The Online Asbestos, Asbestos Cancer, & Mesothelioma Authority

Clinical Trials

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: Â	80
Study Start Date: Â	October 2003
Estimated Primary Completion Date: Â	June 2006 (Final data collection date for primary outcome measure)

Detailed Description:

DISEASE CHARACTERISTICS:

• Histologically confirmed malignancy, including the following types:
  • Hematologic malignancy, including any of the following: (Accrual for patients with hematologic malignancies temporarily closed as of 11/30/04)
    • Mantle cell lymphoma
      • Morphologically confirmed disease
      • CD20 and CD5 positive
    • Any other refractory lymphoma
    • Chronic lymphocytic leukemia
      • Rai stage III or IV and meeting at least 1 of the following criteria for active disease:
        • Weight loss > 10% in the last 6 months
        • Fatigue
        • Fever or night sweats with no evidence of infection
        • Progressive anemia or thrombocytopenia
        • Progressive lymphocytosis with a lymphocyte doubling time of < 6 months
        • Marked hypogammaglobulinemia or paraproteinemia
        • Progressive splenomegaly and/or lymphadenopathy
    • Multiple myeloma
      • Disease confirmed by bone marrow aspirate and/or biopsy
      • Relapsed or refractory disease after the most recent treatment regimen
      • Quantifiable monoclonal immunoglobulin in serum and/or urine
  • Solid tumor, including but not limited to any of the following:
    • Breast cancer
      • Histologically or cytologically confirmed stage IV invasive disease
      • HER-2 positivity not required for study enrollment
        • Tumor overexpressing HER-2 should be confirmed by immunohistochemistry OR fluorescence in situ hybridization
    • Small cell lung cancer
      • Extensive stage or limited stage disease in relapse
      • Extrapulmonary small cell carcinoma allowed
    • Squamous cell carcinoma of the head and neck
      • Metastatic, recurrent, or refractory disease
    • Renal cell carcinoma
    • Mesothelioma
      • Pleural or peritoneal disease of epithelial, sarcomatoid, or mixed subtype
    • Melanoma
    • Kaposi's sarcoma
• Metastatic or unresectable disease for which standard therapy does not exist or is no longer effective
• Measurable or nonmeasurable disease (solid tumor patients)
  • Measurable disease defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or 10 mm by spiral CT scan
  • Nonmeasurable disease includes any of the following:
    • All other lesions, including lesions < 20 mm by conventional techniques or 10 mm by spiral CT scan
    • Bone lesions
    • Cytologically positive pleural or peritoneal disease
    • Elevated tumor marker (e.g., CEA, CA 125, CA 19-9, or other tumor marker)
    • Multinodular or confluent nonmeasurable pulmonary, hepatic, adrenal, intra-abdominal, or skin metastases
• Previously treated with at least 1 chemotherapy regimen*
  • Prior therapy may have included combined modality treatment (e.g., full-dose chemotherapy and radiotherapy with radiosensitizing chemotherapy)
  • Prior therapy with flavopiridol allowed provided the patient was enrolled in a flavopiridol clinical trial employing a different schedule NOTE: *Except in cases where chemotherapy is not known to be effective (e.g., renal cell carcinoma, chondrosarcoma, or gastrointestinal stromal tumor)
• No active CNS metastases
  • History of CNS metastases allowed provided all of the following criteria are met:
    • Previously treated and stable and asymptomatic for at least 4 weeks since the completion of treatment
    • Image documentation required
    • Off steroids or on a stable dose of steroids for at least 1 week
• Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1 OR
• Karnofsky 70-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3*
• Platelet count > 75,000/mm^3 (50,000 for hematologic malignancies)* (Accrual for patients with hematologic malignancies temporarily closed as of 11/30/04) NOTE: *Unless abnormality is caused by tumor burden and not cumulative prior chemotherapy

Hepatic

• Bilirubin normal
• AST/ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

Renal

• Creatinine ≤ 2.0 mg/dL OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No myocardial infarction within the past 6 months
• No unstable angina within the past 6 months
• No transient ischemic attack or cerebrovascular accident within the past 6 months
• No history of arterial vascular events
• No new cardiac arrhythmias likely to be related to cardiac ischemia within the past 6 months
• No symptomatic congestive heart failure

Pulmonary

• No history of pulmonary embolism within the past 6 months

Gastrointestinal

• No chronic diarrheal disease within the past 6 months
• No severe malnutrition
• No intractable emesis

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective hormonal or barrier contraception
• No ongoing or active infection
• No other concurrent uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior biologic therapy (e.g., monoclonal antibody therapy, immunologic therapies, epidermal growth factor receptor inhibitors, angiogenesis inhibitors, or other investigational agents) allowed
• At least 4 weeks since prior monoclonal antibody therapy

Chemotherapy

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy
• No prior radiotherapy to 50% or more of bone marrow

Surgery

• Not specified

Other

• Recovered from all prior therapy
• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients

epithelial mesothelioma   recurrent malignant mesothelioma   sarcomatous mesothelioma   stage IV mantle cell lymphoma   recurrent mantle cell lymphoma   recurrent breast cancer   stage IV breast cancer   extensive stage small cell lung cancer   limited stage small cell lung cancer   recurrent squamous cell carcinoma of the lip and oral cavity Â

stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary salivary gland squamous cell carcinoma stage IV salivary gland cancer recurrent salivary gland cancer recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx

Thoracic Neoplasms Sezary syndrome Hodgkin lymphoma, adult Malignant mesenchymal tumor Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Neoplasms, Connective and Soft Tissue Kaposi sarcoma

Hemorrhagic Disorders Lung Neoplasms Metastatic squamous neck cancer with occult primary Lymphoma, Large-Cell, Anaplastic Neuroepithelioma Laryngeal carcinoma Kidney Diseases Hematologic Diseases Blood Coagulation Disorders Breast Neoplasms

Mesothelioma Skin and Connective Tissue Diseases Hemic and Lymphatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Neoplasms, Mesothelial Physiological Effects of Drugs Neoplasms, Nerve Tissue Ileal Diseases

Protein Kinase Inhibitors Female Urogenital Diseases and Pregnancy Complications Neoplasms by Site Respiratory Tract Diseases Jejunal Diseases Therapeutic Uses Cardiovascular Diseases Nevi and Melanomas Growth Inhibitors Respiratory Tract Neoplasms