Benzoylphenylurea in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)

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