Clinical trial NCT00062127 (phase 1, status: completed)
Conditions: unspecified adult solid tumor, protocol specific
ICD codes: H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: irinotecan hydrochloride, thalidomide
SMILES: CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12, CC(C)NCC(O)COC1=CC=CC2=C1C=CC=C2
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed malignant solid tumor

               -  Metastatic or unresectable

               -  Standard curative or palliative therapy is no longer effective or does not exist

          -  Measurable or assessable disease

          -  No uncontrolled brain metastases

               -  Patients with brain metastases are eligible provided the following are true:

                    -  Stable neurologic status

                    -  At least 4 weeks since prior steroids or anticonvulsants

                    -  No neurologic dysfunction that would confound evaluation

          -  Performance status - Karnofsky 70-100%

          -  More than 12 weeks

          -  WBC at least 3,000/mm^3

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

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

          -  Bilirubin normal

          -  AST and ALT no greater than 2.5 times upper limit of normal

          -  Creatinine normal

          -  Creatinine clearance at least 60 mL/min

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No history of inflammatory bowel disease requiring therapy

          -  No chronic diarrhea syndromes

          -  No paralytic ileus

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile female patients must use 2 forms of effective contraception, including 1
             highly effective method, for at least 4 weeks before, during, and for 4 weeks after
             study participation

          -  Male patients must use effective barrier contraception during and for 4 weeks after
             study participation

          -  No prior allergic reaction attributed to compounds of similar chemical or biological
             composition to study drugs

          -  No uncontrolled seizure disorder

          -  No other concurrent uncontrolled illness that would preclude study participation

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

          -  No ongoing or active infection

          -  No significant traumatic injury within the past 28 days

          -  No serious, nonhealing wounds or ulcers

          -  No bone fractures

          -  No preexisting peripheral neuropathy grade 2 or greater

          -  At least 4 weeks since prior biologic therapy

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

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy

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

          -  At least 4 weeks since prior investigational therapy

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational or commercial agents or therapies for the
             malignancy