Clinical trial · Interventional
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
A Phase I/II Trial of Vaccination With Mutant Ras Peptide-Pulsed Dendritic Cells in the Treatment of HLA A2.1 Positive Patients With Colorectal Cancer
- 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)
RATIONALE: Vaccines may make the body build an immune response that will kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| aldesleukin | Biological | Aldesleukin | ALIAS |
| ras peptide cancer vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate every 3 months for up to a year after completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed locally advanced or metastatic colorectal cancer * Metastatic disease must be radiologically proven * HLA-A2-1 positive * Locally advanced disease must have had prior resection or incomplete resection with poor prognosis * Locally advanced disease includes: * Stage III or IV colon cancer (T4 or any T, N2-3, M0) * Stage III or IV rectal cancer (T4 or T3, N1-3) * Resectable or unresectable T4 disease after radiotherapy, chemotherapy, and/or surgery * Absence of measurable disease but more than a 50% chance of recurrence * Completely resected or locally advanced disease may have had conventional therapy completed within 1-12 months (surgery alone, with or without adjuvant chemotherapy and/or radiotherapy) prior to study entry * Metastatic disease patients must have bidimensionally measurable disease * Bone lesions with well-demarcated borders allowed * Lesions seen only on bone scan, pleural effusions, ascites, and changes in carcinoembryonic antigen are not considered measurable disease PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Lymphocyte count at least 470/mm\^3 * Granulocyte count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL\* * SGOT no greater than 4 times upper limit of normal (ULN) (2.5 times ULN for adjuvant patients)\* * Albumin at least 3 g/dL * No active viral hepatitis * No evidence of chronic infection due to hepatitis C * Hepatitis B surface antigen negative NOTE: \*Unless due to metastatic disease Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No history of cardiac failure, significant arrhythmias, or coronary artery disease (metastatic disease patients only) Other: * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No prior malignancy with a 50% chance of recurrence within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix * No medical or psychiatric condition that would preclude compliance * No serious medical condition that would preclude apheresis * No serious infection * No uncontrolled thyroid disease (metastatic disease patients only) * Patients with an allergy to eggs are allowed but are not vaccinated against influenza during study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunologic therapy directed at the cellular immune system Chemotherapy: * See Disease Characteristics * Prior chemotherapy for metastatic disease allowed * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy or anticipated need for chemotherapy for 2 months after vaccinations Endocrine therapy: * At least 4 weeks since prior supraphysiologic steroid therapy Radiotherapy: * See Disease Characteristics * Prior radiotherapy for metastatic disease allowed * No concurrent radiotherapy Surgery: * See Disease Characteristics * Prior surgery for metastatic disease allowed
References
Publications (0)
Data not yet available