Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors
18 Years
N/A
Both
Colorectal Cancer, Endometrial Cancer, Head and Neck Cancer, Liver Cancer, Lung Cancer, Melanoma (Skin), Pancreatic Cancer, Testicular Germ Cell Tumor, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Barry L. Gause, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000065656
NCT ID:
NCT00019331
Start Date:
October 1997
Completion Date:
May 2007
Related Keywords:
- Colorectal Cancer
- Endometrial Cancer
- Head and Neck Cancer
- Liver Cancer
- Lung Cancer
- Melanoma (Skin)
- Pancreatic Cancer
- Testicular Germ Cell Tumor
- Unspecified Adult Solid Tumor, Protocol Specific
- stage IV colon cancer
- recurrent non-small cell lung cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- recurrent pancreatic cancer
- recurrent colon cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- advanced adult primary liver cancer
- recurrent adult primary liver cancer
- stage IV endometrial carcinoma
- recurrent endometrial carcinoma
- stage III malignant testicular germ cell tumor
- recurrent malignant testicular germ cell tumor
- stage IV papillary thyroid cancer
- stage IV follicular thyroid cancer
- thyroid gland medullary carcinoma
- anaplastic thyroid cancer
- recurrent thyroid cancer
- stage IV melanoma
- recurrent melanoma
- stage IV non-small cell lung cancer
- unspecified adult solid tumor, protocol specific
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- adult primary hepatocellular carcinoma
- pulmonary carcinoid tumor
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV basal cell carcinoma of the lip
- stage IV verrucous carcinoma of the oral cavity
- stage IV mucoepidermoid carcinoma of the oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent basal cell carcinoma of the lip
- recurrent verrucous carcinoma of the oral cavity
- recurrent mucoepidermoid carcinoma of the oral cavity
- recurrent adenoid cystic carcinoma of the oral cavity
- stage IV squamous cell carcinoma of the oropharynx
- stage IV lymphoepithelioma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- recurrent lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage IV lymphoepithelioma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent lymphoepithelioma of the nasopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the larynx
- stage IV verrucous carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- recurrent verrucous carcinoma of the larynx
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent inverted papilloma of the paranasal sinus and nasal cavity
- recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- insular thyroid cancer
- recurrent salivary gland cancer
- stage IV salivary gland cancer
- stage IV pancreatic cancer
- Endometrial Neoplasms
- Colorectal Neoplasms
- Head and Neck Neoplasms
- Liver Neoplasms
- Lung Neoplasms
- Melanoma
- Pancreatic Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Adenoma
- Neoplasms
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
