Benzoylphenylurea in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Intervention: benzoylphenylurea
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of benzoylphenylurea in treating patients
      who have advanced solid tumors.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed malignancy

               -  Metastatic or unresectable

               -  No effective standard curative or palliative measures exist

          -  No known CNS or brain metastasis

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-1

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Bilirubin normal

          -  SGOT/SGPT normal

        Renal:

          -  Creatinine normal

          -  Creatinine clearance at least 60 mL/min

        Cardiovascular:

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  No uncontrolled ventricular arrhythmia

          -  No myocardial infarction within the past 3 months

          -  No superior vena cava syndrome

        Neurologic:

          -  No grade 1 or greater peripheral neuropathy

          -  No uncontrolled major seizure disorder

          -  No spinal cord compression

        Other:

          -  No active serious infection requiring IV antibiotics

          -  No concurrent uncontrolled illness

          -  No concurrent unstable or serious medical condition

          -  No chronic diarrhea or malabsorption

          -  No history of allergic reactions to compounds similar in chemical or biological
             composition to benzoylphenylurea

          -  No psychiatric illness or social situation that would preclude study compliance

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No concurrent immunotherapy

          -  No concurrent growth factors during first 2 courses of study

          -  Concurrent epoetin alfa allowed

        Chemotherapy:

          -  At least 28 days since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  No concurrent hormonal therapy

        Radiotherapy:

          -  At least 28 days since prior large-field radiotherapy

          -  Prior palliative radiotherapy for painful bone metastases allowed

          -  No concurrent radiotherapy, including palliative or whole-brain radiotherapy for CNS
             disease

        Surgery:

          -  At least 28 days since prior major surgery

        Other:

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational or commercial agents or therapies for the
             malignancy

          -  No other concurrent investigational agents

          -  Concurrent bisphosphonates allowed if bone metastases are not only site of measurable
             or evaluable disease