Clinical trial NCT00074308 (phase 1/phase 2, status: completed)
Conditions: recurrent melanoma, stage iii melanoma, stage iv melanoma, unspecified adult solid tumor, protocol specific
ICD codes: G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: imatinib mesylate
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of 1 of the following:

               -  Metastatic or unresectable malignancy for which standard curative or palliative
                  measures do not exist or are no longer effective (phase I) (phase I study closed
                  to accrual as of 8/23/04)

               -  Melanoma (phase I and II)

          -  Measurable disease (phase II)

          -  No history or clinical evidence of CNS disease, including primary brain tumor or brain
             metastases

          -  Performance status - ECOG 0-1

          -  More than 3 months

          -  WBC at least 3,000/mm^3

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

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

          -  No history of bleeding diathesis or coagulopathy

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST and ALT no greater than 2.5 times ULN

          -  INR no greater than 1.5

          -  APTT normal

          -  Creatinine no greater than 2.0 times ULN

          -  Creatinine clearance at least 40 mL/min

          -  No proteinuria

          -  Urinary protein less than 500 mg/24 hours

          -  No history of stroke

          -  No uncontrolled hypertension within the past 6 months

               -  Blood pressure less than 150/100 mm Hg on a stable antihypertensive regimen

          -  None of the following within the past 6 months:

               -  Myocardial infarction

               -  Unstable angina

               -  New York Heart Association class II-IV congestive heart failure

               -  Serious cardiac arrhythmia requiring medication

               -  Grade II or greater peripheral vascular disease

               -  Transient ischemic attack

               -  Cerebrovascular accident

               -  Other arterial thromboembolic event

               -  Other clinically significant cardiovascular disease

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception during and for at least 3
             months after study participation

          -  No seizures not controlled with standard medical therapy

          -  No prior allergic reactions attributed to Chinese hamster ovary cell products, other
             recombinant human antibodies, or compounds of similar chemical or biological
             composition to imatinib mesylate

          -  No serious, nonhealing wound, ulcer, or bone fracture

          -  No ongoing or active infection requiring parenteral antibiotics

          -  No significant traumatic injury within the past 28 days

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

          -  No other concurrent uncontrolled illness

          -  More than 4 weeks since prior immunotherapy

          -  More than 8 weeks since prior monoclonal antibody therapy

          -  No concurrent prophylactic granulocyte or platelet colony-stimulating factors

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

          -  No more than 1 prior cytotoxic chemotherapy regimen for advanced disease (phase II)

          -  More than 4 weeks since prior radiotherapy

          -  More than 28 days since prior major surgical procedure or open biopsy

          -  Recovered from prior therapy

          -  No concurrent chronic daily aspirin (greater than 325 mg/day) or nonsteroidal
             anti-inflammatory drugs known to inhibit platelet function

          -  No recent or concurrent full-dose anticoagulants (except as required to maintain
             patency of preexisting permanent indwelling IV catheters) or thrombolytic agent

          -  No concurrent grapefruit juice

          -  No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin,
             carbamazepine, or phenobarbital)

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational or commercial agents or therapies directed at the
             malignancy

          -  No other concurrent investigational agents