Alpha-type-1 Dendritic Cell-based Vaccines in Patients With Metastatic Colorectal Cancer

NCT00558051 | Completed Phase 1 DMC

• 1 other identifier: 05-063
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the administration, safety and immunologic effectiveness of an experimental vaccine for colorectal cancer patients.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal Cancer; Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study is to evaluate the feasibility and safety of semi-continuous intralymphatic vaccination dendritic cells.

  4 to 14 weeks

Secondary Outcomes (1)

• The secondary objective of this study is to evaluate the immunity results from either single injections or semi-continuous infusion, intradermal or intranodal, administered immunization with the DC vaccine for colorectal cancer (CRC) patients.

  4 to 14 weeks

Study Arms (3)

Intradermal administration

ACTIVE COMPARATOR

Intradermal administration

Biological: DC-based vaccine

Intranodal administration

ACTIVE COMPARATOR

Intranodal administration

Biological: DC-based vaccine

Intralymphatic infusion

ACTIVE COMPARATOR

Intralymphatic infusion

Biological: DC-based vaccine

Interventions

DC-based vaccine BIOLOGICAL

Each patient will receive four courses of vaccination with 2 million tumor-loaded DCs at week 0, 4, 8, and 12. A course consists of 4 intradermal injections once a day for 4 days.

Intradermal administration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic colorectal cancer with minimal evidence of disease or resectable metastases (to include extra-hepatic metastases).
• Availability of metastatic tumor material, from hepatic metastasis and additional sites, that can be resected under sterile conditions for autologous vaccine preparation (not all tumors harvested will be of sufficient quantity or quality to make vaccine, therefore some subjects may not receive vaccine).
• No chemotherapy, radiotherapy, major surgery, or biologic therapy for their malignancy in the 4 weeks prior to the vaccine administration and must have recovered from all side effects.
• An ECOG performance standard of 0, 1 or 2.
• Adequate hepatic function as evidenced by bilirubin \< 2.0 mg/dL and a PT \< 2 seconds of the upper limit of normal.
• Age equal to 18 years or older and greater than 30 kg.
• Platelet counts greater than 100,000, a hematocrit \> 27.0, a white blood count \> 3000/µl, and a creatinine less than or equal to 1.5 mg/dL or a creatinine clearance of \> 60 mL/min.
• Aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits and risks, and willing to sign an informed consent.
• Patients must be able to understand and be willing to sign a written informed consent document.

You may not qualify if:

• Subjects currently treated with systemic immunosuppressive agents, including steroids, are ineligible until 4 weeks after removal from immunosuppressive treatment. Subjects on maintenance steroids because of adrenal insufficiency are eligible.
• Subjects with severely abnormal liver function tests \[AST (SGOT), ALT (SGPT), GGT, Alk.Phos, LDH, and total bilirubin greater than 2 X ULN\]
• Subjects with uncontrolled pain.
• Subjects with active autoimmune disease, positive serology for HIV, HBV, or HCV (testing will be performed with FDA licensed blood donor tests).
• Subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix).
• Subjects who are allergic to or develop an allergy to heparin.
• Subjects who are pregnant.
• Subjects who have sensitivity to drugs that provide local anesthesia.

Sponsors & Collaborators

• Pawel Kalinski: lead

Study Sites (1)

University of Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• Radomski M, Zeh HJ, Edington HD, Pingpank JF, Butterfield LH, Whiteside TL, Wieckowski E, Bartlett DL, Kalinski P. Prolonged intralymphatic delivery of dendritic cells through implantable lymphatic ports in patients with advanced cancer. J Immunother Cancer. 2016 Apr 19;4:24. doi: 10.1186/s40425-016-0128-y. eCollection 2016.

  PMID: 27096100 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• David L. Bartlett, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2014
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

US (1)