Clinical trial NCT00009919: SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
Official title: Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-01-01
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous therapy with interleukin-2. SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor

Detailed description: OBJECTIVES:

I. Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens.

II. Determine the changes in tumor perfusion in patients treated with this regimen.

III. Determine the time to progression and survival in patients treated with this regimen.

OUTLINE:

Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive an additional 6 months of therapy after achieving CR.

Patients are followed every 3 months.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic renal cell carcinoma
* Prior removal of primary tumors
* Bidimensionally measurable disease

  * Bone-only disease is not considered measurable
* Progressive disease following no more than 2 prior biologic therapy (e.g.,interleukin-2, interferon alfa, vaccine, or dendritic cell therapy) orfluorouracil-containing (single-agent or in combination therapy) regimens
* No known history of CNS metastasis unless all of the following are true:

  * Previously treated
  * Neurologically stable
  * No requirement for IV steroids or anticonvulsants
  * No requirement for oral steroids and no evidence of active or residual CNS disease on CT scan or MRI
* Negative brain scan (CT scan or MRI) required if neurologic signs or symptoms suggestive of CNS metastasis present
* Performance status - Zubrod 0-2
* At least 12 weeks
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* SGPT no greater than 2.5 times upper limit of normal
* PT and PTT normal
* Fibrinogen normal
* D-Dimer assay normal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* See Surgery
* No active congestive heart failure
* No uncontrolled angina
* No myocardial infarction or severe/unstable angina within the past 6 months
* No uncontrolled hypertension
* No uncompensated coronary artery disease on electrocardiogram or physical examination
* No severe peripheral vascular disease
* No deep vein or arterial thrombosis within the past 3 months
* No pulmonary embolism within the past 3 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent serious infection
* No overt psychosis, mental disability, or incompetence
* No diabetes mellitus
* No other prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No hypersensitivity or allergic reaction to paclitaxel
* See Disease Characteristics
* No other concurrent anti-cancer biologic therapy
* See Disease Characteristics
* No concurrent anti-cancer chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No sole indicator lesion within the previously irradiated port
* No concurrent anti-cancer radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior major surgery and recovered
* At least 1 year since prior bypass surgery for atherosclerotic coronary artery disease
* No concurrent surgery for cancer
* No other investigational drugs (e.g., analgesics or antiemetics) for at least 28 days prior to and after study

Primary outcomes:
measure: Rate of progression-free events
timeFrame: 6 months
measure: Objective response rate
timeFrame: Up to 3 years
Secondary outcomes:
measure: Survival
timeFrame: Up to 3 years
measure: Time to disease progression
timeFrame: Up to 3 years
measure: Time to treatment failure
timeFrame: Up to 3 years
measure: Duration of response
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Arlene Siefker-Radtke
role: PRINCIPAL_INVESTIGATOR
References: