A Phase II Study of Rebeccamycin Analog in Renal Cell Cancer
becatecarin
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: June 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Barbara Ann Karmanos Cancer Institute
Detroit, United StatesOpen Barbara Ann Karmanos Cancer Institute in Google Maps