Rebeccamycin Analog in Treating Patients With Advanced Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

A Phase II Study of Rebeccamycin Analog in Renal Cell Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005027
• Other study ID #: CDR0000067548
• Secondary ID: U01CA062487P30CA
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: April 3, 2013
• Start date: June 2000
• Est. completion date: March 2005

Study information

• Verified date: April 2013
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• becatecarin

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ibrahim D, Hussain M, LoRusso P, et al.: Rebeccamycin analog (BMY-27557-14) in renal cell cancer (RCC): preliminary results of a phase II trial. [Abstract] Proceedings of the American Society of Clinical Oncology A-2373, 2001.