Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

NCT00126490 | Completed Phase 2 Results

• 7 other identifiers: NCI-2012-02663CDR0000434852NCI-6438MCC-IRB-102782MCC 139216438P30CA076292
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may kill more tumor cells.

Conditions

Recurrent Renal Cell Carcinoma; Stage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year

  Major response according to Response Evaluation Criteria In Solid Tumors (RECIST). CR: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  1 year

Secondary Outcomes (4)

• Number of Evaluable Participants With Overall Survival (OS) at 2 Years

  2 years from start of treatment

• Number of Evaluable Participants With Progression Free Survival (PFS)

  Up to 2 years

• Pearson Correlation Coefficients of Dendritic Cell (DC):Immature Cell (ImC) Ratio With DC Function

  At baseline, at days 4-5, 9-10 (of course 1), and at the end of treatment

• Number of Participants With Possibly Related Serious Adverse Events (SAEs)

  Up to 30 days after completion of treatment

Study Arms (1)

Treatment (bevacizumab, aldesleukin)

EXPERIMENTAL

Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

Biological: Aldesleukin; Biological: Bevacizumab; Other: Laboratory Biomarker Analysis

Interventions

Aldesleukin BIOLOGICAL

Given subcutaneously

Also known as: 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2, Recombinant Human Interleukin-2

Treatment (bevacizumab, aldesleukin)

Bevacizumab BIOLOGICAL

Given IV

Also known as: Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF

Treatment (bevacizumab, aldesleukin)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (bevacizumab, aldesleukin)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed renal cell cancer
• Metastatic disease
• More than 75% clear cell histology
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No prior refractory disease, defined as clinical or radiologic progression, during or within 3 months after completion of prior interleukin-2 (IL-2)
• Nominally "good" or "intermediate" risk disease, meeting ≥ 4 out of 5 of the following criteria:
• Hemoglobin \> 10 g/dL (except for patients with hereditary hemoglobinopathy)
• ECOG performance status 0-1 (required)
• Calcium normal (corrected)
• Patients with hypercalcemia due to malignancy allowed provided it has been controlled for \> 1 month
• Primary tumor treated or resected by complete nephrectomy, partial nephrectomy, radiofrequency ablation, or other local ablation
• Lactic dehydrogenase \< 1.5 times upper limit of normal (ULN)
• No history of or current brain or CNS metastasis by CT scan or MRI within the past 30 days
• Performance status - ECOG 0-1
• More than 4 months

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

aldesleukin; Bevacizumab; Immunoglobulin G; Disulfides

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Limitations and Caveats

Investigators planned to have 38 participants treated on this study. "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.

Results Point of Contact

• Title: Mayer Fishman, M.D., Ph.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute

mayer.fishman@moffitt.org

813-745-8311

Study Officials

• Mayer Fishman

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: August 2, 2005
• First Posted: August 4, 2005
• Study Start: March 1, 2005
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2013
• Last Updated: June 30, 2015
• Results First Posted: July 30, 2013

Record last verified: 2013-12

Locations

US (1)