Clinical trial · Interventional
Alpha-type-1 Dendritic Cell-based Vaccines in Patients With Metastatic Colorectal Cancer
Phase I Evaluation of Semi-continuous Alpha-type-1 Dendritic Cell-based Vaccines in Patients With Metastatic Colorectal Cancer
NCT00558051CI-TRIAL-00021591completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the administration, safety and immunologic effectiveness of an experimental vaccine for colorectal cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DC-based vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Intradermal administration
- description
- Intradermal administration
- interventionNames
- Biological: DC-based vaccine
- type
- ACTIVE_COMPARATOR
- label
- Intranodal administration
- description
- Intranodal administration
- interventionNames
- Biological: DC-based vaccine
- type
- ACTIVE_COMPARATOR
- label
- Intralymphatic infusion
- description
- Intralymphatic infusion
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDRadomski 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