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


Phase 2
18 Years
N/A
Not Enrolling
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

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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 SupportBethesda, Maryland  20892-1182