Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

NCT00019591 | Completed Phase 1

• 3 other identifiers: CDR0000066874NCI-99-C-0023LNCI-T98-0034
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Colorectal Cancer

Keywords

stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

• Response rate every 3 months for up to a year after completion of study treatment

Interventions

aldesleukin BIOLOGICAL

ras peptide cancer vaccine BIOLOGICAL

adjuvant therapy PROCEDURE

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

aldesleukin; Chemotherapy, Adjuvant

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• John E. Janik, MD

  NCI - Metabolism Branch;MET

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 1999
• Study Completion: November 1, 2005
• Last Updated: June 20, 2013

Record last verified: 2005-11

Locations

US (2)