Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment
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|ClinicalTrials.gov Identifier: NCT00678119|
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : July 15, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Biological: AGS-003 Drug: Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Testing the Safety and Activity of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Advanced Stage Renal Cell Carcinoma in Combination With Sunitinib|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: 1: AGS-003+sunitinib
Single arm study AGS-003 plus sunitinib
Dendritic cell Immunotherapeutic
An approved drug for the treatment of RCC
Other Name: Sutent
- Clinical antitumor activity will be assessed as an objective tumor response as defined by RECIST. Tumor response is documented using standard definitions of CR and must be confirmed no less than 4 weeks after the criteria for response are first met. [ Time Frame: 24 weeks ]
- The monitoring of clinical activity, immune response and safety across multiple doses. [ Time Frame: 24 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Male and female subjects ≥18 years of age with newly diagnosed advanced stage RCC will be eligible for inclusion in this study if all of the following criteria apply:
- Newly diagnosed advanced stage RCC.
- Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has lesion accessible for excisional biopsy/metastasectomy.
- Measurable disease.
- Candidate for sunitinib treatment as labeled.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Memorial Sloan Kettering Cancer Center (MSKCC) risk group 0 or 1.
- No brain metastases detected by MRI.
- Normal renal function in the contralateral kidney.
- Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
- Use of appropriate birth control methods for the duration of the study for women of childbearing potential and men with female partners of childbearing potential.
Clinically acceptable Screening results according to the following specific limits:
- Adequate hematologic function.
- Adequate renal and hepatic function.
- Adequate coagulation function.
- Normal serum calcium.
- Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
- Voluntary informed consent given to participate in the study.
Subjects will NOT be eligible for inclusion in this study if any of the following criteria apply:
- Nephrectomy for RCC therapy is required.
- Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
- Uncontrolled hypertension.
- Type I diabetes mellitus (insulin therapy for Type II diabetes IS permitted).
- Prior systemic therapy for advanced stage RCC.
- Active autoimmune disease.
- Prior history of malignancy other than RCC within the preceding 5 years, except for adequately treated cervical cancer or non-melanoma skin cancer.
- Use of prohibited prescription or prohibited non-prescription drugs during 2 months prior to entry into the study.
- Active, acute, or chronic clinically significant infections.
- Use of another investigational drug or participation in any investigational drug study within the 28 days prior to the start of study enrollment.
- Planned or elective anti-cancer surgical treatment other than nephrectomy/excisional biopsy/metastasectomy.
- History of hypercalcemia, symptomatic hypercalcemia, or hypercalcemia requiring management.
- Known hypersensitivity to dimethyl sulfoxide (DMSO).
- Body weight less than 30 kg.
- Pregnancy or lactation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678119
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Los Angeles, California, United States, 90095|
|United States, Colorado|
|The Urology Center of Colorado|
|Denver, Colorado, United States, 80211|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Indiana|
|The Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Kansas|
|University of Kansas Hospital|
|Kansas City, Kansas, United States, 66160|
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, North Carolina|
|Carolina's Medical Center / Blumenthal Cancer Center|
|Charlotte, North Carolina, United States, 28204|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45267|
|United States, Texas|
|Dallas, Texas, United States, 75230|
|United States, Virginia|
|Urology of Virginia-Sentara Medical Group|
|Norfolk, Virginia, United States, 23502|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G2M9|
|Jewish General Hospital|
|Montreal, Quebec, Canada, H3T1E2|
|Study Director:||Fred Miesowicz||Argos Therapeutics|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Argos Therapeutics|
|Other Study ID Numbers:||
|First Posted:||May 15, 2008 Key Record Dates|
|Last Update Posted:||July 15, 2013|
|Last Verified:||July 2013|
Renal Cell Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Angiogenesis Modulating Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action