Ispinesib in Treating Patients With Metastatic or Unresectable Kidney Cancer

NCT00354250 | Completed Phase 2

• 3 other identifiers: NCI-2012-0292814577AN01CM62201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well ispinesib works in treating patients with metastatic or unresectable kidney cancer. Ispinesib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate defined as the proportion of patients who achieve a complete or partial response with ispinesib evaluated per RECIST

  If the response rate is 30% or more, further study would be proposed based on the estimates produced in this trial. Will be presented along with 95% confidence intervals.

  Up to 4 years

Secondary Outcomes (3)

• Overall survival

  Up to 4 years

• Time to progression

  Up to 4 years

• Qualitative and quantitative toxicities of this regimen graded according to NCI CTCAE

  Up to 4 years

Study Arms (1)

Treatment (ispinesib)

EXPERIMENTAL

Patients receive ispinesib (SB-715992) IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: ispinesib

Interventions

ispinesib DRUG

Given IV

Also known as: CK0238273, SB-715992

Treatment (ispinesib)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed renal cell carcinoma which is metastatic (M1); histopathology is not restricted; patients with unresectable primary tumor (but MO) are also eligible
• Patients must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration
• Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
• Patients must have discontinued therapy due to toxicity or demonstrated progression of disease following a minimum of one prior therapy; prior therapies may include: immunotherapy with either interferon (IFN) and/or Interleukin-2 (IL-2) or prior anti-angiogenesis agents; at least 28 days must have elapsed since the last treatment; patients must have recovered from any adverse effects of prior therapy
• Patients may have received prior radiation therapy; at least 21 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
• Patients may not have received prior tubule, DNA, or mitosis targeting agents for the treatment of renal cell carcinoma
• Patients must have a ECOG performance status of 0 - 2
• Pregnant or nursing women may not participate in this trial; women and men of reproductive potential must have agreed to use an effective contraceptive method; women of child-bearing potential must have a negative urine pregnancy test
• Patients with a history of brain metastases or who currently have treated or untreated brain metastases are not eligible; patients with clinical evidence of brain metastases must have a brain CT or MRI negative for metastatic disease within 56 days prior to registration
• Absolute granulocyte count (AGC) ≥ 1,500 cells/mm3, hemoglobin ≥ 9 mg/dl, and a platelet count ≥ 100,000 cells/mm3 within 14 days prior to registration
• Patients must have a total bilirubin \< 2 mg/dl obtained within 14 days prior to registration
• Patients must have SGOT and SGPT =\< 2.5 x institutional upper limit of normal within 14 days prior to registration
• Patients must have a serum creatinine =\< 2.0 or a calculated creatinine clearance \>= 40 mL/min for patients with creatinine levels above institutional normal; this must be obtained within 14 days prior to registration
• Patients must have a corrected QT interval less than 0.47 seconds
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

ispinesib; CK0238273

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Walter Stadler

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 20, 2006
• Study Start: May 1, 2006
• Primary Completion: February 1, 2007
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)