Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors

Colorectal Cancer Clinical Trial

Official title:

Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00019331
• Other study ID #: CDR0000065656
• Secondary ID: NCI-97-C-0141FNC
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: June 19, 2013
• Start date: October 1997
• Est. completion date: May 2007

Study information

• Verified date: April 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 and/or sargramostim may be a more effective treatment for solid tumors.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 and/or sargramostim in treating adults who have metastatic solid tumors.

Description:

OBJECTIVES:

• Determine whether endogenous cellular immunity to a tumor-specific mutated ras protein is present in cancer patients.

• Determine whether vaccination with synthetic peptides corresponding to the tumor's ras mutation with DetoxPC adjuvant, interleukin-2 (IL-2), and/or sargramostim (GM-CSF) can induce or boost a patient's cellular immunity to that particular mutation.

• Determine the type and characteristics of the cellular immune response generated.

• Determine the tolerance to and toxicity spectrum of such peptides given with DetoxPC adjuvant along with IL-2 and/or GM-CSF.

• Correlate immune response with tumor response in patients treated with these regimens.

OUTLINE: Patients are assigned to one of three treatment groups.

• Group I (closed to accrual 6/4/01): Patients receive tumor-specific ras peptide vaccine with DetoxPC subcutaneously (SC) once every 5 weeks for 3 courses. Beginning 4 days after vaccination, patients receive interleukin-2 (IL-2) SC 5 days a week for 2 weeks.

• Group II (closed to accrual 6/4/01): Patients receive sargramostim (GM-CSF) SC daily beginning 1 day prior to the vaccination and continuing for 4 days. Patients receive the vaccination as in group I immediately followed by GM-CSF on day 2. Patients are vaccinated once every 4 weeks for 3 courses.

• Group III: Patients receive the vaccination and IL-2 as in group I and GM-CSF as in group II.

In all groups, patients receive up to 15 vaccinations in the absence of disease progression.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A maximum of 60 patients (20 per treatment group) will be accrued for this study within 2-4 years.

Other known NCT identifiers

• NCT00001581

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumors potentially expressing mutant ras, including colon, lung, pancreas, thyroid, endometrial, head and neck, testicular, hepatocellular, and melanoma

• Ras mutations must be one of the following point mutations at codon 12:

• Glycine to cysteine

• Glycine to aspartic acid

• Glycine to valine

• Metastatic disease for which no known chemotherapy or radiotherapy would increase survival

• Tumor tissue must be available for determination of ras mutation

• No prior CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• SGOT/SGPT no greater than 4 times normal

• No hepatitis B or C infection

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No active ischemic heart disease (New York Heart Association class III or IV)

• No myocardial infarction within the past 6 months

• No history of congestive heart failure, ventricular arrhythmias, or other arrhythmias requiring therapy

Immunologic:

• No prior allergy to eggs

• No prior autoimmune disease, including the following:

• Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia

• Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma

• Myasthenia gravis

• Goodpasture syndrome

• Addison's disease, Hashimoto's thyroiditis, or active Graves' disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer

• No active infection requiring antibiotics

• No medical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

• At least 4 weeks since prior steroids and recovered

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Endometrial Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Melanoma (Skin)
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Pancreatic Cancer
• Pancreatic Neoplasms
• Testicular Germ Cell Tumor
• Testicular Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• aldesleukin

• ras peptide cancer vaccine

• sargramostim

Drug:
• DetoxPC

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,