OBJECTIVES:

• Determine whether thalidomide alters the pharmacokinetics of irinotecan in patients with advanced solid tumors.
• Determine whether irinotecan alters the pharmacokinetics of thalidomide in these patients.
• Determine the toxicity of this regimen in these patients.
• Determine the observed antitumor response in patients treated with this regimen.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive irinotecan IV over 90 minutes on days 1 and 22 and oral thalidomide once daily on days 15-28.
• Arm II: Patients receive irinotecan as in arm I and oral thalidomide once daily on days -6 to 7.

All patients undergo disease re-evaluation at 6 weeks. Patients with stable or responsive disease may receive additional courses comprising irinotecan IV on day 1 and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

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

Renal

• Creatinine normal OR
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Gastrointestinal

• No history of inflammatory bowel disease requiring therapy
• No chronic diarrhea syndromes
• No paralytic ileus

Other

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 4 weeks since prior biologic therapy

Chemotherapy

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

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• At least 4 weeks since prior radiotherapy

Surgery

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

Other

• 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