Expired Study
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Detroit, Michigan 48201


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of rebeccamycin analog in treating patients who have advanced kidney cancer.


Study summary:

OBJECTIVES: - Determine the response rate of patients with advanced renal cell carcinoma when treated with rebeccamycin analogue. - Assess the quantitative and qualitative toxicities associated with this drug in this patient population. OUTLINE: Patients receive rebeccamycin analogue IV over 30-60 minutes daily for 5 days. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 23-44 patients will be accrued for this study within 9-18 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed locally advanced unresectable, locally recurrent, or metastatic renal cell carcinoma not eligible for a higher priority trial - Measurable disease - Longest diameter at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan - No nonmeasurable disease only including: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses not confirmed and followed by imaging techniques - Cystic lesions - No known brain metastases - History of brain metastases that have been resected and/or irradiated with subsequent normal brain CT scan allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - Greater than 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of any site - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue - No other concurrent uncontrolled illness (e.g., ongoing or active infection) - No concurrent psychiatric illness or social situation that would preclude study compliance - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior biologic therapy allowed - Recovered from toxic effects Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics Other: - No other concurrent investigational or commercial agents or therapies for renal cell cancer


NCT ID:

NCT00005027


Primary Contact:

Study Chair
Ulka N. Vaishampayan, MD
Barbara Ann Karmanos Cancer Institute


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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