Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides

NCT02429440 | Unknown Phase 1

• 1 other identifier: 231/2004
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).

Conditions

Renal Cell Cancer; Advanced Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Tolerability

  Tolerability, as measured by number of Participants with Adverse Events

  Day 0-365

Secondary Outcomes (3)

• All Cause Mortality

  60 Months

• Progression-free Survival

  36 Months

• Immune Response

  Day 0-365

Study Arms (2)

Study Arm 1

EXPERIMENTAL

Intradermal application of peptide vaccine in combination with Granulocyte Macrophage Colony Stimulating Factor (GM-CSF)

Biological: peptide vaccine; Drug: Granulocyte Macrophage Colony Stimulating Factor

Study Arm 2

ACTIVE COMPARATOR

Intradermal application of peptide vaccine with Montanide ISA-51

Biological: peptide vaccine; Drug: Montanide ISA-51

Interventions

peptide vaccine BIOLOGICAL

subcutaneous

Study Arm 1; Study Arm 2

Granulocyte Macrophage Colony Stimulating Factor DRUG

intradermal

Also known as: GM-CSF

Study Arm 1

Montanide ISA-51 DRUG

subcutaneous

Study Arm 2

Eligibility Criteria

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

You may qualify if:

• Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0
• N+, M0
• M1 (after complete metastasectomy)
• ECOG performance status 0 or 1
• age \>18 years
• at least 4 weeks since last administration of radiation- or chemotherapy
• Serum levels of bilirubin \<2 mg/dl, creatinine\<2mg/dl

You may not qualify if:

• detectable distant metastasis in radiological imaging (M1)
• patients unable to consent
• severe cardiopulmonary disorder (NYHA \>= 3)
• presence of secondary malignancy
• Immunosuppressive medication (last application of glucocorticoids \> 4 weeks)
• seizure
• pregnancy
• simultaneous participation in other active or passive immunisation treatment

Sponsors & Collaborators

• University Hospital Tuebingen: lead

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Protein Subunit Vaccines; Granulocyte-Macrophage Colony-Stimulating Factor; montanide ISA 51

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)

Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Arnulf Stenzl, Prof.

  University of Tübingen, Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 29, 2015
• Study Start: May 1, 2005
• Primary Completion: October 1, 2017
• Study Completion: June 1, 2018
• Last Updated: August 17, 2017

Record last verified: 2017-08