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A Phase II Study of Rebeccamycin Analog in Renal Cell Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

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Trial Information

A Phase II Study of Rebeccamycin Analog in Renal Cell Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ulka N. Vaishampayan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067548

NCT ID:

NCT00005027

Start Date:

June 2000

Completion Date:

March 2005

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201