Irinotecan and Thalidomide in Treating Patients With Advanced Solid Tumors

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