BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Enzyme Inhibitors

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma (RCC)

• Recurrent AND unresectable disease OR

• Unresectable disease OR

• Metastatic disease

• At least 1 bidimensionally measurable lesion by CT scan or MRI

• No metastatic brain or meningeal tumors unless more than 3 months since prior surgery and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4 weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9 g/dL

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present)

• No chronic hepatitis B or C

Renal:

• Creatinine no greater than 1.5 mg/dL

• Calcium normal

Cardiovascular:

• No clinically evident congestive heart failure

• No serious cardiac arrhythmias

• No symptoms of coronary heart disease

• No symptoms of ischemia

Other:

• HIV negative

• No active infections requiring systemic antibacterial, antifungal, or antiviral therapy

• No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1)

• No substance abuse

• No medical, psychological, or social conditions that would preclude study

• No known or suspected allergy to study drug or any other study agents

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior anticancer vaccine therapy

• No prior bone marrow transplantation or stem cell rescue

• More than 4 weeks since prior thalidomide and bevacizumab

• At least 4 weeks since prior interleukin-2 and interferon

• No more than 2 prior regimens

• No concurrent bone marrow transplantation or stem cell rescue

Chemotherapy:

• No prior cytotoxic chemotherapy

• No concurrent cytotoxic chemotherapy

Endocrine therapy:

• See Disease Characteristics

• No prior hormonal therapy for RCC

• No concurrent hormonal therapy for RCC

Radiotherapy:

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy

• No prior radiotherapy to indicator lesion unless progression is documented

Surgery:

• See Disease Characteristics

• More than 3 weeks since prior major surgery

Other:

• At least 4 weeks since prior investigational anticancer drugs

• No other concurrent investigational anticancer drugs