Rebeccamycin Analog in Treating Patients With Advanced Kidney Cancer

NCT ID: NCT00005027

Last Updated: 2013-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2005-03-31

Brief 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.

Detailed 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.

Conditions

Kidney Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

becatecarin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulka N. Vaishampayan, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

References

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.

Reference Type: RESULT

Other Identifiers

U01CA062487

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-C-2063

Identifier Type: -

Identifier Source: secondary_id

NCI-T99-0113

Identifier Type: -

Identifier Source: secondary_id

CDR0000067548

Identifier Type: -

Identifier Source: org_study_id