Study of IL2 in Combination With Zoledronic Acid in Patients With Kidney Cancer

NCT00582790 | Terminated Phase 2 Results DMC

• 4 other identifiers: HSC 2003-170CO03805A534260SMPH/MEDICINE/MEDICINE*H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to see if we can improve the response of Interleukin-2 by adding Zoledronic acid. The effectiveness of the combination of drugs in kidney cancer is unknown and will be investigated in this study. In particular, this study will evaluate the effect of this combination on kidney cancer and will also examine the safety and side effects of IL-2 with Zoledronic acid.

Conditions

Kidney Cancer

Keywords

Renal Cell Cancer; Metastatic

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Antitumor Response With Low-dose Interleukin-2 in Combination With Zoledronic Acid

  Anti-tumor response was measured per RECIST criteria (V1.0) and assessed by chest/abdomen/pelvis CT: Complete Response (CR), disappearance of all target lessions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Response (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.

  CT scans obtained at baseline, then every 2 cycles

Secondary Outcomes (3)

• Number of Participants With Overall Survival and Progression-free Survival at 24 Weeks

  Time frame is from study entry until time to disease progression and time to death, up to 50 months

• Number of Participants With Toxicities

  Baseline to 30 days after last dose of study treatment

• Number of Participants With Immunologic Responses

  baseline to cycle 2 day 8

Study Arms (1)

1

EXPERIMENTAL

Interleukin-2 subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles in combination with Zoledronic acid IV on day 1 of every 4 week (28 days) cycle.

Drug: IL2; Drug: Zoledronic acid

Interventions

IL2 DRUG

Interleukin-2 will be given at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.

Also known as: Interleukin-2

1

Zoledronic acid DRUG

Zoledronic acid will be given on day 1 intravenously over 15 or 30 minutes starting at 400mcg. If no significant increase in gamma delta-T cell augmentation is seen, the dose of zoledronic acid will be increased in the subsequent cycle up to a maximum dose of 3mg.

Also known as: Zometa

1

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 carcinoma with metastasis.
• Must have measurable disease.
• No prior cytokine, chemotherapy, hormonal, or other immuno-based therapies (including vaccine or cellular based) for their renal cancer is allowed. No prior use of bisphosphonates will be allowed. One prior experimental therapy will be permitted as long as \> 4 weeks have passed since last drug administration.
• ECOG performance status 0 or 1
• Adequate cardiac function by history.
• Pulse-oximetry \> 92% on room air.

You may not qualify if:

• Radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Known brain metastases
• Any history of an autoimmune disease (ie. psoriasis, inflammatory bowel disease, etc) must receive clearance by the investigator before being permitted on study due to the potential worsening of those disorders from IL-
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
• History of myocardial infarction or hospitalization for congestive heart failure within 12 months of enrollment.
• History of prior malignancy (except basal cell carcinoma resected with curative intent) unless resected or treated with curative intent and disease free for \> 5 years.
• Any history of seizures given increased seizure risk with IL-2.
• Organ allograft (transplant) recipients will be excluded given absolute contraindication with IL-2 therapy.
• Pregnant women are excluded
• Patients on systemic steroids (oral or IV) will not be eligible for the study.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Novartis: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

Interleukin-2; Zoledronic Acid

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study coordinator
• Organization: University of Wisconsin Carbone Cancer Center

uwcccgu@medicine.wisc.edu

(608) 263-7107

Study Officials

• Glenn Liu, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: August 1, 2003
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 25, 2019
• Results First Posted: March 19, 2013

Record last verified: 2013-03

Locations

US (1)