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